Study With GW274150 In Patients With Mild Asthma

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.

Official Title
-----------------
Single Centre Allergen Challenge Study of GW274150 in Mild Asthmatic Subjects

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: GW274150
* Drug: Singulair
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Mild asthma: taking reliever medication (e.g. salbutamol) only. Screening involves measuring responses to the lung challenge agents: allergen, AMP, and methacholine. Only those with specific types of response to these will be eligible for the study. Exclusion criteria: Recent steroid treatment. Significant illnesses or diseases other than asthma.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Subjects will receive Placebo in period 1, Singulair 10 milligrams (mg) in period 2 and GW274150 90 mg in period 3. | Drug: GW274150<br>* GW274150 will be available as 30 mg white oval tablets.<br>Drug: Singulair<br>* Singulair will be available as over encapsulated 10 mg orange tablets.<br>* Other names: GW274150;Drug: Placebo<br>* Matching placebo for Singulair and GW274150 will be available.<br>|
| Experimental: Sequence 2<br>Subjects will receive Placebo in period 1, GW274150 90 mg in period 2 and Singulair 10 mg in period 3. | Drug: GW274150<br>* GW274150 will be available as 30 mg white oval tablets.<br>Drug: Singulair<br>* Singulair will be available as over encapsulated 10 mg orange tablets.<br>* Other names: GW274150;Drug: Placebo<br>* Matching placebo for Singulair and GW274150 will be available.<br>|
| Experimental: Sequence 3<br>Subjects will receive Singulair 10 mg in period 1, Placebo in period 2 and GW274150 90 mg in period 3. | Drug: GW274150<br>* GW274150 will be available as 30 mg white oval tablets.<br>Drug: Singulair<br>* Singulair will be available as over encapsulated 10 mg orange tablets.<br>* Other names: GW274150;Drug: Placebo<br>* Matching placebo for Singulair and GW274150 will be available.<br>|
| Experimental: Sequence 4<br>Subjects will receive Singulair 10 mg in period 1, GW274150 90 mg in period 2 and Placebo in period 3. | Drug: GW274150<br>* GW274150 will be available as 30 mg white oval tablets.<br>Drug: Singulair<br>* Singulair will be available as over encapsulated 10 mg orange tablets.<br>* Other names: GW274150;Drug: Placebo<br>* Matching placebo for Singulair and GW274150 will be available.<br>|
| Experimental: Sequence 5<br>Subjects will receive GW274150 90 mg in period 1, Placebo in period 2 and Singulair 10 mg in period 3. | Drug: GW274150<br>* GW274150 will be available as 30 mg white oval tablets.<br>Drug: Singulair<br>* Singulair will be available as over encapsulated 10 mg orange tablets.<br>* Other names: GW274150;Drug: Placebo<br>* Matching placebo for Singulair and GW274150 will be available.<br>|
| Experimental: Sequence 6<br>Subjects will receive GW274150 90 mg in period 1, Singulair 10 mg in period 2 and Placebo in period 3. | Drug: GW274150<br>* GW274150 will be available as 30 mg white oval tablets.<br>Drug: Singulair<br>* Singulair will be available as over encapsulated 10 mg orange tablets.<br>* Other names: GW274150;Drug: Placebo<br>* Matching placebo for Singulair and GW274150 will be available.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect on the late asthmatic reaction following an inhaled allergen challenge |  | Up to Day 115 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measures of safety. Measures of lung function |  | Up to Day 115 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, allergen challenge