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

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.

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00856687
Enrollment
12
Registered
2009-03-06
Start date
2009-04-30
Completion date
2009-12-31
Last updated
2010-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Asthma Allergen Challenge

Brief summary

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.

Interventions

DRUGPF-03893787

Oral, two doses 12 hours apart

DRUGPlacebo

Oral, two doses 12 hours apart

DRUGMontelukast

Oral, two doses 12 hours apart

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Spirometry pre- and post- bronchial allergen challenge2 months

Secondary

MeasureTime frame
Laboratory safety tests2 months
12-lead ECGs2 months
Adverse Event reporting2 months
Blood samples for pharmacokinetic measurement2 months

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026