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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer

Criteria

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.