Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Official Title
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A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Drug: PT003
* Drug: PT001
* Drug: PT005
* Drug: Tiotropium inhalation powder


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Signed written informed consent 40 - 80 years of age Clinical history of COPD with airflow limitation that is not fully reversible Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods Current/former smokers with at least a 10 pack-year history of cigarette smoking A measured post-bronchodilator FEV1/FVC ratio of < or = 0.70 A measured post-bronchodilator FEV1 > or = 750ml or 30% predicted and < or = 80% of predicted normal values Able to change COPD treatment as required by protocol Key Exclusion Criteria: Women who are pregnant or lactating Primary diagnosis of asthma Alpha-1 antitrypsin deficiency as the cause of COPD Active pulmonary diseases Prior lung volume reduction surgery Abnormal chest X-ray not due to the presence of COPD Hospitalized due to poorly controlled COPD within 3 months of Screening Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) Cancer that has not been in complete remission for at least 5 years Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives Other inclusion/exclusion criteria as defined in the protocol

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PT003 (Dose 1)<br>PT003 MDI Dose 1 | Drug: PT003<br>* PT003 MDI administered as two puffs BID for 7 days<br>|
| Experimental: PT003 (Dose 2)<br>PT003 MDI Dose 2 | Drug: PT003<br>* PT003 MDI administered as two puffs BID for 7 days<br>|
| Experimental: PT003 (Dose 3)<br>PT003 MDI Dose 3 | Drug: PT003<br>* PT003 MDI administered as two puffs BID for 7 days<br>|
| Experimental: PT003 (Dose 4)<br>PT003 MDI Dose 4 | Drug: PT003<br>* PT003 MDI administered as two puffs BID for 7 days<br>|
| Experimental: PT003 (Dose 5)<br>PT003 MDI Dose 5 | Drug: PT003<br>* PT003 MDI administered as two puffs BID for 7 days<br>|
| Experimental: PT001<br>PT001 MDI | Drug: PT001<br>* PT001 MDI administered as two puffs BID for 7 days<br>|
| Experimental: PT005<br>PT005 MDI | Drug: PT005<br>* PT005 MDI administered as two puffs BID for 7 days<br>|
| Active Comparator: Spiriva® Handihaler®<br>Tiotropium Bromide | Drug: Tiotropium inhalation powder<br>* Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 AUC 0-12 on Day 7 | FEV1 AUC 0-12 | Day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Change From Baseline in FEV1 on Treatment Day 1 | Peak change from Baseline in FEV1 on Treatment | Day 1 | 
| Time to Onset of Action (>10% Improvement in FEV1) on Day 1 | Time to onset of action (>10% improvement in FEV1) | Day 1 | 
| Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1 | Proportion of subjects achieving >=12% improvement in FEV1 | Day 1 | 
| Peak Change From Baseline in Inspiratory Capacity on Day 1 | Peak change from baseline in Inspiratory Capacity | Day 1 | 
| Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7 | Change from baseline in morning pre-dose trough FEV1 | Day 7 | 
| Peak Change From Baseline in FEV1 on Day 7 | Peak change from baseline in FEV1 Day 7 | Day 7 | 
| Change From Baseline in Morning Pre-dose Trough IC on Day 7 | Change from baseline in morning pre-dose trough IC | Day 7 | 
| Peak Change From Baseline IC on Day 7 | Peak change from baseline IC | Day 7 | 
| Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7 | Change from baseline at evening 12-hour post-dose trough FEV1 | Day 7 | 
| Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean morning pre-dose daily peak flow readings | Day 7 | 
| Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean morning post-dose daily peak flow readings on | Day 7 | 
| Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only) | Day 7 | 
| Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7 | Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva) | Day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD