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A Study To Assess The Effect Of PF-03526299 On Lung Function Following An Allergen Challenge In Asthmatic Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00877539
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : September 28, 2010
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: PF-03526299 Drug: Placebo Drug: Fluticasone propionate Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : June 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Fluticasone

Arm Intervention/treatment
Experimental: PF-03526299 Drug: PF-03526299
Inhaled, two doses 4 hours apart

Placebo Comparator: Placebo Drug: Placebo
Inhaled, two doses 4 hours apart

Active Comparator: Fluticasone propionate Drug: Fluticasone propionate

Primary Outcome Measures :
  1. Spirometry pre- and post- bronchial allergen challenge [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Laboratory safety tests [ Time Frame: 2 months ]
  2. 12-lead ECGs [ Time Frame: 2 months ]
  3. Adverse Event reporting [ Time Frame: 2 months ]
  4. Blood samples for pharmacokinetic measurement [ Time Frame: 2 months ]
  5. Sputum for pharmacodynamic measurement [ Time Frame: 2 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00877539

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United Kingdom
Pfizer Investigational Site
London, United Kingdom, SE1 1YR
Pfizer Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00877539    
Other Study ID Numbers: A9291002
First Posted: April 7, 2009    Key Record Dates
Last Update Posted: September 28, 2010
Last Verified: September 2010
Keywords provided by Pfizer:
Asthma Allergen Challenge
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents