Phase 3
Completed N=2,361
Study to Assess Efficacy and Safety of PT009 Compared to PT005, PT008, and Symbicort® Turbuhaler® on Lung Function Over 24-Weeks in Subjects With Moderate to Very Severe COPD
Chronic Obstructive Pulmonary Disorder
Source: ClinicalTrials.gov NCT02766608 ↗
Enrolled (actual)
2,361
Serious AEs
8.2%
Results posted
Sep 2019
Primary outcomePrimary: Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI) — 0.036; 0.017; -0.003 Liter
◆ Published Evidence
Established
27citations · ~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, 24-week lung function study with BFF MDI (320/9.6 μg and 160/9.6 μg) compared to FF MDI 9.6 μg, BD MDI 320 μg, and open-label Symbicort® TBH (200/6 μg) administered BID.
Linked Publications (2)
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Predictive modeling of COPD exacerbation rates using baseline risk factors.
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Budesonide/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI Versus FF MDI) |
0.036; 0.017; -0.003 | — |
| PRIMARY Change From Baseline in FEV1 AUC0-4 (BFF MDI vs BD MDI) |
0.194; 0.179; 0.161; 0.022; 0.187 | — |
| SECONDARY Time to First Moderate or Severe COPD Exacerbation (BFF MDI vs FF MDI). |
3.2; 3.3; 5.5; 7.0; 1.8; 9.8 | — |
| SECONDARY Percentage of Subjects Achieving an MCID (Minimal Clinically Important Difference) of 4 Units or More in SGRQ at Week 24 |
48.12; 47.22; 41.59; 43.62; 53.78 | — |
| SECONDARY Change From Baseline in Morning Pre-dose Trough FEV1 at Week 24 (BFF MDI vs BD MDI) |
0.036; 0.017; -0.003; -0.028; 0.039 | — |
| SECONDARY Peak Change From Baseline in FEV1 at Week 24 (BFF MDI vs BD MDI) |
0.272; 0.258; 0.243; 0.116; 0.267 | — |
| SECONDARY Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks (BFF MDI vs BD MDI) |
-1.3; -1.3; -1.1; -0.6; -1.2 | — |
| SECONDARY FEV1 on Day 1, 5 Minutes, Time to Onset of Action Determination |
0.157; 0.151; 0.160; 0.025; 0.131 | — |
| SECONDARY FEV1 on Day 1, 15 Minutes, Time to Onset of Action Determination |
0.190; 0.186; 0.201; 0.040; 0.167 | — |
| SECONDARY FEV1 on Day 1, 30 Minutes, Time to Onset of Action Determination |
0.207; 0.207; 0.215; 0.047; 0.190 | — |
| SECONDARY FEV1 on Day 1, 1 Hour, Time to Onset of Action Determination |
0.225; 0.221; 0.236; 0.053; 0.211 | — |
| SECONDARY FEV1 on Day 1, 2 Hours, Time to Onset of Action Determination |
0.253; 0.234; 0.244; 0.063; 0.221 | — |
| SECONDARY FEV1 on Day 1, 4 Hours, Time to Onset of Action Determination |
0.230; 0.215; 0.212; 0.073; 0.209 | — |
Eligibility Criteria
Inclusion Criteria
- Give their signed written informed consent to participate
- Are at least 40 years of age and no older than 80 years
- COPD patients who are symptomatic
- Must be receiving one or more inhaled bronchodilators as maintenance therapy
Exclusion Criteria
- Current diagnosis of asthma,
- COPD due to α1-Antitrypsin Deficiency
- Known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months
- Long-term-oxygen therapy (≥ 12 hours a day).
Data sourced from ClinicalTrials.gov (NCT02766608) 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.