Phase 3
Completed N=1,843
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)
Chronic Obstructive Pulmonary Disorder
Source: ClinicalTrials.gov NCT02727660 ↗
Enrolled (actual)
1,843
Serious AEs
12.0%
Results posted
Sep 2019
Primary outcomePrimary: Morning Pre-dose Trough FEV1 — 0.072; 0.069; 0.037 Liter
◆ Published Evidence
Established
26citations · ~7 / year
Predictive modeling of COPD exacerbation rates using baseline risk factors.
Summary
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.
Linked Publications
-
Predictive modeling of COPD exacerbation rates using baseline risk factors.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morning Pre-dose Trough FEV1 |
0.072; 0.069; 0.037 | — |
| SECONDARY Time to First Moderate or Severe COPD Exacerbation |
19.2; 19.3; 24.8; 31.2; 32.9; 35.1 | — |
| SECONDARY Change From Baseline in Average Daily Rescue Ventolin HFA Use |
-0.9; -0.9; -0.6 | — |
| SECONDARY Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in Saint George's Respiratory Questionnaire (SGRQ) Total Score |
52; 54; 44 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT02727660) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.