Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: PH-797804; Drug: Placebo

• Registration Number: NCT01321463
• Lead Sponsor: Pfizer

Brief Summary

PH-797804 is an oral ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-03-21
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-07
• Disposition First Submitted: 2013-07-08
• Disposition First Submitted QC: 2013-07-08
• Last Update Submitted: 2013-07-08
• Disposition First Posted: 2013-07-11
• Last Update Posted: 2013-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 377

Inclusion Criteria

• Male or female subjects between, and including, the ages of 40 and 80 years.
• Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease.
• Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago.
• Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.

Exclusion Criteria

• A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
• History or presence of significant cardiovascular disease.
• ECG abnormalities.
• Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
• Evidence of organ or blood disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PH-797804	PH-797804	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.	12 Weeks
Dyspnea index scores.	12 Weeks
Rescue bronchodilator usage.	12 Weeks
Symptom scores.	12 Weeks
Global impression of change (patient and clinician).	12 Weeks
Blood sample for pharmacokinetics.	12 Weeks
Blood and urine sample for biomarkers and molecular profiling.	12 Weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Glasgow, United Kingdom