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

NCT ID: NCT00783406

Last Updated: 2010-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-03-31

Brief Summary

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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

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Conditions

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Pulmonary Disease, Chronic Obstructive

Keywords

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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PF- 00610355

Group Type EXPERIMENTAL

PF-00610355

Intervention Type DRUG

dry powder inhaler, 1472 mcg, single dose

PF-00610355

Group Type EXPERIMENTAL

PF-00610355

Intervention Type DRUG

dry powder inhaler, 736 mcg, single dose

PF -00610355

Group Type EXPERIMENTAL

PF-00610355

Intervention Type DRUG

dry powder inhaler, 368 mcg, single dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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PF-00610355

dry powder inhaler, 1472 mcg, single dose

Intervention Type DRUG

PF-00610355

dry powder inhaler, 736 mcg, single dose

Intervention Type DRUG

PF-00610355

dry powder inhaler, 368 mcg, single dose

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer, Inc.

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Berlin, , Germany

Site Status

Pfizer Investigational Site

Wiesbaden, , Germany

Site Status

Countries

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Germany

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7881010&StudyName=Safety%2C%20Toleration%20and%20Efficacy%20of%20Single%20Inhaled%20Doses%20of%20PF-00610355%20in%20Chronic%20Obstructive%20Pulmonary%20%28COPD%29%20Patients.

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Other Identifiers

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A7881010

Identifier Type: -

Identifier Source: org_study_id