Status:
COMPLETED
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
Lead Sponsor:
Pfizer
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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 exp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00783406
Start Date
October 1 2008
End Date
March 1 2009
Last Update
November 1 2010
Active Locations (2)
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1
Pfizer Investigational Site
Berlin, Germany, 10117
2
Pfizer Investigational Site
Wiesbaden, Germany, 65187