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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00856687
First received: March 5, 2009
Last updated: January 21, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: PF-03893787
Drug: Placebo
Drug: Montelukast
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 (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.

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 ]

Estimated Enrollment: 12
Study Start Date: April 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF-03893787 Drug: PF-03893787
Oral, two doses 12 hours apart
Placebo Comparator: Placebo Drug: Placebo
Oral, two doses 12 hours apart
Active Comparator: Montelukast Drug: Montelukast
Oral, two doses 12 hours apart

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856687

Locations
United Kingdom
Pfizer Investigational Site
Harrow, Middlesex, United Kingdom, HA1 3UJ
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: NCT00856687     History of Changes
Other Study ID Numbers: B0281002
Study First Received: March 5, 2009
Last Updated: January 21, 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
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014