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NCT00877539 Clinical Trial

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

Asthma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00877539
Other study ID # A9291002
Secondary ID
Status Completed
Phase Phase 1
First received April 6, 2009
Last updated September 27, 2010
Start date June 2009
Est. completion date July 2010

Study information
Verified date September 2010
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date July 2010
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PF-03526299
Inhaled, two doses 4 hours apart
• Placebo
Inhaled, two doses 4 hours apart
• Fluticasone propionate
Inhaled

Locations
Country Name City State
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Manchester

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spirometry pre- and post- bronchial allergen challenge 2 months No
Secondary Laboratory safety tests 2 months Yes
Secondary 12-lead ECGs 2 months Yes
Secondary Adverse Event reporting 2 months Yes
Secondary Blood samples for pharmacokinetic measurement 2 months No
Secondary Sputum for pharmacodynamic measurement 2 months No
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