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

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ClinicalTrials.gov Identifier: NCT00877539
Recruitment Status : Completed
First Posted : April 7, 2009
Last Update Posted : September 28, 2010
Sponsor:
Information provided by:
Pfizer

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

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
U.S. FDA Resources

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
Inhaled



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 ]


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

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 ClinicalTrials.gov identifier (NCT number): NCT00877539


Locations
United Kingdom
Pfizer Investigational Site
London, United Kingdom, SE1 1YR
Pfizer Investigational Site
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00877539     History of Changes
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:
Fluticasone
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