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

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NCT00856687

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Study Location
Pfizer Investigational Site
Harrow, Middlesex, HA1 3UJ, United Kingdom
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Contact
1-800-718-1021
[email protected]om
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Asthma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-60 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Males and females 18-60 years.

- Mild asthma

- Atopic to allergens

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Unstable asthma.


- Smokers or recent ex-smokers


- Recent allergen challenge

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study To Assess The Effect Of PF-03893787 On Lung Function Following An Allergen Challenge In Asthmatic Subjects
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • 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 Arms  ICMJE
  • Experimental: PF-03893787
    Intervention: Drug: PF-03893787
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Active Comparator: Montelukast
    Intervention: Drug: Montelukast
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: March 5, 2009)		12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00856687
Other Study ID Numbers  ICMJE B0281002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date January 2010

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