A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

Study Overview
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Brief Summary
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This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

Detailed Description
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This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Official Title
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A Randomized, Double-Blind, Parallel Group, Multi-Center Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD

Conditions
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Chronic Obstructive Pulmonary Disorder

Intervention / Treatment
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* Drug: BFF MDI (PT009) 320/9.6 μg
* Drug: BFF MDI (PT009) 160/9.6 μg
* Drug: FF MDI (PT005) 9.6 μg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Give their signed written informed consent to participate At least 40 years of age and no older than 80 years of age COPD patients who are symptomatic Must be receiving one or more inhaled bronchodilators as maintenance therapy Must have a documented history of COPD exacerbations Exclusion Criteria: Current diagnosis of asthma COPD due to α1-Antitrypsin Deficiency Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months. Long-term-oxygen therapy (≥ 15 hours a day).

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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BFF MDI (PT009) 320/9.6 μg<br>Budesonide and Formoterol Fumarate Inhalation Aerosol - 160/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: BFF MDI (PT009) 320/9.6 μg<br>* Blinded Treatment<br>* Other names: Budesonide and Formoterol Fumarate Inhalation Aerosol;|
| Experimental: BFF MDI (PT009) 160/9.6 μg<br>Budesonide and Formoterol Fumarate Inhalation Aerosol - 80/4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: BFF MDI (PT009) 160/9.6 μg<br>* Blinded Treatment<br>* Other names: Budesonide and Formoterol Fumarate Inhalation Aerosol;|
| Experimental: FF MDI (PT005) 9.6 μg<br>Formoterol Fumarate Inhalation Aerosol - 4.8 μg per actuation MDI/120 inhalations Taken as 2 inhalations BID | Drug: FF MDI (PT005) 9.6 μg<br>* Blinded Treatment<br>* Other names: Formoterol Fumarate Inhalation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morning Pre-dose Trough FEV1 | Morning pre-dose trough FEV1 (Forced Expiratory Volume in one second) at week 12 | at Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Moderate or Severe COPD Exacerbation | Time to first moderate or severe COPD (Chronic Obstructive Pulmonary Disease) exacerbation over 52 weeks | over 52 weeks | 
| Change From Baseline in Average Daily Rescue Ventolin HFA Use | Change from baseline in average daily rescue Ventolin HFA use over 12 weeks | over 12 weeks | 
| Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score | The SGRQ (St. George's Respiratory Questionnaire) is a disease-specific questionnaire, self-completed by participants, used to evaluate the effect of BFF MDI on health-related quality of life as compared to FF MDI in subjects with COPD. The scores range from 0 (minimum, best possible health status) to 100 (maximum, worst possible health status). The SGRQ contains 76 items grouped into three domains (symptoms, activity and impacts). Change from Baseline at a particular visit was calculated as the SGRQ total score at that visit minus Baseline. A decrease from baseline in SGRQ total score of 4 units or more is considered a clinically meaningful improvement in quality of life. | at Week 12 | 

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