An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Placebo
- Registration Number
- NCT02366637
- Lead Sponsor
- Pfizer
- Brief Summary
This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 13
- Female subjects of non-childbearing potential and male subjects between the ages of 40 and 80 years, inclusive
- Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD and who meet the criteria for Stage II-III disease
- Subjects must have a smoking history of at least 10 pack-years
- Current evidence or history within the previous 6 months of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data
- A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of Screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description PF-03715455 PF-03715455 - Placebo Placebo Double blind placebo for PF-03715455
- Primary Outcome Measures
Name Time Method Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4 Baseline (Day 1), Day 29 (Week 4) FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. Trough FEV1 was obtained from spirometry, performed before study treatment administration.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Sputum Cell Counts Over 4 Weeks Baseline, Week 1 to Week 4 Sputum cell counts included total neutrophils counts and differential (percent \[%\]), total cell count, total macrophage count and differential (%). Change over 4 weeks was to be presented.
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4 Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4) FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 Baseline and Change at Week 4 are already reported under Primary Outcome Measure 1.
Trough Plasma Concentration (Ctrough) of PF-03715455 Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29 Ctrough is the concentration prior to study drug administration.
Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks Baseline, Week 1 to Week 4 FEV1 is the maximal volume of air exhaled in the first second of a forced expiration from a position of full inspiration. FVC is the volume of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Change over 4 weeks is presented.
Maximum Observed Plasma Concentrations (Cmax) of PF-03715455 Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Trial Locations
- Locations (5)
Nottingham University Hospital NHS Trust
🇬🇧Nottingham, Nottinghamshire, United Kingdom
University Hospitals Birmingham NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Heart of England NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
Respiratory Medicine, Bradford Institute of Health Research
🇬🇧Bradford, United Kingdom
Medicines Evaluation Unit Ltd
🇬🇧Wythenshawe, Manchester, United Kingdom