Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

Phase 2

Completed

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Placebo; Drug: PF-00610355

• Registration Number: NCT00783406
• Lead Sponsor: Pfizer

Brief Summary

This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Study First Submitted: 2008-10-30
• Study First Submitted QC: 2008-10-30
• Study First Posted: 2008-10-31
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Disposition First Submitted: 2009-03-24
• Status Verified: 2010-10
• Disposition First Submitted QC: 2010-10-27
• Last Update Submitted: 2010-10-27
• Disposition First Posted: 2010-11-01
• Last Update Posted: 2010-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Post-bronchodilator FEV1/ FVC ratio of <0.7.
• Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
• Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
PF -00610355	PF-00610355	-
PF- 00610355	PF-00610355	-
PF-00610355	PF-00610355	-

Primary Outcome Measures

Name	Time	Method
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.	up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients	up to 24 hours post dose

Secondary Outcome Measures

Name	Time	Method
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.	up to 24 hours post dose
To investigate the exposure/response relationship of PF-00610355.	up to 8 days post dose

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇩🇪 Wiesbaden, Germany