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A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid (FORCE2)

Primary Purpose

Asthma

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Beclomethasone Dipropionate/Formoterol Fumarate
Beclomethasone Dipropionate
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Beclomethasone Dipropionate, Beclometasone dipropionate/Formoterol fumarate, Inhaled Corticosteroids

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures.
  2. Sex and age: Male or female aged ≥18 and ≤75 years.
  3. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40
  4. Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening).
  5. Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening.
  6. Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 > 12% and > 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol HFA pMDI 90µg/actuation. Note: In case the reversibility threshold is not met at screening, the test can be performed once before randomization.
  7. Female subjects:

    a. WOCBP fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case).

    b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges).

  8. Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter.

Exclusion Criteria:

  1. Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization).
  2. Poor compliance with run-in medication or eDiary completion <50% before randomization.
  3. History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk.
  4. Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period.
  5. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening.
  6. Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation.
  7. Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening.
  8. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, COPD (as defined by the current GOLD Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations.
  9. Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit.
  10. E-cigarette status: Current e-cigarettes users at the time of the screening visit.
  11. Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana).
  12. Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening.
  13. Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate <100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment.
  14. ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF >450ms for males or QTcF >470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation).
  15. Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
  16. Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.
  17. Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated.
  18. Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients.
  19. Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study.
  20. Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation.
  21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants.
  22. Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening.
  23. Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion.
  24. Participating in other investigational trial: Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial.
  25. Spacer: The need to use a spacer for correct self-administration of a pMDI.

Sites / Locations

  • Chiesi Clinical Trial Site 840858
  • Chiesi Clinical Trial Site 840895
  • Chiesi Clinical Trial Site 840856Recruiting
  • Chiesi Clinical Trial Site 840843Recruiting
  • Chiesi Clinical Trial Site 840860Recruiting
  • Chiesi Clinical Trial Site 840896
  • Chiesi Clinical Trial Site 840883Recruiting
  • Chiesi Clinical Trial Site 840810Recruiting
  • Chiesi Clinical Trial Site 840869
  • Chiesi Clinical Trial Site 840890
  • Chiesi Clinical Trial Site 840808Recruiting
  • Chiesi Clinical Trial Site 840879
  • Chiesi Clinical Trial Site 840868Recruiting
  • Chiesi Clinical Trial Site 840849
  • Chiesi Clinical Trial Site 840877Recruiting
  • Chiesi Clinical Trial Site 840861Recruiting
  • Chiesi Clinical Trial Site 840881
  • Chiesi Clinical Trial Site 840873Recruiting
  • Chiesi Clinical Trial Site 840800Recruiting
  • Chiesi Clinical Trial Site 840820
  • Chiesi Clinical Trial Site 840841Recruiting
  • Chiesi Clinical Trial Site 840817Recruiting
  • Chiesi Clinical Trial Site 840822Recruiting
  • Chiesi Clinical Trial Site 840838
  • Chiesi Clinical Trial Site 840864
  • Chiesi Clinical Trial Site 840809Recruiting
  • Chiesi Clinical Trial Site 840863Recruiting
  • Chiesi Clinical Trial Site 840865Recruiting
  • Chiesi Clinical Trial Site 840831
  • Chiesi Clinical Trial Site 840814Recruiting
  • Chiesi Clinical Trial Site 840819Recruiting
  • Chiesi Clinical Trial Site 840875Recruiting
  • Chiesi Clinical Trial Site 840887
  • Chiesi Clinical Trial Site 840848
  • Chiesi Clinical Trial Site 840821Recruiting
  • Chiesi Clinical Trial Site 840829Recruiting
  • Chiesi Clinical Trial Site 840828Recruiting
  • Chiesi Clinical Trial Site 840847
  • Chiesi Clinical Trial Site 840818Recruiting
  • Chiesi Clinical Trial Site 840802Recruiting
  • Chiesi Clinical Trial Site 840835Recruiting
  • Chiesi Clinical Trial Site 840806Recruiting
  • Chiesi Clinical Trial Site 840855Recruiting
  • Chiesi Clinical Trial Site 840839Recruiting
  • Chiesi Clinical Trial Site 840840Recruiting
  • Chiesi Clinical Trial Site 840827
  • Chiesi Clinical Trial Site 840811Recruiting
  • Chiesi Clinical Trial Site 840889
  • Chiesi Clinical Trial Site 840834
  • Chiesi Clinical Trial Site 840880Recruiting
  • Chiesi Clinical Trial Site 840813
  • Chiesi Clinical Trial Site 840807Recruiting
  • Chiesi Clinical Trial Site 840871Recruiting
  • Chiesi Clinical Trial Site 840854
  • Chiesi Clinical Trial Site 840805
  • Chiesi Clinical Trial Site 840824Recruiting
  • Chiesi Clinical Trial Site 840826Recruiting
  • Chiesi Clinical Trial Site 840859
  • Chiesi Clinical Trial Site 840888
  • Chiesi Clinical Trial Site 840846Recruiting
  • Chiesi Clinical Trial Site 840867Recruiting
  • Chiesi Clinical Trial Site 840897
  • Chiesi Clinical Trial Site 840872Recruiting
  • Chiesi Clinical Trial Site 840836
  • Chiesi Clinical Trial Site 840851
  • Chiesi Clinical Trial Site 840852Recruiting
  • Chiesi Clinical Trial Site 840804
  • Chiesi Clinical Trial Site 840866Recruiting
  • Chiesi Clinical Trial Site 840878Recruiting
  • Chiesi Clinical Trial Site 840884
  • Chiesi Clinical Trial Site 840830
  • Chiesi Clinical Trial Site 840853Recruiting
  • Chiesi Clinical Trial Site 840885
  • Chiesi Clinical Trial Site 840892
  • Chiesi Clinical Trial Site 840844
  • Chiesi Clinical Trial Site 840850
  • Chiesi Clinical Trial Site 840894
  • Chiesi Clinical Trial Site 840891
  • Chiesi Clinical Trial Site 840812Recruiting
  • Chiesi Clinical Trial Site 840815
  • Chiesi Clinical Trial Site 840874Recruiting
  • Chiesi Clinical Trial Site 840845Recruiting
  • Chiesi Clinical Trial Site 840876Recruiting
  • Chiesi Clinical Trial Site 840803Recruiting
  • Chiesi Clinical Trial Site 840825
  • Chiesi Clinical Trial Site 840833
  • Chiesi Clinical Trial Site 840862Recruiting
  • Chiesi Clinical Trial Site 840816
  • Chiesi Clinical Trial Site 840842
  • Chiesi Clinical Trial Site 840857
  • Chiesi Clinical Trial Site 840823
  • Chiesi Clinical Trial Site 840801
  • Chiesi Clinical Trial Site 840893
  • Chiesi Clinical Trial Site 840837
  • Chiesi Clinical Trial Site 840882
  • Chiesi Clinical Trial Site 840870Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHF 1535 pMDI

CHF 718 pMDI

Arm Description

CHF 1535 pMDI 800/24µg TDD

CHF 718 pMDI 800µg TDD

Outcomes

Primary Outcome Measures

Change from baseline in FEV1 Area Under the Curve from 0 to 12 hours post-dose (AUC0-12h) at Week 12 calculated as the difference of the values for CHF 1535 pMDI 800/24µg total daily dose (TDD) and CHF 718 pMDI 800µg TDD.

Secondary Outcome Measures

Change from baseline in peak FEV1 within the first 3 hours post-dose at Week 12 calculated as the difference of the values for CHF 1535 pMDI 800/24µg TDD and CHF 718 pMDI 800µg TDD.

Full Information

First Posted
March 4, 2022
Last Updated
February 7, 2023
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05292586
Brief Title
A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
Acronym
FORCE2
Official Title
A 12 Week, Randomized, Double-blind, Multicenter, Active Controlled, 2-Arm Parallel Group Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose (Fixed Combination of Extrafine Beclomethasone Dipropionate Plus Formoterol Fumarate) Compared to CHF 718 pMDI 800µg Total Daily Dose (Extrafine Beclomethasone Dipropionate) in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (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
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the superiority of CHF 1535 compared to CHF 718 in subjects with asthma on medium or high dose inhaled corticosteroids.
Detailed Description
This is a phase III, multicenter, randomized, double-blind active controlled 2-arm parallel group to compare superiority of CHF 1535 pMDI compared to CHF 718 pMDI in terms of change from baseline in FEV1 AUC0-12h at Week 12. After screening, eligible subjects will enter a 2-week run-in period using CHF 718 (BDP) pMDI 100µg, followed by a 12-week double-blind, treatment period. Screened subjects who were on a medium dose ICS or medium dose ICS-LABA prior to the study will be put on CHF 718 pMDI 100µg 2 inhalations BID (TDD 400µg) during the 2-week run in period. Screened subjects who were on a high dose ICS prior to the study will be put on CHF 718 pMDI 100µg 4 inhalations BID (TDD 800µg) during the 2-week run in period. Following the run-in period, eligible subjects will be randomized to one of two study drug arms (using a 1:1 allocation ratio) for 12 weeks. A total of 6 clinic visits (V0- V5) and a follow-up call (V6) will be performed during the study. 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, and adverse events will be assessed and recorded throughout the study. At study visits, subjects will undergo vital signs, physical exam, 12-lead ECG, PEF, and spirometry measurements, including serial spirometry at V2 and V5. Symptoms 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
Asthma
Keywords
Asthma, Beclomethasone Dipropionate, Beclometasone dipropionate/Formoterol fumarate, Inhaled Corticosteroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHF 1535 pMDI
Arm Type
Experimental
Arm Description
CHF 1535 pMDI 800/24µg TDD
Arm Title
CHF 718 pMDI
Arm Type
Active Comparator
Arm Description
CHF 718 pMDI 800µg TDD
Intervention Type
Drug
Intervention Name(s)
Beclomethasone Dipropionate/Formoterol Fumarate
Other Intervention Name(s)
BDP/FF
Intervention Description
Available in pressurized inhalation solution BDP/FF 200/6 µg
Intervention Type
Drug
Intervention Name(s)
Beclomethasone Dipropionate
Other Intervention Name(s)
BDP
Intervention Description
Available in pressurized inhalation solution BDP 100 µg
Primary Outcome Measure Information:
Title
Change from baseline in FEV1 Area Under the Curve from 0 to 12 hours post-dose (AUC0-12h) at Week 12 calculated as the difference of the values for CHF 1535 pMDI 800/24µg total daily dose (TDD) and CHF 718 pMDI 800µg TDD.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change from baseline in peak FEV1 within the first 3 hours post-dose at Week 12 calculated as the difference of the values for CHF 1535 pMDI 800/24µg TDD and CHF 718 pMDI 800µg TDD.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent: A signed and dated written informed consent obtained prior to any study-related procedures. Sex and age: Male or female aged ≥18 and ≤75 years. Diagnosis of asthma: A documented history of asthma for at least 1 year, with onset before age 40 Stable asthma therapy: Use of medium-dose ICS with or without a LABA or high-dose ICS alone for 3 months (at a stable dose for at least 4 weeks prior to screening). Lung function: Subjects with a pre-bronchodilator FEV1 ≥40% and ≤85% of predicted, after appropriate washout from bronchodilators, at the screening and randomization visits. In addition, the absolute value of the first pre-dose FEV1 at randomization (V2) must be at least 80% of the pre-bronchodilator value attained at screening. Reversibility post-bronchodilator: Subjects with a positive reversibility to bronchodilator at screening, defined as an increase in FEV1 > 12% and > 200mL compared to baseline within 30 minutes after 4 inhalations of albuterol HFA pMDI 90µg/actuation. Note: In case the reversibility threshold is not met at screening, the test can be performed once before randomization. Female subjects: a. WOCBP fulfilling one of the following criteria: i. WOCBP with fertile male partners: they and/or their partner must be willing to use a highly effective birth control method from the signing of the informed consent form and until the follow-up contact or ii. WOCBP with non-fertile male partners (contraception is not required in this case). b. Female subjects of non-childbearing potential defined as physiologically incapable of becoming pregnant (i.e. post-menopausal or permanently sterile as per definitions given in Appendix 2). Tubal ligation or partial surgical interventions are not acceptable. If indicated, as per investigator's request, post-menopausal status may be confirmed by follicle-stimulating hormone levels (according to local laboratory ranges). Cooperative attitude and ability to demonstrate correct use of the pMDI inhalers and eDiary/peak flow meter. Exclusion Criteria: Pregnancy or lactation: where pregnancy is defined as the state of a female after conception and until termination of the gestation, confirmed by a positive pregnancy test (serum and urine pregnancy test to be performed at screening visit and urine pregnancy test to be performed prior to randomization). Poor compliance with run-in medication or eDiary completion <50% before randomization. History of "at risk" asthma: History of near-fatal asthma or of a past hospitalization for asthma in intensive care unit which, in the judgement of the investigator, may place the subject at undue risk. Recent asthma exacerbation: Hospitalization, emergency room admission or use of systemic corticosteroids for an asthma exacerbation in the 4 weeks prior to screening visit or during the run-in period. Unresolved respiratory tract infection (RTI) in the 4 weeks prior to the screening visit or during run-in period. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 8 weeks or complications from this disease, which have not resolved within 14 days prior to screening. Unstable ICS dose during the 4 weeks prior to screening visit, including any change in dose, schedule, or formulation. Use of systemic corticosteroid medication in the 4 weeks prior to screening or slow-release corticosteroids in the 12 weeks before screening. Respiratory disorders other than asthma: History of a diagnosis of cystic fibrosis, bronchiectasis, COPD (as defined by the current GOLD Report), alpha-1 antitrypsin deficiency, or any other significant lung disease which may interfere with study evaluations. Smoking status: Current smokers or ex-smokers with total cumulative exposure equal to or more than 10 pack-years or having stopped smoking within one year prior to screening visit. E-cigarette status: Current e-cigarettes users at the time of the screening visit. Cannabis usage: Current use of inhaled or oral cannabis products (e.g. marijuana). Substance abuse: Subjects with a history of alcohol or substance/drug abuse within 12 months prior to screening. Cardiovascular diseases: Subjects who have clinically significant cardiovascular condition such as, but not limited to, unstable ischemic heart disease, NYHA Class III/IV heart failure, acute ischemic heart disease within one year prior to study entry, known history of atrial fibrillation or history of sustained and non-sustained cardiac arrhythmias diagnosed within the last 6 months prior to screening, not controlled with a rate control strategy. Note: Subjects with Permanent Atrial Fibrillation (for at least 6 months) with a resting ventricular rate <100/min, controlled with a rate control strategy (i.e., selective β-blocker, calcium channel blocker, pacemaker placement, digoxin, or ablation therapy) can be considered for the enrollment. ECG criteria: An abnormal and clinically significant 12-lead electrocardiogram (ECG) which may impact the safety of the subject according to Investigator's judgement. In terms of the QTcF, subjects with QTcF >450ms for males or QTcF >470ms for females at screening or at randomization visits (criterion not applicable for subject with pacemaker or permanent atrial fibrillation). Other medical conditions: Other active severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. Vaccination: Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period. Subjects' wellbeing: Subjects mentally or legally incapacitated, including but not limited to subjects who are institutionalized or incarcerated. Hypersensitivity: Subjects with known intolerance, hypersensitivity or contraindication to treatment with ß2-agonists, ICS, or propellant gases/excipients. Surgery: Subjects with major surgery in the 3 months prior to the screening visit or planned surgery during the study. Additional treatment: Subjects treated with non-potassium sparing diuretics (unless administered as a fixed-dose combination with a potassium conserving drug or changed to potassium sparing before the screening), non-selective beta-blocking drugs, quinidine, quinidine-like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic antidepressants. Subjects with concomitant immunosuppressive therapy, use of oral or injected corticosteroids, anti-IgE, anti-IL5 or other monoclonal or polyclonal antibodies within 12 weeks prior to screening. Subjects who are receiving any therapy that could interfere with the study drugs according to investigator's opinion. Participating in other investigational trial: Subjects who have received an investigational drug within 1 month or 5 half-lives (whichever is greater) prior to screening visit, or have been previously randomized in this trial, or are currently participating in another clinical trial. Spacer: The need to use a spacer for correct self-administration of a pMDI.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chiesi Clinical Trial Info
Phone
+39 0521 2791
Email
clinicaltrials_info@chiesi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven F. Weinstein, M.D.
Organizational Affiliation
Allergy and Asthma Specialists Medical Group and Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiesi Clinical Trial Site 840858
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lawrence Sindel, MD
Facility Name
Chiesi Clinical Trial Site 840895
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muhammad Salim, MD
Facility Name
Chiesi Clinical Trial Site 840856
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Warren Pleskow, MD
Facility Name
Chiesi Clinical Trial Site 840843
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robby Ayoub, MD
Facility Name
Chiesi Clinical Trial Site 840860
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Weinstein, MD
Facility Name
Chiesi Clinical Trial Site 840896
City
Long Beach
State/Province
California
ZIP/Postal Code
90805
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vellore Bhupathy, MD
Facility Name
Chiesi Clinical Trial Site 840883
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Tan, MD
Facility Name
Chiesi Clinical Trial Site 840810
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Wachtel, MD
Facility Name
Chiesi Clinical Trial Site 840869
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ryan Klein, MD
Facility Name
Chiesi Clinical Trial Site 840890
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Chang, MD
Facility Name
Chiesi Clinical Trial Site 840808
City
Northridge
State/Province
California
ZIP/Postal Code
91324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Vadgama, MD
Facility Name
Chiesi Clinical Trial Site 840879
City
Pomona
State/Province
California
ZIP/Postal Code
91768
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mallu Reddy, MD
Facility Name
Chiesi Clinical Trial Site 840868
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Jordan, MD
Facility Name
Chiesi Clinical Trial Site 840849
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shari Brazinsky, MD
Facility Name
Chiesi Clinical Trial Site 840877
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Greiner, MD
Facility Name
Chiesi Clinical Trial Site 840861
City
San Jose
State/Province
California
ZIP/Postal Code
95117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Wolfe, MD
Facility Name
Chiesi Clinical Trial Site 840881
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Pham, MD
Facility Name
Chiesi Clinical Trial Site 840873
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Soteres, MD
Facility Name
Chiesi Clinical Trial Site 840800
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaila Gogate, MD
Facility Name
Chiesi Clinical Trial Site 840820
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
Jose Pinero, MD
Facility Name
Chiesi Clinical Trial Site 840841
City
Cutler Bay
State/Province
Florida
ZIP/Postal Code
33189
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miguel Mujica-Baella, MD
Facility Name
Chiesi Clinical Trial Site 840817
City
Greenacres City
State/Province
Florida
ZIP/Postal Code
33467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose G Cevallos Yepez, MD
Facility Name
Chiesi Clinical Trial Site 840822
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
Alberto Manzor, MD
Facility Name
Chiesi Clinical Trial Site 840838
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pastor Torres, MD
Facility Name
Chiesi Clinical Trial Site 840864
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34746
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fortune Alabi, MD
Facility Name
Chiesi Clinical Trial Site 840809
City
Miami Gardens
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Vasquez, MD
Facility Name
Chiesi Clinical Trial Site 840863
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Idalia Acosta, MD
Facility Name
Chiesi Clinical Trial Site 840865
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Alvarez, MD
Facility Name
Chiesi Clinical Trial Site 840831
City
Miami Springs
State/Province
Florida
ZIP/Postal Code
33166
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Terrelonge, MD
Facility Name
Chiesi Clinical Trial Site 840814
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
Ibrahim Menendez Perez, MD
Facility Name
Chiesi Clinical Trial Site 840819
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yamirka Duardo-Guerra, MD
Facility Name
Chiesi Clinical Trial Site 840875
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilia Ables, MD
Facility Name
Chiesi Clinical Trial Site 840887
City
Miami
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
Carlos Perez, MD
Facility Name
Chiesi Clinical Trial Site 840848
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
Ana Acosta, MD
Facility Name
Chiesi Clinical Trial Site 840821
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adonis Maiquez, MD
Facility Name
Chiesi Clinical Trial Site 840829
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
Barbara Orozco Perez, MD
Facility Name
Chiesi Clinical Trial Site 840828
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
Lazaro Nunez, MD
Facility Name
Chiesi Clinical Trial Site 840847
City
Miami
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Acosta, MD
Facility Name
Chiesi Clinical Trial Site 840818
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
Luis De Armas, MD
Facility Name
Chiesi Clinical Trial Site 840802
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Daniel, MD
Facility Name
Chiesi Clinical Trial Site 840835
City
Miami
State/Province
Florida
ZIP/Postal Code
33184
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alejandro De La Cruz, MD
Facility Name
Chiesi Clinical Trial Site 840806
City
Miami
State/Province
Florida
ZIP/Postal Code
33185
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Jimenez, MD
Facility Name
Chiesi Clinical Trial Site 840855
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Paoli-Bruno, MD
Facility Name
Chiesi Clinical Trial Site 840839
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
Ramon Leon, MD
Facility Name
Chiesi Clinical Trial Site 840840
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
Jaynier Moya, MD
Facility Name
Chiesi Clinical Trial Site 840827
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33029
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alvaro Murcia, MD
Facility Name
Chiesi Clinical Trial Site 840811
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yohanna Deno, MD
Facility Name
Chiesi Clinical Trial Site 840889
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33707
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohamed I Ali, MD
Facility Name
Chiesi Clinical Trial Site 840834
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
Howard Chipman, MD
Facility Name
Chiesi Clinical Trial Site 840880
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33713
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fadi Saba, MD
Facility Name
Chiesi Clinical Trial Site 840813
City
Sweetwater
State/Province
Florida
ZIP/Postal Code
33172
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ana Elosegui, MD
Facility Name
Chiesi Clinical Trial Site 840807
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronald Saff, MD
Facility Name
Chiesi Clinical Trial Site 840871
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
John Trimble, MD
Facility Name
Chiesi Clinical Trial Site 840854
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60026
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giselle Mosnaim, MD
Facility Name
Chiesi Clinical Trial Site 840805
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Coggi, MD
Facility Name
Chiesi Clinical Trial Site 840824
City
White Marsh
State/Province
Maryland
ZIP/Postal Code
21162
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Matz, MD
Facility Name
Chiesi Clinical Trial Site 840826
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Miller, MD
Facility Name
Chiesi Clinical Trial Site 840859
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Vandewalker, MD
Facility Name
Chiesi Clinical Trial Site 840888
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Siler, MD
Facility Name
Chiesi Clinical Trial Site 840846
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Tillinghast, MD
Facility Name
Chiesi Clinical Trial Site 840867
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Ford, MD
Facility Name
Chiesi Clinical Trial Site 840897
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vikas Sayal, MD
Facility Name
Chiesi Clinical Trial Site 840872
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alton Walters, MD
Facility Name
Chiesi Clinical Trial Site 840836
City
Brick
State/Province
New Jersey
ZIP/Postal Code
08724
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruce DeCotiis, MD
Facility Name
Chiesi Clinical Trial Site 840851
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Dorf, MD
Facility Name
Chiesi Clinical Trial Site 840852
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Craig Fred Laforce, MD
Facility Name
Chiesi Clinical Trial Site 840804
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Bernstein, MD
Facility Name
Chiesi Clinical Trial Site 840866
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeremy Cole, MD
Facility Name
Chiesi Clinical Trial Site 840878
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hassan Abouhouli, MD
Facility Name
Chiesi Clinical Trial Site 840884
City
Grants Pass
State/Province
Oregon
ZIP/Postal Code
97527
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Delgado, MD
Facility Name
Chiesi Clinical Trial Site 840830
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
Sarah Smiley, MD
Facility Name
Chiesi Clinical Trial Site 840853
City
Portland
State/Province
Oregon
ZIP/Postal Code
97202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Montanaro, MD
Facility Name
Chiesi Clinical Trial Site 840885
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Zwetchkenbaum, MD
Facility Name
Chiesi Clinical Trial Site 840892
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles Thompson, MD
Facility Name
Chiesi Clinical Trial Site 840844
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
Gregory Feldman, MD
Facility Name
Chiesi Clinical Trial Site 840850
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis De La Cruz, MD
Facility Name
Chiesi Clinical Trial Site 840894
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Denenberg, MD
Facility Name
Chiesi Clinical Trial Site 840891
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Farhan Siddiqui, MD
Facility Name
Chiesi Clinical Trial Site 840812
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelyn Davidson, MD
Facility Name
Chiesi Clinical Trial Site 840815
City
Baytown
State/Province
Texas
ZIP/Postal Code
77521
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haider Afzal, MD
Facility Name
Chiesi Clinical Trial Site 840874
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Fuentes, MD
Facility Name
Chiesi Clinical Trial Site 840845
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John M Joseph, MD
Facility Name
Chiesi Clinical Trial Site 840876
City
Dallas
State/Province
Texas
ZIP/Postal Code
75225
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Baxter, MD
Facility Name
Chiesi Clinical Trial Site 840803
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd Funkhouser, MD
Facility Name
Chiesi Clinical Trial Site 840825
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
Jose Melendez, MD
Facility Name
Chiesi Clinical Trial Site 840833
City
Houston
State/Province
Texas
ZIP/Postal Code
77094
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chinelo Okoye, MD
Facility Name
Chiesi Clinical Trial Site 840862
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
Shahrukh Kureishy, MD
Facility Name
Chiesi Clinical Trial Site 840816
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shakil Ahmed, MD
Facility Name
Chiesi Clinical Trial Site 840842
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Vidouria, MD
Facility Name
Chiesi Clinical Trial Site 840857
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lionel Reyes, MD
Facility Name
Chiesi Clinical Trial Site 840823
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Marks, MD
Facility Name
Chiesi Clinical Trial Site 840801
City
Sugar Land
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harish Thakkar, MD
Facility Name
Chiesi Clinical Trial Site 840893
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafael Firszt, MD
Facility Name
Chiesi Clinical Trial Site 840837
City
Riverton
State/Province
Utah
ZIP/Postal Code
84065
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Devenport, MD
Facility Name
Chiesi Clinical Trial Site 840882
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Elkayam, MD
Facility Name
Chiesi Clinical Trial Site 840870
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Steven, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
33329598
Citation
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Citation
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Citation
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Citation
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Citation
Chau-Etchepare F, Hoerger JL, Kuhn BT, Zeki AA, Haczku A, Louie S, Kenyon NJ, Davis CE, Schivo M. Viruses and non-allergen environmental triggers in asthma. J Investig Med. 2019 Oct;67(7):1029-1041. doi: 10.1136/jim-2019-001000. Epub 2019 Jul 27.
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Citation
GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9. Erratum In: Lancet. 2020 Nov 14;396(10262):1562.
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Citation
Forno E, Celedon JC. Asthma and ethnic minorities: socioeconomic status and beyond. Curr Opin Allergy Clin Immunol. 2009 Apr;9(2):154-60. doi: 10.1097/aci.0b013e3283292207.
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Citation
Zein JG, Udeh BL, Teague WG, Koroukian SM, Schlitz NK, Bleecker ER, Busse WB, Calhoun WJ, Castro M, Comhair SA, Fitzpatrick AM, Israel E, Wenzel SE, Holguin F, Gaston BM, Erzurum SC; Severe Asthma Research Program. Impact of Age and Sex on Outcomes and Hospital Cost of Acute Asthma in the United States, 2011-2012. PLoS One. 2016 Jun 13;11(6):e0157301. doi: 10.1371/journal.pone.0157301. eCollection 2016.
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Citation
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Citation
Davis J, Trudo F, Siddall J, Small M. Burden of asthma among patients adherent to ICS/LABA: A real-world study. J Asthma. 2019 Mar;56(3):332-340. doi: 10.1080/02770903.2018.1455858. Epub 2018 Apr 6.
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Bateman ED, Boushey HA, Bousquet J, Busse WW, Clark TJ, Pauwels RA, Pedersen SE; GOAL Investigators Group. Can guideline-defined asthma control be achieved? The Gaining Optimal Asthma ControL study. Am J Respir Crit Care Med. 2004 Oct 15;170(8):836-44. doi: 10.1164/rccm.200401-033OC. Epub 2004 Jul 15.
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Citation
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A Study Testing the Superiority of CHF 1535 pMDI 800/24µg Total Daily Dose Compared to CHF 718 pMDI 800µg Total Daily Dose in Adults With Asthma on Medium or High-Dose Inhaled Corticosteroid

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