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A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

Primary Purpose

COPD, COPD Exacerbation

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Beclomethasone Dipropionate

Glycopyrronium Bromide

Formoterol Fumarate

About this trial

This is an interventional treatment trial for COPD focused on measuring Lung Function, Safety Profile, Beclomethasone Dipropionate, Glycopyrronium Bromide, Formoterol Fumarate

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed and dated written informed consent must be obtained prior to initiating any study-related procedures
Outpatient
Male or female subjects aged ≥40 years
A female is eligible to participate in the study if she is of non-childbearing potential defined as physiologically incapable of becoming pregnant OR childbearing potential with negative serum and urine pregnancy tests at screening, and is willing to use highly effective birth control methods for the full duration of the study
COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report
Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20]
COPD Assessment Test (CAT) score ≥10
A pre- and post-bronchodilator FEV1/FVC ratio <0.70 at screening
A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal at screening and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months
Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits
Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD).
A cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary.

Exclusion Criteria:

Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating
Subjects using the following medications prior to the screening visit and during the run-in period:
1. Systemic/oral/parenteral corticosteroids in the prior 4 weeks
2. Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks
3. Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks
4. Oral xanthine derivatives (e.g. theophylline) in the prior 7 days
A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period
Current treatment with non-cardioselective β-blockers
Requirement of long term (> 15 hours daily) oxygen therapy
Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement.
Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit)
Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents
History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement
Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months
An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit. This is characterized as but not limited to any of the following findings:
1. Atrial fibrillation (AF) with rapid ventricular response > 120 bpm
2. Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec])
3. Evidence of Mobitz Type II second degree or third-degree atrioventricular block
4. Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF.
Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement
Unstable or uncontrolled concurrent disease which may impact the efficacy or safety of the study drug or the subject's participation in the study according to investigator's judgment
Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas
History of alcohol abuse and/or substance/drug abuse (including marijuana inhaled and oral) within 12 months prior to the screening visit
Receipt of any other investigational drug within 1 month or 5 half-lives (whichever is greater) prior to the screening visit or have been previously randomized in this trial, or are currently participating in another clinical trial
Currently in the acute phase of a pulmonary rehabilitation program within 4 weeks before the screening visit or planning to enroll in the acute phase of such a program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded
Mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order
Major surgery in the 3 months prior to the screening visit or have a planned surgery during the trial
Non-satisfactory compliance with the eDiary (<65% or >135%) during the run-in period
Subjects requiring the use of spacer device or nebulizer for administration of maintenance COPD therapies.
Veins unsuitable for repeat venipuncture
Blood donation or blood loss (≥450mL) in the 4 weeks before randomization

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BDP/FF/GB - CHF 5993

BDP/FF - CHF 1535

Arm Description

Two inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler

Two inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler

Outcomes

Primary Outcome Measures

Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28

Secondary Outcome Measures

Change from baseline in 2-hour post-dose morning FEV1 at Week 28

Rate of moderate and severe COPD exacerbations over 52 weeks of treatment

Annualized rate of moderate and severe COPD exacerbations as observed during the 52-week study treatment period.

Change from baseline in pre-dose morning FEV1 at designated clinic visits

Change from baseline in 2-hour post-dose morning FEV1 designated clinic visits

Change from pre-dose to 2-hour post-dose morning FEV1 at designated clinic visits

FEV1 response (change from baseline in pre-dose morning FEV1 ≥100ml) at designated clinic visits

Time to first moderate or severe COPD exacerbation

Rate of severe COPD exacerbations over 52 weeks of treatment

Annualized rate of severe COPD exacerbations as observed during 52-week treatment period

Time to first severe COPD exacerbation

Saint George's Respiratory Questionnaire (SGRQ) response (a decrease from baseline in total score ≥4) at designated clinic visits

Change from baseline in the SGRQ total score and domain scores at each designated clinic visit

Change from baseline to each inter-visit period in the percentage of days without intake of rescue medication

Change from baseline (defined as the 2-week run-in period prior to randomization) to each inter-visit period (defined as the period of time between designated clinic visits) in percentage of days without rescue medication

Change from baseline to each inter-visit period in the average use of rescue medication (number of puffs/day)

Change from baseline (defined as the 2-week run-in period prior to randomization) in the average number of puffs per day of rescue medication for each inter-visit period (defined as the period of time between designated clinic visits).

Change from baseline in pre-dose morning Forced Vital Capacity (FVC) at designated clinic visits

Change from baseline in 2-hour post-dose morning FVC at designated clinic visits

Change from baseline (defined as the pre-dose value on Day 1) in 2-hour post-dose morning FVC at designated clinic visits

Change from pre-dose to 2-hour post-dose morning FVC at designated clinic visits

Change from baseline to each inter-visit period in the average E-RS total score and domain scores

Change from baseline (defined as the 2-week run-in period prior to randomization) in the average E-RS total score and E-RS domain scores for the period of time between designated clinic visits.

Change from baseline in COPD Assessment Test (CAT) score at designated clinic visit

The CAT is composed of 8 questions to measure the impact of COPD on daily life, which are scored from 0 to 5 with higher scores reflecting greater impact.

CAT response (decrease from baseline ≥2 points) at designated clinic visits

Modified Medical Research Council (mMRC) dyspnea scale at designated clinic visits

Descriptive statistics of the mMRC dyspnea scale score at designated clinic visits. The mMRC dyspnea scale is graded from 0 to 4, with higher grades reflecting greater severity.

Change from baseline in health-related quality of life (decrease from baseline in total SGRQ score ≥4) over 52 weeks of treatment.

Full Information

NCT ID

NCT04320342

First Posted

March 23, 2020

Last Updated

February 6, 2023

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT04320342

Brief Title

A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

Acronym

TRITON

Official Title

A Phase III, 52-week, Multinational, Multicenter, Randomized, Double-blind, 2-arm Parallel Group Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide (CHF 5993) With the Fixed Dose Dual Combination of Beclomethasone Dipropionate Plus Formoterol Fumarate (CHF 1535), Both Administered Via pMDI in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 28, 2022 (Actual)

Primary Completion Date

July 2024 (Anticipated)

Study Completion Date

July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chiesi Farmaceutici S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.

Detailed Description

This is a phase III, multinational, multicenter, randomized, double-blind active controlled 2-arm parallel group study to compare efficacy, safety, and tolerability of CHF 5993 pMDI with CHF 1535 pMDI with respect to lung function, incidence of moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes. After screening, eligible subjects will enter 2-week run-in period using their regular COPD maintenance therapies after which they will be randomized to one of 2 study treatment groups. Following randomization, subjects will be assessed after 4 weeks then at 6-week intervals thereafter for a period of 52 weeks. A follow-up safety phone call will be performed a week after the last clinic visit. A subset of subjects consenting to participate in the pharmacokinetic substudy will undergo additional assessments (totaling 3 visits) during the scheduled study visits. During the study, daily symptoms, rescue medication use and compliance with the study drug will be recorded via a subject electronic diary. Subject concomitant medications, adverse events, and healthcare resource utilization will be assessed and recorded throughout the study. At intermittent study visits, subjects will undergo vital signs examinations including weight, spirometry measurements, and 12-lead ECG. Symptoms and COPD health status will be assessed through disease specific questionnaires. Routine hematology, blood chemistry, and serum pregnancy testing will be performed before enrollment and at end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, COPD Exacerbation

Keywords

Lung Function, Safety Profile, Beclomethasone Dipropionate, Glycopyrronium Bromide, Formoterol Fumarate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

2934 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

BDP/FF/GB - CHF 5993

Arm Type

Experimental

Arm Description

Two inhalations twice daily of BDP/FF/GB (100/6/12.5μg) for a period of 52 weeks via pressurized metered dose inhaler

Arm Title

BDP/FF - CHF 1535

Arm Type

Active Comparator

Arm Description

Two inhalations twice daily of BDP/FF (100/6μg) for a period of 52 weeks via pressurized metered dose inhaler

Intervention Type

Drug

Intervention Name(s)

Beclomethasone Dipropionate

Other Intervention Name(s)

BDP

Intervention Description

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

Intervention Type

Drug

Intervention Name(s)

Glycopyrronium Bromide

Other Intervention Name(s)

glycopyrrolate, GB

Intervention Description

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg

Intervention Type

Drug

Intervention Name(s)

Formoterol Fumarate

Other Intervention Name(s)

Intervention Description

Available in pressurized inhalation solution BDP/FF/GB 100/6/12.5μg and BDP/FF 100/6μg

Primary Outcome Measure Information:

Title

Change from baseline in pre-dose morning Forced Expiratory Volume in the 1st second (FEV1) at Week 28

Time Frame

Week 28

Secondary Outcome Measure Information:

Title

Change from baseline in 2-hour post-dose morning FEV1 at Week 28

Time Frame

Week 28

Title

Rate of moderate and severe COPD exacerbations over 52 weeks of treatment

Description

Annualized rate of moderate and severe COPD exacerbations as observed during the 52-week study treatment period.

Time Frame

52-week treatment period

Title

Change from baseline in pre-dose morning FEV1 at designated clinic visits

Time Frame

Week 4, Week 10, Week 40, & Week 52

Title

Change from baseline in 2-hour post-dose morning FEV1 designated clinic visits

Time Frame

Day 1, Week 4, Week 10, Week 40, & Week 52

Title

Change from pre-dose to 2-hour post-dose morning FEV1 at designated clinic visits

Time Frame

Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Title

FEV1 response (change from baseline in pre-dose morning FEV1 ≥100ml) at designated clinic visits

Time Frame

Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Time to first moderate or severe COPD exacerbation

Time Frame

52-week treatment period

Title

Rate of severe COPD exacerbations over 52 weeks of treatment

Description

Annualized rate of severe COPD exacerbations as observed during 52-week treatment period

Time Frame

52-week treatment period

Title

Time to first severe COPD exacerbation

Time Frame

52-week treatment period

Title

Saint George's Respiratory Questionnaire (SGRQ) response (a decrease from baseline in total score ≥4) at designated clinic visits

Time Frame

Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Change from baseline in the SGRQ total score and domain scores at each designated clinic visit

Time Frame

Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Change from baseline to each inter-visit period in the percentage of days without intake of rescue medication

Description

Time Frame

Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

Title

Change from baseline to each inter-visit period in the average use of rescue medication (number of puffs/day)

Description

Time Frame

Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

Title

Change from baseline in pre-dose morning Forced Vital Capacity (FVC) at designated clinic visits

Time Frame

Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Change from baseline in 2-hour post-dose morning FVC at designated clinic visits

Description

Change from baseline (defined as the pre-dose value on Day 1) in 2-hour post-dose morning FVC at designated clinic visits

Time Frame

Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Change from pre-dose to 2-hour post-dose morning FVC at designated clinic visits

Time Frame

Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Change from baseline to each inter-visit period in the average E-RS total score and domain scores

Description

Change from baseline (defined as the 2-week run-in period prior to randomization) in the average E-RS total score and E-RS domain scores for the period of time between designated clinic visits.

Time Frame

Day 1-Week 4, Week 4-Week 10, Week 10-Week 28, Week 28-Week 40, Week 40-Week 52

Title

Change from baseline in COPD Assessment Test (CAT) score at designated clinic visit

Description

The CAT is composed of 8 questions to measure the impact of COPD on daily life, which are scored from 0 to 5 with higher scores reflecting greater impact.

Time Frame

Week 4, Week 10, Week 28, Week 40, & Week 52

Title

CAT response (decrease from baseline ≥2 points) at designated clinic visits

Time Frame

Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Modified Medical Research Council (mMRC) dyspnea scale at designated clinic visits

Description

Descriptive statistics of the mMRC dyspnea scale score at designated clinic visits. The mMRC dyspnea scale is graded from 0 to 4, with higher grades reflecting greater severity.

Time Frame

Day 1, Week 4, Week 10, Week 28, Week 40, & Week 52

Title

Change from baseline in health-related quality of life (decrease from baseline in total SGRQ score ≥4) over 52 weeks of treatment.

Time Frame

52-week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Signed and dated written informed consent must be obtained prior to initiating any study-related procedures Outpatient Male or female subjects aged ≥40 years A female is eligible to participate in the study if she is of non-childbearing potential defined as physiologically incapable of becoming pregnant OR childbearing potential with negative serum and urine pregnancy tests at screening, and is willing to use highly effective birth control methods for the full duration of the study COPD diagnosis for at least 12 months before the screening visit in accordance with the definition by the GOLD 2020 Report Current or ex-smokers who quit smoking at least 6 months prior to screening with a smoking history of at least 10 pack-years [pack-years = (number of cigarettes per day x number of years)/20] COPD Assessment Test (CAT) score ≥10 A pre- and post-bronchodilator FEV1/FVC ratio <0.70 at screening A post-bronchodilator FEV1 <50% predicted normal at screening and a documented history of ≥1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator FEV1 ≥50% and <80% of predicted normal at screening and a documented history of ≥2 moderate COPD exacerbations or ≥1 severe COPD exacerbation in the previous 12 months Subjects receiving daily inhaled maintenance therapy for their COPD, at a stable dose for at least 3 months prior to the screening and randomization visits Documentation (including imagery and report) of chest x-ray (CXR) or CT scan performed within 6 months prior to the screening visit, without evidence of significant abnormalities (other than those related to the presence of COPD). A cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary. Exclusion Criteria: Female subjects who are pregnant (as evident by a positive urine hCG or serum β-hCG test) or lactating Subjects using the following medications prior to the screening visit and during the run-in period: Systemic/oral/parenteral corticosteroids in the prior 4 weeks Use of antibiotics for a lower respiratory tract infection (e.g. pneumonia) or COPD exacerbation in the prior 4 weeks Any long-term chronic maintenance use of antibiotic treatment in the prior 4 weeks Oral xanthine derivatives (e.g. theophylline) in the prior 7 days A moderate or severe COPD exacerbation or a respiratory tract infection (e.g., pneumonia) that has not resolved ≤14 days prior to the screening visit or during the run-in period Current treatment with non-cardioselective β-blockers Requirement of long term (> 15 hours daily) oxygen therapy Known respiratory disorders other than COPD which may impact the efficacy of the study drug according to investigator's judgement. Lung transplant surgery or lung volume reduction surgery (subjects with lung volume reduction surgery are excluded if the procedure was performed within 1 year before the Screening visit) Medical diagnosis of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the investigator, would prevent use of anticholinergic agents History of hypersensitivity to M3 receptor antagonists, β2 agonists, corticosteroids or any of the excipients contained in any of the study drugs used in the trial which may raise contra-indications or impact the efficacy of the study drug according to the investigator's judgement Subject has severe, acute or uncontrolled cardiovascular condition (such as but not limited to unstable ischemic heart disease, NYHA Class IV, left ventricular failure, acute myocardial infarction or unstable angina) in the last 6 months An abnormal and clinically significant 12-lead ECG at either the screening or randomization visit. This is characterized as but not limited to any of the following findings: Atrial fibrillation (AF) with rapid ventricular response > 120 bpm Ventricular tachycardias (sustained, non-sustained [>3 up to 30 sec]) Evidence of Mobitz Type II second degree or third-degree atrioventricular block Prolonged QTcF (>450ms for males, or >470ms for females). This criterion is not applicable for subjects with a pacemaker or permanent AF. Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study drug according to investigator's judgement Unstable or uncontrolled concurrent disease which may impact the efficacy or safety of the study drug or the subject's participation in the study according to investigator's judgment Malignancy that has not been in complete remission for at least 1 year or any untreated localized carcinomas History of alcohol abuse and/or substance/drug abuse (including marijuana inhaled and oral) within 12 months prior to the screening visit Receipt of any other investigational drug within 1 month or 5 half-lives (whichever is greater) prior to the screening visit or have been previously randomized in this trial, or are currently participating in another clinical trial Currently in the acute phase of a pulmonary rehabilitation program within 4 weeks before the screening visit or planning to enroll in the acute phase of such a program during the study. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded Mentally or legally incapacitated, or subjects incarcerated as a result of an official or judicial order Major surgery in the 3 months prior to the screening visit or have a planned surgery during the trial Non-satisfactory compliance with the eDiary (<65% or >135%) during the run-in period Subjects requiring the use of spacer device or nebulizer for administration of maintenance COPD therapies. Veins unsuitable for repeat venipuncture Blood donation or blood loss (≥450mL) in the 4 weeks before randomization

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chiesi Clinical Trial Info

Phone

+39 0521 2791

clinicaltrials_info@chiesi.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory M Feldman, MD

Organizational Affiliation

Vitalink Research - Spartanburg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chiesi Clinical Trial Site 840186

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36303

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hristo Metev, MD

Facility Name

Chiesi Clinical Trial Site 840258

City

Foley

State/Province

Alabama

ZIP/Postal Code

36535

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rocio Barriga, MD

Facility Name

Chiesi Clinical Trial Site 840279

City

Jasper

State/Province

Alabama

ZIP/Postal Code

35501

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danuta Madra-Rogacka, MD

Facility Name

Chiesi Clinical Trial Site 840206

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840190

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840209

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840144

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Pedro Elias, MD

Facility Name

Chiesi Clinical Trial Site 840173

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840208

City

Northridge

State/Province

California

ZIP/Postal Code

91324

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840226

City

Sacramento

State/Province

California

ZIP/Postal Code

95821

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840107

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840164

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840174

City

West Covina

State/Province

California

ZIP/Postal Code

91790

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dimo Dimov, MD

Facility Name

Chiesi Clinical Trial Site 840229

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80302

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zsuzsanna Cseke, MD

Facility Name

Chiesi Clinical Trial Site 840268

City

Aventura

State/Province

Florida

ZIP/Postal Code

33180

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840192

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840240

City

Chiefland

State/Province

Florida

ZIP/Postal Code

32626

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Erika Unger, MD

Facility Name

Chiesi Clinical Trial Site 840153

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33756

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Patricia Malamud, MD

Facility Name

Chiesi Clinical Trial Site 840272

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanna Piskorz-Wapinska, MD

Facility Name

Chiesi Clinical Trial Site 840304

City

Coral Gables

State/Province

Florida

ZIP/Postal Code

33134

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcin Bednarek, MD

Facility Name

Chiesi Clinical Trial Site 840141

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Individual Site Status

Withdrawn

Facility Name

Chiesi Clinical Trial Site 840133

City

DeLand

State/Province

Florida

ZIP/Postal Code

32720

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840303

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33010

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Mroz, MD

Facility Name

Chiesi Clinical Trial Site 840163

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nicolas Javier Destefani Villafane, MD

Facility Name

Chiesi Clinical Trial Site 840165

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Carlos Victorio, MD

Facility Name

Chiesi Clinical Trial Site 840238

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Orsolya Lovasz, MD

Facility Name

Chiesi Clinical Trial Site 840241

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840253

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33015

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840184

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aleksandar Lilov, MD

Facility Name

Chiesi Clinical Trial Site 840267

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840200

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840232

City

Lakeland

State/Province

Florida

ZIP/Postal Code

33803

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840288

City

Miami Lakes

State/Province

Florida

ZIP/Postal Code

33016

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Danuta Wronska, MD

Facility Name

Chiesi Clinical Trial Site 840137

City

Miami

State/Province

Florida

ZIP/Postal Code

33125

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Donald Quinn, MD

Facility Name

Chiesi Clinical Trial Site 840180

City

Miami

State/Province

Florida

ZIP/Postal Code

33126

Country

United States

Individual Site Status

Withdrawn

Facility Name

Chiesi Clinical Trial Site 840175

City

Miami

State/Province

Florida

ZIP/Postal Code

33133

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840205

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Blagoy Marinov, MD

Facility Name

Chiesi Clinical Trial Site 840247

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dante Hernandez Colin, MD

Facility Name

Chiesi Clinical Trial Site 840148

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rocio Fernandez Bazerque, MD

Facility Name

Chiesi Clinical Trial Site 840193

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milkana Simeonova, MD

Facility Name

Chiesi Clinical Trial Site 840239

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriella Tamas, MD

Facility Name

Chiesi Clinical Trial Site 840237

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840261

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840262

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis Natera Ramirez, MD

Facility Name

Chiesi Clinical Trial Site 840280

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bernadetta Majorek-Olechowska, MD

Facility Name

Chiesi Clinical Trial Site 840178

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Vanya Dimova Ilieva-Fartunova, MD

Facility Name

Chiesi Clinical Trial Site 840202

City

Miami

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Todor Popov, MD

Facility Name

Chiesi Clinical Trial Site 840275

City

Miami

State/Province

Florida

ZIP/Postal Code

33169

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Slawomir Tokarski, MD

Facility Name

Chiesi Clinical Trial Site 840122

City

Miami

State/Province

Florida

ZIP/Postal Code

33173

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840235

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Aniko Kurucz, MD

Facility Name

Chiesi Clinical Trial Site 840243

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Raul Aguilar, MD

Facility Name

Chiesi Clinical Trial Site 840244

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840257

City

Miami

State/Province

Florida

ZIP/Postal Code

33175

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Alejandra Ramirez Venegas, MD

Facility Name

Chiesi Clinical Trial Site 840162

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840166

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840140

City

Mount Dora

State/Province

Florida

ZIP/Postal Code

32757

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840263

City

New Port Richey

State/Province

Florida

ZIP/Postal Code

34652

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840161

City

North Miami Beach

State/Province

Florida

ZIP/Postal Code

33160

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gonzalo Saenz, MD

Facility Name

Chiesi Clinical Trial Site 840132

City

North Miami

State/Province

Florida

ZIP/Postal Code

33161

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Hudman Hoo, MD

Facility Name

Chiesi Clinical Trial Site 840255

City

Orlando

State/Province

Florida

ZIP/Postal Code

32807

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Efrain Montano-Gonzalez, MD

Facility Name

Chiesi Clinical Trial Site 840110

City

Orlando

State/Province

Florida

ZIP/Postal Code

32822

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Omari Ruffin, MD

Facility Name

Chiesi Clinical Trial Site 840125

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840121

City

Palmetto Bay

State/Province

Florida

ZIP/Postal Code

33157

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jan Westerman, MD

Facility Name

Chiesi Clinical Trial Site 840196

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840198

City

Pembroke Pines

State/Province

Florida

ZIP/Postal Code

33024

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Margarita Taseva, MD

Facility Name

Chiesi Clinical Trial Site 840252

City

Pompano Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Sanchez Llamas, MD

Facility Name

Chiesi Clinical Trial Site 840291

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33704

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Barbara Rewerska, MD

Facility Name

Chiesi Clinical Trial Site 840290

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33709

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Anna Olech-Cudzik, MD

Facility Name

Chiesi Clinical Trial Site 840131

City

Tampa

State/Province

Florida

ZIP/Postal Code

33613

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840309

City

Tampa

State/Province

Florida

ZIP/Postal Code

33634

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Teresa Hofman, MD

Facility Name

Chiesi Clinical Trial Site 840210

City

The Villages

State/Province

Florida

ZIP/Postal Code

32162

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840256

City

Virginia Gardens

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840223

City

Adairsville

State/Province

Georgia

ZIP/Postal Code

30103

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lenka Povysilova, MD

Facility Name

Chiesi Clinical Trial Site 840218

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840227

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840138

City

Rincon

State/Province

Georgia

ZIP/Postal Code

31326

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840207

City

Crowley

State/Province

Louisiana

ZIP/Postal Code

70526

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Rumen Stoyanov Tiholov, MD

Facility Name

Chiesi Clinical Trial site 840250

City

North Dartmouth

State/Province

Massachusetts

ZIP/Postal Code

02747

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840183

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48336

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mihail Kirov, MD

Facility Name

Chiesi Clinical Trial Site 840287

City

Southfield

State/Province

Michigan

ZIP/Postal Code

48034

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ewa Trawinska, MD

Facility Name

Chiesi Clinical Trial Site 840278

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Miroslaw Necki, MD

Facility Name

Chiesi Clinical Trial Site 840155

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840150

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gabriel Garcia, MD

Facility Name

Chiesi Clinical Trial Site 840282

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63123

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanna Nowacka-Apiyo, MD

Facility Name

Chiesi Clinical Trial Site 840123

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840142

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840273

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840281

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68506

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Antonina Gawlik, MD

Facility Name

Chiesi Clinical Trial Site 840213

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

840213

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Petr Kopecky, MD

Facility Name

Chiesi Clinical Trial Site 840128

City

Bronx

State/Province

New York

ZIP/Postal Code

10455

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840215

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaroslav Mares, MD

Facility Name

Chiesi Clinical Trial Site 840158

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28277

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840236

City

Huntersville

State/Province

North Carolina

ZIP/Postal Code

28078

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Csilla Szabo, MD

Facility Name

Chiesi Clinical Trial Site 840259

City

Monroe

State/Province

North Carolina

ZIP/Postal Code

28112

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840194

City

New Bern

State/Province

North Carolina

ZIP/Postal Code

28562

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sotir Sotirov, MD

Facility Name

Chiesi Clinical Trial Site 840120

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Individual Site Status

Withdrawn

Facility Name

Chiesi Clinical Trial Site 840112

City

Rocky Mount

State/Province

North Carolina

ZIP/Postal Code

27804

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840135

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ernesto Diaz, MD

Facility Name

Chiesi Clinical Trial Site 840189

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28403

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840104

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45231

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nabil Andrawis, MD

Facility Name

Chiesi Clinical Trial Site 840124

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Ojile, MD

Facility Name

Chiesi Clinical Trial Site 840233

City

Maumee

State/Province

Ohio

ZIP/Postal Code

43537

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840157

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43617

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840203

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Krasimir Donchev, MD

Facility Name

Chiesi Clinical Trial Site 840156

City

Jenkintown

State/Province

Pennsylvania

ZIP/Postal Code

19046

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840222

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840130

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eduardo Andre, MD

Facility Name

Chiesi Clinical Trial Site 840211

City

Fort Mill

State/Province

South Carolina

ZIP/Postal Code

29707

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Milan Kasl, MD

Facility Name

Chiesi Clinical Trial Site 840182

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29340

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840111

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840100

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Francisco Rosas, MD

Facility Name

Chiesi Clinical Trial Site 840106

City

Union

State/Province

South Carolina

ZIP/Postal Code

29379

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840167

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840306

City

Johnson City

State/Province

Tennessee

ZIP/Postal Code

37601

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lukasz Golinski, MD

Facility Name

Chiesi Clinical Trial Site 840171

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840271

City

Tullahoma

State/Province

Tennessee

ZIP/Postal Code

37388

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840101

City

Baytown

State/Province

Texas

ZIP/Postal Code

77521

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840114

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840146

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840284

City

Houston

State/Province

Texas

ZIP/Postal Code

77008

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jacek Stachera, MD

Facility Name

Chiesi Clinical Trial Site 840102

City

Katy

State/Province

Texas

ZIP/Postal Code

77494

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840274

City

Katy

State/Province

Texas

ZIP/Postal Code

77494

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840119

City

McKinney

State/Province

Texas

ZIP/Postal Code

75069

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fred Grynberg, MD

Facility Name

Chiesi Clinical Trial Site 840176

City

North Richland Hills

State/Province

Texas

ZIP/Postal Code

76180

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ivo Iliev, MD

Facility Name

Chiesi Clinical Trial Site 840191

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78063

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840231

City

Sherman

State/Province

Texas

ZIP/Postal Code

75092

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840221

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840139

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840264

City

Manassas

State/Province

Virginia

ZIP/Postal Code

20110

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840159

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23219

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 840201

City

Morgantown

State/Province

West Virginia

ZIP/Postal Code

26505

Country

United States

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 032115

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

1056ABJ

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jeffrey Tillinghast, MD

Facility Name

Chiesi Clinical Trial Site 032113

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

1426

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramon Leon, MD

Facility Name

Chiesi Clinical Trial Site 032107

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

B1837

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Humberto Cruz, MD

Facility Name

Chiesi Clinical Trial Site 032112

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

C1426ABO

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Craig Laforce, MD

Facility Name

Chiesi Clinical Trial Site 032121

City

Ciudad Autonoma de Buenos Aire

State/Province

Buenos Aires

ZIP/Postal Code

Cl425DTG

Country

Argentina

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Robert Hannum, MD

Facility Name

Chiesi Clinical Trial Site 032110

City

Florencio Varela

State/Province

Buenos Aires

ZIP/Postal Code

B1853AIK

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Fuentes, MD

Facility Name

Chiesi Clinical Trial Site 032108

City

La Plata

State/Province

Buenos Aires

ZIP/Postal Code

1900

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Luis De La Cruz, MD

Facility Name

Chiesi Clinical Trial Site 032118

City

Mar Del Plata

State/Province

Buenos Aires

ZIP/Postal Code

3168

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Bernard, MD

Facility Name

Chiesi Clinical Trial Site 032114

City

Mar Del Plata

State/Province

Buenos Aires

ZIP/Postal Code

B7600FZO

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Roberto Sotolongo, MD

Facility Name

Chiesi Clinical Trial Site 032102

City

Monte Grande

State/Province

Buenos Aires

ZIP/Postal Code

1842

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Syed Ahmed, MD

Facility Name

Chiesi Clinical Trial Site 032106

City

Quilmes

State/Province

Buenos Aires

ZIP/Postal Code

B1878FNR

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shari Anne Brazinsky, MD

Facility Name

Chiesi Clinical Trial Site 032116

City

San Fernando

State/Province

Buenos Aires

ZIP/Postal Code

1646

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brian Zeno, MD

Facility Name

Chiesi Clinical Trial Site 032100

City

Vicente López

State/Province

Buenos Aires

ZIP/Postal Code

1602

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Michael Denenberg, MD

Facility Name

Chiesi Clinical Trial Site 032111

City

Córdoba

State/Province

Cordoba

ZIP/Postal Code

X5008HHW

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shahrukh Kureishy, MD

Facility Name

Chiesi Clinical Trial Site 032120

City

Concepción Del Uruguay

State/Province

Entre Rios

ZIP/Postal Code

E3260EPD

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Gregory Feldman, MD

Facility Name

Chiesi Clinical Trial Site 032101

City

Rosario

State/Province

Santa Fe

ZIP/Postal Code

2000

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Haider Afzal, MD

Facility Name

Chiesi Clinical Trial Site 032117

City

Tucumán

State/Province

Tucuman

ZIP/Postal Code

T4000

Country

Argentina

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mahmood Ali, MD

Facility Name

Chiesi Clinical Trial Site 032103

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

1430

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Bernstein, MD

Facility Name

Chiesi Clinical Trial Site 032109

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

B1602DOH

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Priyank Desai, MD

Facility Name

Chiesi Clinical Trial Site 032105

City

Mendoza

ZIP/Postal Code

5500

Country

Argentina

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joseph Boscia, MD

Facility Name

Chiesi Clinical Trial Site 100125

City

Gabrovo

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100109

City

Haskovo

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100129

City

Kozloduy

ZIP/Postal Code

3320

Country

Bulgaria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Evelyne Davidson, MD

Facility Name

Chiesi Clinical Trial Site 100111

City

Lovech

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100115

City

Montana

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100101

City

Pleven

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100102

City

Plovdiv

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100126

City

Plovdiv

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100128

City

Razgrad

ZIP/Postal Code

7200

Country

Bulgaria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Melanie Hoppers, MD

Facility Name

Chiesi Clinical Trial Site 100104

City

Ruse

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100113

City

Ruse

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100100

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100110

City

Sofia

Country

Bulgaria

Individual Site Status

Terminated

Facility Name

Chiesi Clinical Trial Site 100112

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100116

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100117

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100118

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100119

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100121

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100123

City

Sofia

Country

Bulgaria

Individual Site Status

Terminated

Facility Name

Chiesi Clinical Trial Site 100124

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100127

City

Sofia

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100103

City

Stara Zagora

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100107

City

Stara Zagora

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100130

City

Varna

ZIP/Postal Code

9020

Country

Bulgaria

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ryan Klein, MD

Facility Name

Chiesi Clinical Trial Site 100122

City

Veliko Tarnovo

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100106

City

Vidin

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 100114

City

Vidin

Country

Bulgaria

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203101

City

Brandýs Nad Labem

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203107

City

Jindřichův Hradec

Country

Czechia

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 203109

City

Miroslav

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203114

City

Praha

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203112

City

Rokycany

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203108

City

Strakonice

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203104

City

Teplice

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203105

City

Tábor

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 203110

City

Varnsdorf

Country

Czechia

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348121

City

Komló

State/Province

ZIP/Postal Code

7300

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ward Paine, MD

Facility Name

Chiesi Clinical Trial Site 348122

City

Pécs

State/Province

ZIP/Postal Code

7626

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jorge Paoli-Bruno, MD

Facility Name

Chiesi Clinical Trial Site 348108

City

Szarvas

State/Province

Bekes

Country

Hungary

Individual Site Status

Withdrawn

Facility Name

Chiesi Clinical Trial Site 348124

City

Csorna

State/Province

ZIP/Postal Code

9300

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Smiley, MD

Facility Name

Chiesi Clinical Trial Site 348126

City

Szolnok

State/Province

ZIP/Postal Code

5000

Country

Hungary

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mercedes Ponce de Leon, MD

Facility Name

Chiesi Clinical Trial Site 348107

City

Balassagyarmat

State/Province

Nograd

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348120

City

Gödöllő

State/Province

Pest

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348104

City

Nyiregyhaza

State/Province

Szabolcs-Szatmar-Bereg

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348109

City

Nyiregyhaza

State/Province

Szabolcs-Szatmár-Bereg

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348105

City

Szombathely

State/Province

Vas

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348112

City

Hajdúnánás

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348116

City

Hatvan

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 348103

City

Monor

Country

Hungary

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 484110

City

Tijuana

State/Province

Baja California

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484108

City

Ciudad de mexico

State/Province

Cdmx

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484103

City

Cuauhtémoc

State/Province

Cdmx

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484100

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484102

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484104

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484106

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484112

City

Guadalajara

State/Province

Jalisco

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 484107

City

Morelia

State/Province

Michoacan

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484101

City

Monterrey

State/Province

Nuevo Leon

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484111

City

Monterrey

State/Province

Nuevo Leon

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484105

City

Chihuahua

Country

Mexico

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 484109

City

Chihuahua

Country

Mexico

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616119

City

Białystok

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616100

City

Gizycko

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616113

City

Grudziądz

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joanna Nowacka-Apiyo

Facility Name

Chiesi Clinical Trial Site 616116

City

Katowice

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616122

City

Kraków

ZIP/Postal Code

30-149

Country

Poland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Nidal Morrar, MD

Facility Name

Chiesi Clinical Trial Site 616106

City

Kraków

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616109

City

Kraków

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616118

City

Kraków

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616117

City

Ostrowiec

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616105

City

Ostróda

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616123

City

Poznań

ZIP/Postal Code

60-214

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Awawu Igbinadolor, MD

Facility Name

Chiesi Clinical Trial Site 616107

City

Poznań

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616110

City

Poznań

Country

Poland

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 616108

City

Rzeszów

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616114

City

Skierniewice

Country

Poland

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 616120

City

Skorzewo

ZIP/Postal Code

60-185

Country

Poland

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Basilio Garcia Sellek, MD

Facility Name

Chiesi Clinical Trial Site 616102

City

Sosnowiec

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616111

City

Tarnów

Country

Poland

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 616115

City

Toruń

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616104

City

Wrocław

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616112

City

Wrocław

Country

Poland

Individual Site Status

Not yet recruiting

Facility Name

Chiesi Clinical Trial Site 616101

City

Zawadzkie

Country

Poland

Individual Site Status

Recruiting

Facility Name

Chiesi Clinical Trial Site 616103

City

Łódź

Country

Poland

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

Plan to Share IPD

Citations:

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Citation

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17132052

Citation

Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442.

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19818867

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Montes de Oca M, Perez-Padilla R, Talamo C, Halbert RJ, Moreno D, Lopez MV, Muino A, Jose Roberto BJ, Valdivia G, Pertuze J, Ana Maria BM; PLATINO Team. Acute bronchodilator responsiveness in subjects with and without airflow obstruction in five Latin American cities: the PLATINO study. Pulm Pharmacol Ther. 2010 Feb;23(1):29-35. doi: 10.1016/j.pupt.2009.09.005. Epub 2009 Oct 8.

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10377201

Citation

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19720809

Citation

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29668352

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Links:

URL

https://goldcopd.org/gold-reports/

Description

Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease (2020 Report)

URL

https://www.ema.europa.eu/en/documents/scientific-guideline/draft-ich-e9-r1-addendum-estimands-sensitivity-analysis-clinical-trials-guideline-statistical_en.pdf

Description

ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials

URL

http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/copd.php

Description

COPD Assessment Test (CAT)

URL

https://www.verywellhealth.com/guidelines-for-the-mmrc-dyspnea-scale-914740

Description

Measuring shortness of breath (dyspnea) in COPD.

Learn more about this trial

A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD

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A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

COPD, COPD Exacerbation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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