Phase 2
Completed N=122
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
Source: ClinicalTrials.gov NCT01085045 ↗Enrolled (actual)
122
Serious AEs
1.4%
Results posted
Apr 2017
Primary outcomePrimary: FEV1 AUC 0-12 on Day 7 — 1.537; 1.529; 1.429; 1.434 Liters
Summary
The purpose of this study is to evaluate, after 1 week of dosing, the efficacy and safety of PT003 compared with its individual components (PT001 and PT005), placebo and two active comparators to demonstrate superiority of the combination to its components, and to assess the relative contribution of the components compared with placebo, in patients with moderate to very severe COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1 AUC 0-12 on Day 7 |
1.537; 1.529; 1.429; 1.434; 1.421; 1.413 | — |
| SECONDARY Peak Change From BL in FEV1 on Day 1 |
0.370; 0.357; 0.289; 0.266; 0.308; 0.310 | — |
| SECONDARY Peak Change From BL in FEV1 on Day 7 |
0.438; 0.440; 0.313; 0.298; 0.337; 0.330 | — |
| SECONDARY Peak Change From BL in Inspiratory Capacity on Day 1 |
0.495; 0.411; 0.430; 0.347; 0.362; 0.352 | — |
| SECONDARY Peak Change From BL IC on Day 7 |
0.409; 0.438; 0.331; 0.314; 0.359; 0.376 | — |
| SECONDARY Time to Onset of Action >=10% Improvement in FEV1 on Day 1 |
22; 20; 14; 22; 37; 34 | — |
| SECONDARY Percentage of Patients Achieving >=12% Improvement in FEV1 on Day 1 |
86.84; 87.18; 73.68; 66.07; 84.48; 82.54 | — |
| SECONDARY Change in Morning Pre-dose FEV1 on Day 7 |
0.193; 0.170; 0.097; 0.097; 0.064; 0.073 | — |
| SECONDARY 12 hr Post-dose Trough FEV1 on Day 7 |
1.405; 1.441; 1.383; 1.398; 1.349; 1.378 | — |
| SECONDARY Change From BL in Mean Morning Pre-dose Daily Peak Flow Rate on Day 7 |
30.263; 28.152; 16.439; 11.817; 12.424; 10.211 | — |
| SECONDARY Change From BL in Mean Morning Post-dose Daily Peak Flow Rate on Day 7 |
56.666; 53.411; 33.652; 27.668; 41.287; 38.712 | — |
| SECONDARY Change From BL in Mean Evening Pre-dose Daily Peak Flow Rate on Day 7 |
35.0945; 30.817; 18.487; 17.190; 14.805; 17.789 | — |
| SECONDARY Change From BL in Mean Evening Post-dose Daily Peak Flow Rate on Day 7 |
53.863; 58.326; 36.637; 24.253; 41.395; 37.192 | — |
Eligibility Criteria
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 = 750ml or 30% predicted and < or = 80% of predicted normal values
- Able to change COPD treatment as required by protocol
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 (or CT scan) 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 protocol defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01085045). 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.