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PF-04191834 Single Dose Bronchodilatory Study In Asthma.

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Asthma

Intervention: PF-04191834 (Drug); PF-04191834 (Drug); PF-04191834 (Drug); zileuton (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

Official title: A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.

Study design: Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Secondary outcome:

Change From Baseline in Forced Vital Capacity (FVC)

Change From Baseline in Forced Vital Capacity (FVC)

Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)

Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Pfizer Investigational Site, Baltimore, Maryland 21225, United States

Pfizer Investigational Site, North Dartmouth, Massachusetts 02747, United States

Pfizer Investigational Site, Kalamazoo, Michigan 49007, United States

Pfizer Investigational Site, Omaha, Nebraska 68131, United States

Additional Information

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

Starting date: July 2008
Last updated: December 27, 2012

Page last updated: August 23, 2015

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