Clinical trial NCT02366637: An Evaluation Of PF-03715455 In Moderate To Severe Chronic Obstructive Pulmonary Disease
Official title: A Randomized, Double-blind, Placebo-controlled 2-way Crossover Study To Evaluate The Efficacy, Safety And Tolerability Of Pf-03715455 Administered Twice Daily By Inhalation For 4 Weeks In Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease (Copd)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: COPD
Sputum
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2015-02-19
Enrollment: 13
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study proposes to evaluate the safety and efficacy of PF-03715455 in subjects with moderate to severe Chronic Obstructive Pulmonary Disorder.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 4
timeFrame: Baseline (Day 1), Day 29 (Week 4)
Secondary outcomes:
measure: Change From Baseline in Sputum Cell Counts Over 4 Weeks
timeFrame: Baseline, Week 1 to Week 4
measure: Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) at Weeks 1, 3, and 4
timeFrame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4)
measure: Change From Baseline in Trough FEV1 and Forced Vital Capacity (FVC) Over 4 Weeks
timeFrame: Baseline, Week 1 to Week 4
measure: Maximum Observed Plasma Concentrations (Cmax) of PF-03715455
timeFrame: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
measure: Trough Plasma Concentration (Ctrough) of PF-03715455
timeFrame: Pre-dose on Day 7 and Day 21; post-dose on Day 7 (10 minutes and 1 hour post-dose) and Day 29
Other outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 29 (Week 4)
measure: Number of Participants With Clinically Significant Treatment Emergent Electrocardiogram (ECG) Findings
timeFrame: Baseline up to Day 29 (Week 4)
measure: Change From Baseline in Systolic and Diastolic Blood Pressure
timeFrame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
measure: Change From Baseline in Pulse Rate
timeFrame: Baseline, Day 7 (Week 1), Day 21 (Week 3), Day 29 (Week 4), Day 49 (follow-up)
measure: Number of Participants With Laboratory Abnormalities
timeFrame: Baseline up to Week 4
Locations:
city: Wythenshawe
country: United Kingdom
facility: Medicines Evaluation Unit Ltd
state: Manchester
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust
state: Nottinghamshire
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Foundation Trust
city: Bradford
country: United Kingdom
facility: Respiratory Medicine, Bradford Institute of Health Research
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: