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
  Purpose

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
Asthma
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
Inhaled

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 21, 2014