A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Phase 2

Completed

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

• Registration Number: NCT00559910
• Lead Sponsor: Pfizer

Brief Summary

PH-797804 is a potent 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: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Study Start: 2008-02
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

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 had stable disease for at least 1 month prior to screening.
• 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.

Exclusion Criteria

• More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
• 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
Placebo	Placebo	Placebo
PH-797804	PH-797804	PH-797804 at four dose levels

Primary Outcome Measures

Name	Time	Method
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.	6 weeks
Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Dyspnea index scores.	6 weeks
Blood sample for biomarkers	6 weeks
Peak expiratory flow rate.	6 weeks
Blood sample for pharmacogenomics	6 weeks
Blood sample for pharmacokinetics	6 weeks
Rescue bronchodilator usage.	6 weeks
Global impression of change (patient and clinician).	6 weeks
Symptom scores.	6 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇬🇧 Edinburgh, United Kingdom