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

This study has been completed.
Information provided by:
ClinicalTrials.gov Identifier:
First received: April 6, 2009
Last updated: September 27, 2010
Last verified: September 2010
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 Intervention Phase
Drug: PF-03526299
Drug: Placebo
Drug: Fluticasone propionate
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Spirometry pre- and post- bronchial allergen challenge [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 29
Study Start Date: June 2009
Study Completion Date: July 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00877539

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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00877539     History of Changes
Other Study ID Numbers: A9291002 
Study First Received: April 6, 2009
Last Updated: September 27, 2010
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Pfizer:
Asthma Allergen Challenge

Additional relevant MeSH terms:
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents

ClinicalTrials.gov processed this record on May 24, 2016