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)
| Status: | Completed |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 40 - 80 |
| Updated: | 5/2/2018 |
| Start Date: | April 29, 2016 |
| End Date: | March 30, 2018 |
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
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.
exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6
μg, all administered BID.
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.
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.
Inclusion Criteria:
1. Give their signed written informed consent to participate
2. At least 40 years of age and no older than 80 years of age
3. COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
5. Must have a documented history of COPD exacerbations
Exclusion Criteria:
1. Current diagnosis of asthma
2. COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant
bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6
months.
4. Long-term-oxygen therapy (≥ 15 hours a day).
We found this trial at
111
sites
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