A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects | RxWiki

A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

Overview[ - collapse ][ - ]

Purpose	PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.
Condition	Asthma
Intervention	Drug: PF-03893787 Drug: Placebo Drug: Montelukast
Phase	Phase 1
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00856687
First Received	March 5, 2009
Last Updated	January 21, 2010
Last verified	January 2010

Tracking Information[ + expand ][ + ]

First Received Date	March 5, 2009
Last Updated Date	January 21, 2010
Start Date	April 2009
Estimated Primary Completion Date	December 2009
Current Primary Outcome Measures	Spirometry pre- and post- bronchial allergen challenge [Time Frame: 2 months] [Designated as safety issue: No]
Current Secondary Outcome Measures	Laboratory safety tests [Time Frame: 2 months] [Designated as safety issue: Yes] 12-lead ECGs [Time Frame: 2 months] [Designated as safety issue: Yes] Adverse Event reporting [Time Frame: 2 months] [Designated as safety issue: Yes] Blood samples for pharmacokinetic measurement [Time Frame: 2 months] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
Official Title	A Randomized, Double-Blind (3rd Party Open), Double-Dummy, Placebo- And Active Controlled, 3-Way Crossover Study To Determine The Effects Of Oral PF-03893787 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects.
Brief Summary	PF-03893787, a novel anti-inflammatory agent should attenuate the effect of a bronchial allergen challenge on lung function and hence provide proof of mechanism for this agent.
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 1
Study Design	Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Asthma
Intervention	Drug: PF-03893787 Oral, two doses 12 hours apart Drug: Placebo Oral, two doses 12 hours apart Drug: Montelukast Oral, two doses 12 hours apart
Study Arm (s)	Experimental: PF-03893787 Placebo Comparator: Placebo Active Comparator: Montelukast

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	12
Estimated Completion Date	December 2009
Estimated Primary Completion Date	December 2009
Eligibility Criteria	Inclusion Criteria: - Males and females 18-60 years. - Mild asthma - Atopic to allergens Exclusion Criteria: - Unstable asthma. - Smokers or recent ex-smokers - Recent allergen challenge
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number	NCT00856687
Other Study ID Numbers	B0281002
Has Data Monitoring Committee	No
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Not Provided
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	January 2010

Locations[ + expand ][ + ]