Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00877539
First received: April 6, 2009
Last updated: September 27, 2010
Last verified: September 2010

April 6, 2009
September 27, 2010
June 2009
December 2009   (final data collection date for primary outcome measure)
Spirometry pre- and post- bronchial allergen challenge [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00877539 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Sputum for pharmacodynamic measurement [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
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.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
  • Drug: PF-03526299
    Inhaled, two doses 4 hours apart
  • Drug: Placebo
    Inhaled, two doses 4 hours apart
  • Drug: Fluticasone propionate
    Inhaled
  • Experimental: PF-03526299
    Intervention: Drug: PF-03526299
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Fluticasone propionate
    Intervention: Drug: Fluticasone propionate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
July 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00877539
A9291002
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP