PF-04191834 Single Dose Bronchodilatory Study In Asthma.

NCT ID: NCT00723021

Last Updated: 2013-02-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2009-07-31

Brief Summary

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Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PF-04191834 30mg

Group Type EXPERIMENTAL

PF-04191834

Intervention Type DRUG

30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.

PF-04191834 100mg

Group Type EXPERIMENTAL

PF-04191834

Intervention Type DRUG

100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.

PF-04191834 2000mg

Group Type EXPERIMENTAL

PF-04191834

Intervention Type DRUG

2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose

zileuton

Group Type ACTIVE_COMPARATOR

zileuton

Intervention Type DRUG

1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.

placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

2 x placebo tablets + placebo oral dispersion, single dose.

Interventions

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PF-04191834

30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.

Intervention Type DRUG

PF-04191834

100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.

Intervention Type DRUG

PF-04191834

2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose

Intervention Type DRUG

zileuton

1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.

Intervention Type DRUG

Placebo

2 x placebo tablets + placebo oral dispersion, single dose.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Persistent mild/moderate asthma for at least 6 months.
* Reduced lung function
* Reversible airway obstruction

Exclusion Criteria

* Pregnant/nursing females.
* Liver function tests greater than upper limit of normal (ULN)
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

North Dartmouth, Massachusetts, United States

Site Status

Pfizer Investigational Site

Kalamazoo, Michigan, United States

Site Status

Pfizer Investigational Site

Omaha, Nebraska, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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B0041002

Identifier Type: -

Identifier Source: org_study_id

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