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OpenTrials
Completed

NCT Number: NCT00856687

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Harrow, Middlesex, HA1 3UJ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-03893787

Drug

Oral, two doses 12 hours apart

Placebo

Drug

Oral, two doses 12 hours apart

Montelukast

Drug

Oral, two doses 12 hours apart

Primary outcomes

  1. Spirometry pre- and post- bronchial allergen challenge

    Time frame: 2 months

Secondary outcomes

  1. Laboratory safety tests

    Time frame: 2 months

  2. 12-lead ECGs

    Time frame: 2 months

  3. Adverse Event reporting

    Time frame: 2 months

  4. Blood samples for pharmacokinetic measurement

    Time frame: 2 months

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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.

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Mar 6, 2009
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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