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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— A7881010  

Official title:

A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783406
• Other study ID #: A7881010
• Status: Completed
• Phase: Phase 2
• First received: October 30, 2008
• Last updated: October 27, 2010
• Start date: October 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: BfArM
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PF-00610355
dry powder inhaler, 1472 mcg, single dose
• PF-00610355
dry powder inhaler, 736 mcg, single dose
• PF-00610355
dry powder inhaler, 368 mcg, single dose
• Placebo
Placebo

Locations

Country	Name	City	State
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Wiesbaden

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.		up to 8 days post dose	Yes
Primary	To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients		up to 24 hours post dose	Yes
Secondary	To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.		up to 24 hours post dose	Yes
Secondary	To investigate the exposure/response relationship of PF-00610355.		up to 8 days post dose	Yes

External Links

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