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A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease (GLIMMER)

Primary Purpose

COPD, Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

CHF 5259

Placebo

Tiotropium Bromide 18 µg Inhalation Capsule

About this trial

This is an interventional other trial for COPD focused on measuring CHF 5259, Chronic Obstructive Pulmonary Disease (COPD), pMDI (pressurized metered dose inhaler), GLIMMER

Eligibility Criteria

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

Inclusion Criteria:

Male or female subjects aged ≥ 40 who have signed an Informed Consent Form prior to initiation of any study-related procedure.
Subjects with a diagnosis of COPD (according to GOLD 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD Report) at least 12 months before the screening visit.
Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years
A post-bronchodilator forced expiratory volume in the 1st second (FEV1) ≥50% and <80% of the predicted normal value and,
a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7 at screening and
a demonstrated reversibility to ipratropium defined as ΔFEV1 ≥ 5% over baseline 30-45 minutes after inhaling 4 puffs of ipratropium
Subjects under regular COPD therapy for at least 2 months prior to screening with either inhaled long-acting muscarinic antagonist (LAMA), inhaled ICS/ long-acting β2-agonist (LABA), inhaled ICS + LAMA
Symptomatic subjects at screening with a CAT score ≥10. This criterion must be confirmed at randomization
Symptomatic subjects with a BDI focal score ≤ 10. This criterion must be confirmed at randomization
A cooperative attitude and ability to demonstrate correct use of the inhalers and e-diary.

Exclusion Criteria:

Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use highly effective birth control methods
Diagnosis of asthma or Asthma-COPD Overlap Syndrome (ACOS) as described in global initiative for asthma (GINA) Report 2016, history of allergic rhinitis or atopy (atopy which may raise contra-indications or impact the efficacy of the study treatment according to Investigator's judgment)
COPD Exacerbations: a moderate or severe COPD exacerbation that has not resolved ≤14 days prior to screening and ≤30 days following the last dose of any oral/systemic corticosteroid or antibiotic (whichever comes last). A Moderate or Severe COPD exacerbation during the run-in period
Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening or during run-in
Subjects treated with non-cardio-selective β-blockers in the month preceding screening or during the run-in period
Subjects treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as needed
Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator's judgment.
Subjects who have clinically significant cardiovascular condition
Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement
Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females at screening visit
Medical diagnosis of narrow-angle glaucoma, clinically relevant 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-adrenergic receptor agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impact the efficacy of the study treatment according to the Investigator's judgement
Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study treatment according to Investigator's judgement
Subjects with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L) at screening
Use of potent cytochrome P450 2D6 and 3A4 inhibitors within 4 weeks prior to screening
Unstable or uncontrolled concurrent disease; fever, endocrine disease, gastrointestinal disease; neurological disease; hematological disease; autoimmune disorders, or other which may impact the feasibility of the results of the study according to Investigator's judgment
History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening
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.
Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order.
Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Active Comparator

Arm Label

Treatment A

Treatment B

Treatment C

Treatment D

Treatment E

Treatment F

Arm Description

CHF 5259 pMDI 6.25 μg, 1 inhalation twice daily (bid); (total daily dose [TDD] of CHF 5259 12.5 μg)

CHF 5259 pMDI 12.5 μg, 1 inhalation bid; (TDD of CHF 5259: 25 μg)

CHF 5259 pMDI 12.5 μg, 2 inhalations bid; (TDD of CHF 5259: 50 μg)

CHF 5259 pMDI 25 μg, 2 inhalations bid; (TDD of CHF 5259: 100 μg)

Placebo, 2 inhalations of CHF 5259 pMDI-matched Placebo bid;

Tiotropium (TIO) 18 μg, SPIRIVA® HandiHaler®, 2 inhalations once daily (od) of the content of 1 capsule; (TDD of TIO: 18 μg)

Outcomes

Primary Outcome Measures

Change From Baseline in FEV1 AUC(0-12h) Normalized by Time at Week 6

Change from baseline in FEV1 AUC(0-12h), normalized by time, at the end of treatment (Week 6). Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;

Secondary Outcome Measures

Change From Baseline in FEV1 AUC(0-12h) Normalized by Time on Day 1

Change from baseline in FEV1 AUC(0-12h), normalized by time, on Day 1. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 on Day 1 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (12 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-12h)=Mean FEV1 after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;

Change From Baseline in FEV1 AUC(0-4h) Normalized by Time on Day 1 and at Week 6

Change from baseline in FEV1 AUC(0-4h), normalized by time on Day 1 of treatment (Week 0). Spirometry, used to measure FEV1, was performed according to internationally accepted standards. The AUC for FEV1 on Day 1 and at Week 6 of treatment was calculated by using the linear trapezoidal rule, based on the changes in FEV1 from the baseline values, and divided by the observation time (4 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; FEV1 AUC(0-4h)=Mean FEV1 after inhalation, measured at prespecified times for up to 4-h observation period (0-4h), normalized by time;

Change From Baseline in FEV1 Peak(0-4h) at Day 1 and Week 6

Change from baseline in FEV1 peak(0-4h) (L) on Day 1 and at Week 6. Peak FEV1 is defined as the maximum FEV1 observed in the first 4 hours after dose of study medication. Definitions: Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second; Peak(0-4h)=Maximum FEV1 between 0 and 4 h.

Change From Baseline in FVC AUC(0-12h), Normalized by Time on Day 1 and at Week 6

Change from baseline in FVC AUC(0-12h), normalized by time, on Day 1 and at the end of treatment (Week 6). Spirometry, used to measure FVC, was performed according to internationally accepted standards. The AUC for FVC was calculated by using the linear trapezoidal rule, based on the changes in FVC from the baseline values, and divided by the observation time (4 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; FVC AUC(0-12h)=Mean FVC after inhalation, measured at prespecified times for up to 12-h observation period (0-12 h), normalized by time;

Change From Baseline in FVC AUC(0-4h) Normalized by Time on Day 1 and at Week 6

Change from baseline in FVC AUC(0-4h), normalized by time, on Day 1 and at the end of treatment (Week 6). Spirometry, used to measure FVC, was performed according to internationally accepted standards. The AUC for FVC was calculated by using the linear trapezoidal rule, based on the changes in FVC from the baseline values, and divided by the observation time (4 hours). Definitions: AUC=Area under the curve; Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; FVC AUC(0-4)=Mean FVC after inhalation, measured at prespecified times for up to 4-h observation period (0-4 h), normalized by time;

Change From Baseline in FVC Peak(0-4h) on Day 1 and at Week 6

Change from baseline in FVC peak(0-4h) (L) on Day 1 and at the end of treatment at Week 6. Peak FEV1 is defined as the maximum FEV1 observed in the first 4 hours after dose of study medication. Definitions: Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); Day 1=Day of the first dose of randomized study drug at Visit 2 (Week 0); FVC=Forced Vital Capacity; Peak(0-4h)=Maximum FEV1 between 0 and 4 h.

Time to Onset of Action (Change From Baseline in Post-dose FEV1 ≥ 100 mL) on Day 1

Time to onset of action is defined as the time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥100 mL.

Number of Patients Achieving Onset of Action - Change From Baseline in Post-dose FEV1 ≥100 mL on Day 1

Number of patients achieving onset of action was defined as a change from baseline in post-dose FEV1 ≥100 mL on Day 1. These are the patients who contributed to the results, reported as median and 95% CI for 'time to onset of action' presented in Outcome Measure 8, above.

Change From Baseline in Pre-dose Morning FEV1 at Week 3 and Week 6

Change from baseline in FEV1 at treatment visit 3 (Week 3) and treatment visit 4 (Week 6) of treatment. Spirometry, used to measure FEV1, was performed according to internationally accepted standards. Definitions: Baseline=Baseline value was the average of the pre-dose measurements (at 45 mins and 15 mins pre-dose), at Visit 2 (Week 0); FEV1=Forced expiratory volume in the 1st second;

Change From Baseline in Pre-Dose Morning Inspiratory Capacity (IC) at Week 3 and Week 6

Change from baseline in IC at treatment Visit 3 (Week 3) and treatment Visit 4 (Week 6). Spirometry was used to measure IC and was performed according to internationally accepted standards. Definitions: Baseline: value of the measurement recorded at 45 mins pre-dose at Visit 2 (Week 0); IC=Inspiratory capacity;

Transition Dyspnea Index (TDI) Response (Focal Score ≥1) at Week 3 and Week 6

Number of subjects achieving TDI focal score ≥1, at treatment visit 3 (Week 3) and at treatment visit 4 (Week 6). TDI is a validated, interviewer-administered questionnaire that measures changes in dyspnea severity from the baseline established by the BDI questionnaire. TDI consists of the same 24 items and 3 domains as the BDI, with the same 2-week recall period. Each category is rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement); total score ranging from -9 to +9, with higher scores indicating better outcomes. The minimal clinically important differences (MCID) is considered a change of ≥1 unit. The same investigator or designee interviewed the subject for the BDI and TDI during the study period. A TDI focal score of ≥1 is considered as clinically important. Definitions: Baseline=The BDI focal score value at Visit 2 (Week 0); BDI=Baseline Dyspnea Index; MCID=Minimal Clinically Important Differences; TDI=Transition Dyspnea Index;

Transition Dyspnea Index (TDI) Focal Score at Week 3 and Week 6

Transitional Dyspnea Index (TDI) focal score at treatment visit 3 (Week 3) and treatment visit 4 (Week 6). TDI is a validated, interviewer-administered questionnaire that measures changes in dyspnea severity from the baseline established by the BDI questionnaire. TDI consists of the same 24 items and 3 domains as the BDI, with the same 2-week recall period. Each category is rated by 7 grades ranging from -3 (major deterioration) to +3 (major improvement), with a total score ranging from -9 to +9, with higher scores indicating better outcomes. The minimal clinically important differences (MCID) is considered a change of ≥1 unit. The same investigator or designee interviewed the subject for the BDI and TDI during the study period. A TDI focal score of ≥1 is considered as clinically important. Definitions: Baseline=The BDI focal score value at Visit 2 (Week 0); BDI=Baseline Dyspnea Index; MCID=Minimal Clinically Important Differences; TDI=Transition Dyspnea Index;

Change From Baseline in Percentage of Rescue Medication-Free Days During Inter-Visit Periods and the Entire Treatment Period

Evaluate the number of rescue medication-free days compared with baseline. Results are shown as percentage (%) of rescue medication-free days; an increased value indicates improvement from baseline. Definitions: Baseline=Data recorded during the run-in period (a 2-week period prior to randomization to study treatment and study drug intake); Inter-visit period 1=Starts at randomization to treatment (Visit 2, Week 0) and runs to the day before the subject returns to the clinic (Visit 3, Week 3); Inter-visit period 2=Starts when the subject returns to the clinic (Visit 3, Week 3) and runs to the end of the randomized treatment period (Visit 4, Week 6); Entire Treatment period=From day of randomization to drug intake to the end of the randomized treatment period (Visit 4, Week 6); Randomization=Randomization to study drug treatment (Visit 2, Week 0).

Change From Baseline in Average Use of Rescue Medication During Inter-Visit Periods and the Entire Treatment Period

Evaluate the change from baseline in average use of rescue medication (number of puffs/day) during the inter-visit periods and the entire treatment period. Results are shown as number of puffs/day; a decrease (implies improvement) from baseline in average use of rescue medication. Definitions: Baseline=Data recorded during the run-in period (a 2-week period prior to randomization to study treatment and study drug intake); Inter-visit period 1=Starts at randomization to treatment (Visit 2, Week 0) and runs to the day before the subject returns to the clinic (Visit 3 (Week 3); Inter-visit period 2=Starts when the subject returns to the clinic (Visit 3, Week 3) and runs to the end of the randomized treatment period (Visit 4, Week 6); Entire Treatment period=From day of randomization to drug intake to the end of the randomized treatment period (Visit 4, Week 6); Randomization=Randomization to study drug treatment (Visit 2, Week 0);

Change From Baseline in Average EXACT-Respiratory Symptom (E-RS) Total Score During Inter-Visit Periods and the Entire Treatment Period

Change from baseline in average EXACT-Respiratory Symptom (E-RS) total score during inter-visit periods and the entire treatment period E-RS in COPD uses 11 respiratory symptom items from the 14-item EXAcerbations of COPD tool (EXACT). E-RS total score quantifies respiratory symptom severity on a scale ranging from 0 to 40. Higher E-RS total scores indicate more severe symptoms and a declining total score indicates health improvement. E-RS questionnaire was completed by the patient each evening (e-diary). Definitions: For details on baseline, inter-visit periods, and the entire treatment period, please refer to outcome measure #15.

Vital Signs -- Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)

Vital signs -- Systolic blood pressure (SBP), Diastolic blood pressure (DBP) were measured at prespecified times, using a 12-Lead single ECGs were recorded at all study visits (pre-dose at V1 (Week -2) and V3 (Week 3), as well as at pre-dose and 1.5 hours post-dose at Visit 2 (Week 0) and Visit 4 (Week 6). Results are shown by treatment group, as change from baseline (in mmHg) for representative timepoints. Definitions: Baseline=Values recorded pre-dose (Visit 2, Week 0); Day 1=Day of the first dose of randomized study drug (Visit 2, Week 0);

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - Heart Rate (HR)

Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - Heart rate (HR) Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5m, +55m, and at +2.5 h.

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - PR Interval

Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - PR Interval Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values were recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - QRS Interval

Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - QRS Interval Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values were recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - Fridericia-corrected QT Interval (QTcF)

Change from baseline in 24-Hour Holter electrocardiogram (ECG) parameters - Fridericia-corrected QT interval (QTcF). Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.

24-hour Holter ECG - Prolonged QTcF - Male Subjects

24-hour Holter ECG - Prolonged QTcF - Male subjects. Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.

24-hour Holter ECG - Prolonged QTcF - Female Subjects

24-hour Holter ECG - Prolonged QTcF - Female subjects. Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h.

24-hour Holter ECG - Prolonged QTcF - Change From Baseline

24-hour Holter ECG - Prolonged QTcF - Change from baseline. Subjects had a 24-h Holter recording before and 24 h after the 1st dose of study drug (Visit 2) and for 24 h before the last dose of study drug (Visit 4). The time-matched values recorded during the 24 h before the 1st dose of study drug on Visit 2 and served as the baseline for the Holter-extracted ECG parameters. The time-averaged baseline score is the average of the Day -1 scores at +5 min, +55 min, and at +2.5 h. Results are presented as the number of subjects who had a change from baseline in QTcF of: > 30 msec, > 60 msec, and no prolongation (by > 30 msec or > 60 msec).

Full Information

NCT ID

NCT03084796

First Posted

March 8, 2017

Last Updated

May 20, 2021

Sponsor

Chiesi Farmaceutici S.p.A.

1. Study Identification

Unique Protocol Identification Number

NCT03084796

Brief Title

A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease

Acronym

GLIMMER

Official Title

A 6-week, Multicenter, Randomized, Double-blind, Placebo and Active-controlled, Parallel Group, Dose-ranging Study to Evaluate the Efficacy and Safety of 4 Doses of CHF 5259 pMDI (HFA Glycopyrronium Bromide Via Pressurized Metered Dose Inhaler) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

July 28, 2017 (Actual)

Primary Completion Date

May 23, 2018 (Actual)

Study Completion Date

June 6, 2018 (Actual)

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

5. Study Description

Brief Summary

The purpose of this study is to evaluate the dose-response of different doses of CHF 5259 pMDI on lung function and other clinical outcomes, to identify the optimal dose(s) in terms of benefit/ risk ratio for further development in the target subject population.

Detailed Description

This is a phase II, multicenter, randomized, double-blind, placebo and active controlled dose-ranging 6-arm parallel group study to identify the optimal dose of CHF 5259 pMDI (pressurized metered dose inhaler) with respect to lung function as well as other clinical efficacy and safety outcomes. After a 2 week run-in period under rescue albuterol and background inhaled corticosteroid (ICS) as needed, patients were randomized to one of the 6 study treatment groups. Following randomization, subjects were assessed after 3 weeks and 6 weeks of study treatment at the study center. A follow-up phone was performed a week after the last visit. During the study, daily symptoms, rescue and background medication use and compliance with the study drug were recorded in a subject diary. Treatment-Emergent Adverse Events (TEAEs) were assessed and recorded throughout the study. At screening and subsequent visits, subjects underwent physical and vital signs examinations, spirometry measurements, and 12-lead electrocardiogram (ECG). Symptoms and chronic obstructive pulmonary disease (COPD) health status were assessed through validated questionnaires. Routine hematology, blood chemistry, and pregnancy testing were performed before enrollment and at end of study. 24-hour (24-H) digital recording of ECGs (Holter) was performed before and after the first dose and just before the last dose of study treatment.

6. Conditions and Keywords

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

COPD, Chronic Obstructive Pulmonary Disease

Keywords

CHF 5259, Chronic Obstructive Pulmonary Disease (COPD), pMDI (pressurized metered dose inhaler), GLIMMER

7. Study Design

Primary Purpose

Other

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

733 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment A

Arm Type

Experimental

Arm Description

CHF 5259 pMDI 6.25 μg, 1 inhalation twice daily (bid); (total daily dose [TDD] of CHF 5259 12.5 μg)

Arm Title

Treatment B

Arm Type

Experimental

Arm Description

CHF 5259 pMDI 12.5 μg, 1 inhalation bid; (TDD of CHF 5259: 25 μg)

Arm Title

Treatment C

Arm Type

Experimental

Arm Description

CHF 5259 pMDI 12.5 μg, 2 inhalations bid; (TDD of CHF 5259: 50 μg)

Arm Title

Treatment D

Arm Type

Experimental

Arm Description

CHF 5259 pMDI 25 μg, 2 inhalations bid; (TDD of CHF 5259: 100 μg)

Arm Title

Treatment E

Arm Type

Placebo Comparator

Arm Description

Placebo, 2 inhalations of CHF 5259 pMDI-matched Placebo bid;

Arm Title

Treatment F

Arm Type

Active Comparator

Arm Description

Tiotropium (TIO) 18 μg, SPIRIVA® HandiHaler®, 2 inhalations once daily (od) of the content of 1 capsule; (TDD of TIO: 18 μg)

Intervention Type

Drug

Intervention Name(s)

CHF 5259

Intervention Description

Dose Response: Test one of four different doses of CHF 5259

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Control

Intervention Type

Drug

Intervention Name(s)

Tiotropium Bromide 18 µg Inhalation Capsule

Other Intervention Name(s)

SPIRIVA® HANDIHALER®

Intervention Description

Active Control

Primary Outcome Measure Information:

Title

Change From Baseline in FEV1 AUC(0-12h) Normalized by Time at Week 6

Description

Time Frame

Baseline, Week 6

Secondary Outcome Measure Information:

Title

Change From Baseline in FEV1 AUC(0-12h) Normalized by Time on Day 1

Description

Time Frame

Baseline, Day 1

Title

Change From Baseline in FEV1 AUC(0-4h) Normalized by Time on Day 1 and at Week 6

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in FEV1 Peak(0-4h) at Day 1 and Week 6

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in FVC AUC(0-12h), Normalized by Time on Day 1 and at Week 6

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in FVC AUC(0-4h) Normalized by Time on Day 1 and at Week 6

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in FVC Peak(0-4h) on Day 1 and at Week 6

Description

Time Frame

Baseline, Day 1, Week 6

Title

Time to Onset of Action (Change From Baseline in Post-dose FEV1 ≥ 100 mL) on Day 1

Description

Time to onset of action is defined as the time (in minutes) from receiving the study drug on Day 1, until the FEV1 change from baseline is ≥100 mL.

Time Frame

Day 1

Title

Number of Patients Achieving Onset of Action - Change From Baseline in Post-dose FEV1 ≥100 mL on Day 1

Description

Time Frame

Day 1

Title

Change From Baseline in Pre-dose Morning FEV1 at Week 3 and Week 6

Description

Time Frame

Baseline, Week 3, Week 6

Title

Change From Baseline in Pre-Dose Morning Inspiratory Capacity (IC) at Week 3 and Week 6

Description

Time Frame

Baseline, Week 3, Week 6

Title

Transition Dyspnea Index (TDI) Response (Focal Score ≥1) at Week 3 and Week 6

Description

Time Frame

Baseline, Week 3, Week 6

Title

Transition Dyspnea Index (TDI) Focal Score at Week 3 and Week 6

Description

Time Frame

Baseline, Week 3, Week 6

Title

Change From Baseline in Percentage of Rescue Medication-Free Days During Inter-Visit Periods and the Entire Treatment Period

Description

Time Frame

Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period

Title

Change From Baseline in Average Use of Rescue Medication During Inter-Visit Periods and the Entire Treatment Period

Description

Time Frame

Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period

Title

Change From Baseline in Average EXACT-Respiratory Symptom (E-RS) Total Score During Inter-Visit Periods and the Entire Treatment Period

Description

Time Frame

Baseline, Inter-visit period 1, Inter-visit period 2, Entire treatment period

Title

Vital Signs -- Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP)

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - Heart Rate (HR)

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - PR Interval

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - QRS Interval

Description

Time Frame

Baseline, Day 1, Week 6

Title

Change From Baseline in 24-Hour Holter Electrocardiogram (ECG) Parameters - Fridericia-corrected QT Interval (QTcF)

Description

Time Frame

Baseline, Day 1, Week 6

Title

24-hour Holter ECG - Prolonged QTcF - Male Subjects

Description

Time Frame

Baseline, Day 1, Week 6

Title

24-hour Holter ECG - Prolonged QTcF - Female Subjects

Description

Time Frame

Baseline, Day 1, Week 6

Title

24-hour Holter ECG - Prolonged QTcF - Change From Baseline

Description

Time Frame

Baseline, Day 1, Week 6

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects aged ≥ 40 who have signed an Informed Consent Form prior to initiation of any study-related procedure. Subjects with a diagnosis of COPD (according to GOLD 2017 Global Strategy for the Diagnosis, Management and Prevention of COPD Report) at least 12 months before the screening visit. Current smokers or ex-smokers who quit smoking at least 6 months prior to screening visit, with a smoking history of at least 10 pack years A post-bronchodilator forced expiratory volume in the 1st second (FEV1) ≥50% and <80% of the predicted normal value and, a post-bronchodilator FEV1/ Forced Vital Capacity (FVC) < 0.7 at screening and a demonstrated reversibility to ipratropium defined as ΔFEV1 ≥ 5% over baseline 30-45 minutes after inhaling 4 puffs of ipratropium Subjects under regular COPD therapy for at least 2 months prior to screening with either inhaled long-acting muscarinic antagonist (LAMA), inhaled ICS/ long-acting β2-agonist (LABA), inhaled ICS + LAMA Symptomatic subjects at screening with a CAT score ≥10. This criterion must be confirmed at randomization Symptomatic subjects with a BDI focal score ≤ 10. This criterion must be confirmed at randomization A cooperative attitude and ability to demonstrate correct use of the inhalers and e-diary. Exclusion Criteria: Pregnant or lactating women and all women physiologically capable of becoming pregnant UNLESS they are willing to use highly effective birth control methods Diagnosis of asthma or Asthma-COPD Overlap Syndrome (ACOS) as described in global initiative for asthma (GINA) Report 2016, history of allergic rhinitis or atopy (atopy which may raise contra-indications or impact the efficacy of the study treatment according to Investigator's judgment) COPD Exacerbations: a moderate or severe COPD exacerbation that has not resolved ≤14 days prior to screening and ≤30 days following the last dose of any oral/systemic corticosteroid or antibiotic (whichever comes last). A Moderate or Severe COPD exacerbation during the run-in period Use of antibiotics for a lower respiratory tract infection in the 4 weeks prior to screening or during run-in Subjects treated with non-cardio-selective β-blockers in the month preceding screening or during the run-in period Subjects treated with long-acting anti-histamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study, or if taken as needed Subjects requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia Known respiratory disorders other than COPD which may impact the efficacy of the study treatment according the Investigator's judgment. Subjects who have clinically significant cardiovascular condition Subjects who have a clinically significant abnormal 12-lead ECG that results in active medical problem which may impact the safety of the subject according to Investigator's judgement Subjects whose 12-lead ECG shows Fridericia corrected QT interval (QTcF) >450 ms for males or QTcF >470 ms for females at screening visit Medical diagnosis of narrow-angle glaucoma, clinically relevant 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-adrenergic receptor agonist, corticosteroids or any of the excipients contained in any of the formulations used in the study which may raise contra-indications or impact the efficacy of the study treatment according to the Investigator's judgement Clinically significant laboratory abnormalities indicating a significant or unstable concomitant disease which may impact the efficacy or the safety of the study treatment according to Investigator's judgement Subjects with serum potassium levels <3.5 mEq/L (or 3.5 mmol/L) at screening Use of potent cytochrome P450 2D6 and 3A4 inhibitors within 4 weeks prior to screening Unstable or uncontrolled concurrent disease; fever, endocrine disease, gastrointestinal disease; neurological disease; hematological disease; autoimmune disorders, or other which may impact the feasibility of the results of the study according to Investigator's judgment History of alcohol abuse and/or substance/drug abuse within 12 months prior to screening 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. Subjects who are mentally or legally incapacitated, or subjects accommodated in an establishment as a result of an official or judicial order. Subjects who have undergone major surgery in the 3 months prior to screening visit or have a planned surgery during the trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Edward Kerwin, MD

Organizational Affiliation

Crisor LLC c/o Clinical Research Institute of Southern Oregon, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Chiesi Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

Chiesi Investigational Site

City

Dothan

State/Province

Alabama

ZIP/Postal Code

36305

Country

United States

Facility Name

Chiesi Investigational Site

City

Montgomery

State/Province

Alabama

ZIP/Postal Code

36106

Country

United States

Facility Name

Chiesi Investigational Site

City

Flagstaff

State/Province

Arizona

ZIP/Postal Code

86001

Country

United States

Facility Name

Chiesi Investigational Site

City

Glendale

State/Province

Arizona

ZIP/Postal Code

85306

Country

United States

Facility Name

Chiesi Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85006

Country

United States

Facility Name

Chiesi Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Chiesi Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

Chiesi Investigational Site

City

Surprise

State/Province

Arizona

ZIP/Postal Code

85374

Country

United States

Facility Name

Chiesi Investigational Site

City

Tempe

State/Province

Arizona

ZIP/Postal Code

85283

Country

United States

Facility Name

Chiesi Investigational Site

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85710

Country

United States

Facility Name

Chiesi Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Chiesi Investigational Site

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Chiesi Investigational Site

City

Fullerton

State/Province

California

ZIP/Postal Code

92835

Country

United States

Facility Name

Clinical Trials Research

City

Lincoln

State/Province

California

ZIP/Postal Code

95648

Country

United States

Facility Name

Chiesi Investigational Site

City

Long Beach

State/Province

California

ZIP/Postal Code

90806

Country

United States

Facility Name

Chiesi Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90017

Country

United States

Facility Name

Chiesi Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90036

Country

United States

Facility Name

Chiesi Investigational Site

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

Chiesi Investigational Site

City

Newport Beach

State/Province

California

ZIP/Postal Code

92663

Country

United States

Facility Name

Chiesi Investigational Site

City

San Diego

State/Province

California

ZIP/Postal Code

92120

Country

United States

Facility Name

Chiesi Investigational Site

City

Tustin

State/Province

California

ZIP/Postal Code

92780

Country

United States

Facility Name

Chiesi Investigational Site

City

Westminster

State/Province

California

ZIP/Postal Code

92683

Country

United States

Facility Name

Chiesi Investigational Site

City

Boulder

State/Province

Colorado

ZIP/Postal Code

80301

Country

United States

Facility Name

Chiesi Investigational Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

Chiesi Investigational Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80230

Country

United States

Facility Name

Chiesi Investigational Site

City

Lafayette

State/Province

Colorado

ZIP/Postal Code

80026

Country

United States

Facility Name

Chiesi Investigational Site

City

Brandon

State/Province

Florida

ZIP/Postal Code

33511

Country

United States

Facility Name

Chiesi Investigational Site

City

Clearwater

State/Province

Florida

ZIP/Postal Code

33765

Country

United States

Facility Name

Chiesi Investigational Site

City

Daytona Beach

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Chiesi Investigational Site

City

Edgewater

State/Province

Florida

ZIP/Postal Code

32132

Country

United States

Facility Name

Chiesi Investigational Site

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Chiesi Investigational Site

City

Kissimmee

State/Province

Florida

ZIP/Postal Code

34741

Country

United States

Facility Name

Chiesi Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33144

Country

United States

Facility Name

Chiesi Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33165

Country

United States

Facility Name

Chiesi Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Chiesi Investigational Site

City

Miami

State/Province

Florida

ZIP/Postal Code

33186

Country

United States

Facility Name

Chiesi Investigational Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32825

Country

United States

Facility Name

Chiesi Investigational Site

City

Panama City

State/Province

Florida

ZIP/Postal Code

32405

Country

United States

Facility Name

Chiesi Investigational Site

City

Blue Ridge

State/Province

Georgia

ZIP/Postal Code

30513

Country

United States

Facility Name

Chiesi Investigational Site

City

Dacula

State/Province

Georgia

ZIP/Postal Code

30019

Country

United States

Facility Name

Chiesi Investigational Site

City

Duluth

State/Province

Georgia

ZIP/Postal Code

30096

Country

United States

Facility Name

Chiesi Investigational Site

City

Lawrenceville

State/Province

Georgia

ZIP/Postal Code

30046

Country

United States

Facility Name

Chiesi Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Chiesi Investigational Site

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31405

Country

United States

Facility Name

Chiesi Investigational Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60607

Country

United States

Facility Name

Chiesi Investigational Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47714

Country

United States

Facility Name

Chiesi Investigational Site

City

Valparaiso

State/Province

Indiana

ZIP/Postal Code

46383

Country

United States

Facility Name

Chiesi Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40215

Country

United States

Facility Name

Chiesi Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40218

Country

United States

Facility Name

Chiesi Investigational Site

City

Crowley

State/Province

Louisiana

ZIP/Postal Code

70526

Country

United States

Facility Name

Chiesi Investigational Site

City

Lake Charles

State/Province

Louisiana

ZIP/Postal Code

70601

Country

United States

Facility Name

Chiesi Investigational Site

City

Lutherville

State/Province

Maryland

ZIP/Postal Code

21093

Country

United States

Facility Name

Chiesi Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02720

Country

United States

Facility Name

Chiesi Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02721

Country

United States

Facility Name

Chiesi Investigational Site

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48106

Country

United States

Facility Name

Chiesi Investigational Site

City

Farmington Hills

State/Province

Michigan

ZIP/Postal Code

48336

Country

United States

Facility Name

Chiesi Investigational Site

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55402

Country

United States

Facility Name

Chiesi Investigational Site

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63301

Country

United States

Facility Name

Chiesi Investigational Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

Chiesi Investigational Site

City

Missoula

State/Province

Montana

ZIP/Postal Code

59808

Country

United States

Facility Name

Chiesi Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68114

Country

United States

Facility Name

Chiesi Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89119

Country

United States

Facility Name

Chiesi Investigational Site

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07901

Country

United States

Facility Name

Chiesi Investigational Site

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87108

Country

United States

Facility Name

Chiesi Investigational Site

City

Bronx

State/Province

New York

ZIP/Postal Code

10455

Country

United States

Facility Name

Chiesi Investigational Site

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

Chiesi Investigational Site

City

Gastonia

State/Province

North Carolina

ZIP/Postal Code

28054

Country

United States

Facility Name

Chiesi Investigational Site

City

Hendersonville

State/Province

North Carolina

ZIP/Postal Code

28739

Country

United States

Facility Name

Chiesi Investigational Site

City

Mooresville

State/Province

North Carolina

ZIP/Postal Code

28117

Country

United States

Facility Name

Chiesi Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27607

Country

United States

Facility Name

Chiesi Investigational Site

City

Shelby

State/Province

North Carolina

ZIP/Postal Code

28150

Country

United States

Facility Name

Chiesi Investigational Site

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Chiesi Investigational Site

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27103

Country

United States

Facility Name

Chiesi Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Chiesi Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43213

Country

United States

Facility Name

Chiesi Investigational Site

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43215

Country

United States

Facility Name

Clinical Research Solutions

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45409

Country

United States

Facility Name

Chiesi Investigational Site

City

Grove City

State/Province

Ohio

ZIP/Postal Code

43123

Country

United States

Facility Name

Chiesi Investigational Site

City

Edmond

State/Province

Oklahoma

ZIP/Postal Code

73034

Country

United States

Facility Name

Chiesi Investigational Site

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73103

Country

United States

Facility Name

Chiesi Investigational Site

City

Medford

State/Province

Oregon

ZIP/Postal Code

97504

Country

United States

Facility Name

Chiesi Investigational Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97202

Country

United States

Facility Name

Chiesi Investigational Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19140

Country

United States

Facility Name

Chiesi Investigational Site

City

East Providence

State/Province

Rhode Island

ZIP/Postal Code

02914

Country

United States

Facility Name

Chiesi Investigational Site

City

Anderson

State/Province

South Carolina

ZIP/Postal Code

29621

Country

United States

Facility Name

Chiesi Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

Chiesi Investigational Site

City

Easley

State/Province

South Carolina

ZIP/Postal Code

29640

Country

United States

Facility Name

Chiesi Investigational Site

City

Fort Mill

State/Province

South Carolina

ZIP/Postal Code

29707

Country

United States

Facility Name

Chiesi Investigational Site

City

Gaffney

State/Province

South Carolina

ZIP/Postal Code

29340

Country

United States

Facility Name

Chiesi Investigational Site

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29615

Country

United States

Facility Name

Chiesi Investigational Site

City

Mount Pleasant

State/Province

South Carolina

ZIP/Postal Code

29464

Country

United States

Facility Name

Chiesi Investigational Site

City

Orangeburg

State/Province

South Carolina

ZIP/Postal Code

29118

Country

United States

Facility Name

Chiesi Investigational Site

City

Rock Hill

State/Province

South Carolina

ZIP/Postal Code

29732

Country

United States

Facility Name

Chiesi Investigational Site

City

Seneca

State/Province

South Carolina

ZIP/Postal Code

29678

Country

United States

Facility Name

Chiesi Investigational Site

City

Spartanburg

State/Province

South Carolina

ZIP/Postal Code

29303

Country

United States

Facility Name

Chiesi Investigational Site

City

Union

State/Province

South Carolina

ZIP/Postal Code

29379

Country

United States

Facility Name

Chiesi Investigational Site

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57702

Country

United States

Facility Name

Chiesi Investigational Site

City

Franklin

State/Province

Tennessee

ZIP/Postal Code

37067

Country

United States

Facility Name

Chiesi Investigational Site

City

Jackson

State/Province

Tennessee

ZIP/Postal Code

38305

Country

United States

Facility Name

Chiesi Investigational Site

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37909

Country

United States

Facility Name

Chiesi Investigational Site

City

Tullahoma

State/Province

Tennessee

ZIP/Postal Code

37388

Country

United States

Facility Name

Chiesi Investigational Site

City

Boerne

State/Province

Texas

ZIP/Postal Code

78006

Country

United States

Facility Name

Chiesi Investigational Site

City

Cypress

State/Province

Texas

ZIP/Postal Code

77429

Country

United States

Facility Name

Chiesi Investigational Site

City

New Braunfels

State/Province

Texas

ZIP/Postal Code

78130

Country

United States

Facility Name

Chiesi Investigational Site

City

Sherman

State/Province

Texas

ZIP/Postal Code

75092

Country

United States

Facility Name

Chiesi Investigational Site

City

Tomball

State/Province

Texas

ZIP/Postal Code

77375

Country

United States

Facility Name

Chiesi Investigational Site

City

South Burlington

State/Province

Vermont

ZIP/Postal Code

05403

Country

United States

Facility Name

Chiesi Investigational Site

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23225

Country

United States

Facility Name

Chiesi Investigational Site

City

Everett

State/Province

Washington

ZIP/Postal Code

98208

Country

United States

Facility Name

Chiesi Investigational Site

City

Richland

State/Province

Washington

ZIP/Postal Code

99352

Country

United States

Facility Name

Chiesi Investigational Site

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

23245604

Citation

Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Barker-Collo S, Bartels DH, Bell ML, Benjamin EJ, Bennett D, Bhalla K, Bikbov B, Bin Abdulhak A, Birbeck G, Blyth F, Bolliger I, Boufous S, Bucello C, Burch M, Burney P, Carapetis J, Chen H, Chou D, Chugh SS, Coffeng LE, Colan SD, Colquhoun S, Colson KE, Condon J, Connor MD, Cooper LT, Corriere M, Cortinovis M, de Vaccaro KC, Couser W, Cowie BC, Criqui MH, Cross M, Dabhadkar KC, Dahodwala N, De Leo D, Degenhardt L, Delossantos A, Denenberg J, Des Jarlais DC, Dharmaratne SD, Dorsey ER, Driscoll T, Duber H, Ebel B, Erwin PJ, Espindola P, Ezzati M, Feigin V, Flaxman AD, Forouzanfar MH, Fowkes FG, Franklin R, Fransen M, Freeman MK, Gabriel SE, Gakidou E, Gaspari F, Gillum RF, Gonzalez-Medina D, Halasa YA, Haring D, Harrison JE, Havmoeller R, Hay RJ, Hoen B, Hotez PJ, Hoy D, Jacobsen KH, James SL, Jasrasaria R, Jayaraman S, Johns N, Karthikeyan G, Kassebaum N, Keren A, Khoo JP, Knowlton LM, Kobusingye O, Koranteng A, Krishnamurthi R, Lipnick M, Lipshultz SE, Ohno SL, Mabweijano J, MacIntyre MF, Mallinger L, March L, Marks GB, Marks R, Matsumori A, Matzopoulos R, Mayosi BM, McAnulty JH, McDermott MM, McGrath J, Mensah GA, Merriman TR, Michaud C, Miller M, Miller TR, Mock C, Mocumbi AO, Mokdad AA, Moran A, Mulholland K, Nair MN, Naldi L, Narayan KM, Nasseri K, Norman P, O'Donnell M, Omer SB, Ortblad K, Osborne R, Ozgediz D, Pahari B, Pandian JD, Rivero AP, Padilla RP, Perez-Ruiz F, Perico N, Phillips D, Pierce K, Pope CA 3rd, Porrini E, Pourmalek F, Raju M, Ranganathan D, Rehm JT, Rein DB, Remuzzi G, Rivara FP, Roberts T, De Leon FR, Rosenfeld LC, Rushton L, Sacco RL, Salomon JA, Sampson U, Sanman E, Schwebel DC, Segui-Gomez M, Shepard DS, Singh D, Singleton J, Sliwa K, Smith E, Steer A, Taylor JA, Thomas B, Tleyjeh IM, Towbin JA, Truelsen T, Undurraga EA, Venketasubramanian N, Vijayakumar L, Vos T, Wagner GR, Wang M, Wang W, Watt K, Weinstock MA, Weintraub R, Wilkinson JD, Woolf AD, Wulf S, Yeh PH, Yip P, Zabetian A, Zheng ZJ, Lopez AD, Murray CJ, AlMazroa MA, Memish ZA. Global and regional mortality from 235 causes of death for 20 age groups in 1990 and 2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012 Dec 15;380(9859):2095-128. doi: 10.1016/S0140-6736(12)61728-0. Erratum In: Lancet. 2013 Feb 23;381(9867):628. AlMazroa, Mohammad A [added]; Memish, Ziad A [added].

Results Reference

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24107140

Citation

Tilert T, Dillon C, Paulose-Ram R, Hnizdo E, Doney B. Estimating the U.S. prevalence of chronic obstructive pulmonary disease using pre- and post-bronchodilator spirometry: the National Health and Nutrition Examination Survey (NHANES) 2007-2010. Respir Res. 2013 Oct 9;14(1):103. doi: 10.1186/1465-9921-14-103.

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Citation

Mannino DM. COPD: epidemiology, prevalence, morbidity and mortality, and disease heterogeneity. Chest. 2002 May;121(5 Suppl):121S-126S. doi: 10.1378/chest.121.5_suppl.121s.

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Citation

Tonnesen P. Smoking cessation and COPD. Eur Respir Rev. 2013 Mar 1;22(127):37-43. doi: 10.1183/09059180.00007212.

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PubMed Identifier

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Citation

van Eerd EA, van der Meer RM, van Schayck OC, Kotz D. Smoking cessation for people with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2016 Aug 20;2016(8):CD010744. doi: 10.1002/14651858.CD010744.pub2.

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PubMed Identifier

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Citation

Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;(10):CD010177. doi: 10.1002/14651858.CD010177.pub2.

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result

Links:

URL

https://goldcopd.org/wp-content/uploads/2017/02/wms-GOLD-2017-FINAL.pdf

Description

From the Global Strategy for the Diagnosis, Management and Prevention of COPD, Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2017.

URL

https://www.chiesi.com/en/air/

Description

Chiesi Respiratory

URL

https://www.chiesi.com/en/chiesi-farmaceutici-is-the-first-company-to-submit-a-marketing-authorisation-application-to-the-european-medicine-agency-for-a-triple-combination-for-the-treatment-of-copd-

Description

Chiesi Farmaceutici is the first company to submit a marketing authorisation application to the European Medicine Agency for a Triple Combination for the treatment of COPD

URL

https://en.wikipedia.org/wiki/Glycopyrronium_bromide

Description

Glycopyrronium bromide

URL

http://www.thoracic.org/members/assemblies/assemblies/srn/questionaires/bdi-tdi.php

Description

American Thoracic Society: Baseline Dyspnea Index (BDI) & Transition Dyspnea Index (TDI).

URL

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

Description

American Thoracic Society: COPD Assessment Test (CAT).

Learn more about this trial

A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease

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A 6-week Dose Ranging Study of CHF 5259 pMDI in Subjects With Chronic Obstructive Pulmonary Disease (GLIMMER)

COPD, Chronic Obstructive Pulmonary Disease

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

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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