Phase 2
N=22
A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease
Pulmonary Disease, Chronic Obstructive · Lung Diseases · Respiratory Tract Diseases · Chronic Obstructive Airway Disease · COPD
Bottom Line
View on ClinicalTrials.gov: NCT01033487 ↗Enrolled (actual)
22
Serious AEs
0.9%
Results posted
Feb 2016
Primary outcome: Primary: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) — 1.61; 1.58; 1.62; 1.62 Liter
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- placebo (Drug); active comparator (Drug); Low Dose PF-03635659 (Drug); Mid Dose PF-03635659 (Drug); High Dose PF-03635659 (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) |
1.61; 1.58; 1.62; 1.62; 1.67; 0.147 | — |
| PRIMARY Maximum Observed Plasma Concentration (Cmax) |
53.21; 169.4; 471.2 | — |
| PRIMARY Dose Normalized Maximum Observed Plasma Concentration |
1.331; 1.323; 1.474 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) |
0.533; 0.950; 0.467 | — |
| PRIMARY Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) |
598.40; 2513.00 | — |
| PRIMARY Dose Normalized Area Under the Curve From Time Zero to Last Quantifiable Concentration |
4.676; 7.856 | — |
| PRIMARY Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC(0-∞)] |
— | — |
| PRIMARY Dose Normalized Area Under the Curve From Time Zero Extrapolated to Infinite Time |
— | — |
| PRIMARY Plasma Decay Half-Life (t1/2) |
— | — |
| SECONDARY Peak Forced Expiratory Volume in 1 Second (FEV1) |
0.270; 0.380; 0.383; 0.325; 0.139 | — |
| SECONDARY Weighted Average Forced Expiratory Volume in 1 Second (FEV1) Response |
0.091; 0.167; 0.172; 0.149; -0.033 | — |
| SECONDARY Change From Baseline in Force Vital Capacity (FVC) |
3.461; 3.421; 3.474; 3.457; 3.522; 0.212 | — |
| SECONDARY Change From Baseline in Inspiratory Capacity (IC) |
2.517; 2.559; 2.488; 2.473; 2.543; 0.090 | — |
Summary
PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).
Eligibility Criteria
Inclusion Criteria
- Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
- Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
- Current smokers, or ex-smokers who have abstained from smoking for at least 6 months
Exclusion Criteria
- Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
- History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.
Data sourced from ClinicalTrials.gov (NCT01033487). 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.