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Study With GW274150 In Patients With Mild Asthma

Phase 1
Completed
Conditions
Asthma
Interventions
Registration Number
NCT00273013
Lead Sponsor
GlaxoSmithKline
Brief Summary

This is a study investigating whether 14 days of dosing with GW274150 has a beneficial effect on a model of asthma type inflammation called the allergen-induced late asthmatic response. This will be compared with the response after treatment with a dummy (placebo) and a tablet treatment for asthma called Singulair (montelukast). Subjects in the study will receive all 3 treatments in a random order. The study is double-blind so subjects will not know which treatment they are taking at any given time.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
28
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Sequence 2SingulairSubjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Sequence 1GW274150Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Sequence 1PlaceboSubjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Sequence 2GW274150Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Sequence 2PlaceboSubjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Sequence 3GW274150Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Sequence 3PlaceboSubjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Sequence 4GW274150Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Sequence 4PlaceboSubjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Sequence 5GW274150Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Sequence 5SingulairSubjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Sequence 5PlaceboSubjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Sequence 6GW274150Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.
Sequence 6PlaceboSubjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.
Sequence 1SingulairSubjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Sequence 3SingulairSubjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Sequence 4SingulairSubjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Sequence 6SingulairSubjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.
Primary Outcome Measures
NameTimeMethod
Effect on the late asthmatic reaction following an inhaled allergen challengeUp to Day 115
Secondary Outcome Measures
NameTimeMethod
Measures of safety. Measures of lung functionUp to Day 115

Trial Locations

Locations (1)

GSK Investigational Site

🇬🇧

London, United Kingdom

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