Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- GlaxoSmithKline
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Effect on the late asthmatic reaction following an inhaled allergen challenge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Sequence 1
Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Intervention: GW274150 (Drug)
Sequence 1
Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Intervention: Singulair (Drug)
Sequence 1
Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3.
Intervention: Placebo (Drug)
Sequence 2
Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Intervention: GW274150 (Drug)
Sequence 2
Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Intervention: Singulair (Drug)
Sequence 2
Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3.
Intervention: Placebo (Drug)
Sequence 3
Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Intervention: GW274150 (Drug)
Sequence 3
Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Intervention: Singulair (Drug)
Sequence 3
Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3.
Intervention: Placebo (Drug)
Sequence 4
Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Intervention: GW274150 (Drug)
Sequence 4
Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Intervention: Singulair (Drug)
Sequence 4
Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3.
Intervention: Placebo (Drug)
Sequence 5
Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Intervention: GW274150 (Drug)
Sequence 5
Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Intervention: Singulair (Drug)
Sequence 5
Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3.
Intervention: Placebo (Drug)
Sequence 6
Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.
Intervention: GW274150 (Drug)
Sequence 6
Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.
Intervention: Singulair (Drug)
Sequence 6
Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Effect on the late asthmatic reaction following an inhaled allergen challenge
Time Frame: Up to Day 115
Secondary Outcomes
- Measures of safety. Measures of lung function(Up to Day 115)