A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00877539
First received: April 6, 2009
Last updated: September 27, 2010
Last verified: September 2010
Tracking Information | |||||
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First Received Date ICMJE | April 6, 2009 | ||||
Last Updated Date | September 27, 2010 | ||||
Start Date ICMJE | June 2009 | ||||
Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Spirometry pre- and post- bronchial allergen challenge [ Time Frame: 2 months ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00877539 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects | ||||
Official Title ICMJE | A Randomized, Double-Blind, Double-Dummy, Placebo Controlled, 3-Way Crossover Study To Determine The Effects Of Inhaled Doses Of PF-03526299 On Allergen-Induced Airway Responses In Mild Asthmatic Subjects. | ||||
Brief Summary | PF-03526299, 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. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Asthma | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 29 | ||||
Completion Date | July 2010 | ||||
Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 60 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United Kingdom | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00877539 | ||||
Other Study ID Numbers ICMJE | A9291002 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | ||||
Study Sponsor ICMJE | Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Pfizer | ||||
Verification Date | September 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |