A7881010: Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00783406

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: PF-00610355 Drug: PF-00610355 Drug: PF-00610355 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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.

Study Start Date :

Oct 1, 2008

Actual Primary Completion Date :

Mar 1, 2009

Actual Study Completion Date :

Mar 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF- 00610355	Drug: PF-00610355 dry powder inhaler, 1472 mcg, single dose
Experimental: PF-00610355	Drug: PF-00610355 dry powder inhaler, 736 mcg, single dose
Experimental: PF -00610355	Drug: PF-00610355 dry powder inhaler, 368 mcg, single dose
Placebo Comparator: Placebo	Drug: Placebo Placebo

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Berlin		Germany	10117
2	Pfizer Investigational Site	Wiesbaden		Germany	65187

Sponsors and Collaborators

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

To obtain contact information for a study center near you, click here.

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00783406

Other Study ID Numbers:

A7881010

First Posted:

Oct 31, 2008

Last Update Posted:

Nov 1, 2010

Last Verified:

Oct 1, 2010

Keywords provided by , ,

COPD

Additional relevant MeSH terms:

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Nov 1, 2010