PF-04191834 Single Dose Bronchodilatory Study In Asthma. - Full Text View

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00723021

Purpose

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

Condition	Intervention	Phase
Asthma	Drug: PF-04191834 Drug: zileuton Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Pharmacodynamics Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Zileuton

Further study details as provided by Pfizer:

Primary Outcome Measures:

Pulmonary function test [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Safety and toleration [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	15
Study Start Date:	July 2008
Study Completion Date:	July 2009
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PF-04191834 30mg: Experimental	Drug: PF-04191834 30mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets.
PF-04191834 100mg: Experimental	Drug: PF-04191834 100mg PF-04191834, single dose, oral dispersion + 2 x placebo tablets, single dose.
PF-04191834 2000mg: Experimental	Drug: PF-04191834 2000mg PF-04191834, single dose, oral dispersion + 2 x placebo tables, single dose
zileuton: Active Comparator	Drug: zileuton 1200mg, 2 x 600mg tablets, single dose + placebo oral dispersion, single dose.
placebo: Placebo Comparator	Drug: Placebo 2 x placebo tablets + placebo oral dispersion, single dose.

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723021

Locations

United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21225
United States, Massachusetts
Pfizer Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Nebraska
Pfizer Investigational Site
Omaha, Nebraska, United States, 68131

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	B0041002
Study First Received:	July 24, 2008
Last Updated:	July 22, 2009
ClinicalTrials.gov Identifier:	NCT00723021 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Bronchodilator

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Zileuton

Lung Diseases
Hypersensitivity, Immediate
Asthma
Bronchodilator Agents
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on September 11, 2009