Examine the Effect of Repeat Inhaled Doses of GW870086X on Lung Function in Mild Asthmatic Male Subjects

Study Overview
=================
Brief Summary
-----------------
This study was designed to look at safety aspects and effects of repeat inhaled doses of GW870086X in mild asthmatics to develop this drug for its use in asthma and chronic obstructive pulmonary disease (COPD)

Official Title
-----------------
Double-blind, Placebo-controlled, 3-way Crossover Study to Investigate the Effect of 7-days Repeat Once Daily Inhaled Doses of GW870086X Administered Via DISKHALER on Airway Responsiveness to AMP in Mild Steroid-naive Male Asthmatics

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

Intervention / Treatment
-----------------
* Drug: GW870086X
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Male subjects aged 18-55 Documented history of bronchial asthma diagnosed at least 6 months ago. Only being treated with short-acting beta-2-agonist therapy e.g. Ventolin Documented sensitivity to adenosine mono phosphate (AMP) at screening visit Demonstrate repeatable and reproducable response to inhaled AMP at the run-in visit Exclusion criteria: Any significant illness or disease History of life threatening asthma History of respiratory tract infection Subjects who take medication for their asthma, or other conditions, not compatible with this study. Smoker Subjects who are oversensitive to corticosteroids History of drug or alcohol abuse Donated blood within last 3 months Been involved in another clinical trial during the last 3 months Subjects who work night shifts Subjects who are undergoing de-sensitisation therapy

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1: Part A<br>Subjects in Cohort 1 will be randomized to receive 0.5, 2 and 6 mg GW870086X and placebo. | Drug: GW870086X<br>* Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times<br>Drug: Placebo<br>* Placebo matching GW870086X will be administered by subjects<br>|
| Experimental: Cohort 2: Part A<br>Subjects in Cohort 2 will be randomized to receive 3 mg GW870086X or placebo. | Drug: GW870086X<br>* Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times<br>Drug: Placebo<br>* Placebo matching GW870086X will be administered by subjects<br>|
| Experimental: Part B<br>Subjects will be randomized to receive 1 and 3 mg of GW870086X or placebo. | Drug: GW870086X<br>* Subjects will inhale 0.25 or 1.5 mg/inhalation GW870086X for four times<br>Drug: Placebo<br>* Placebo matching GW870086X will be administered by subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function 2 hours after treatment on day 7 |  | on day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lung function 14 and 26 hours after treatment on day 7; Change in lung function 2 hours after treatment on day 1; Effects on blood and urine tests; effects on the heart, pulse rate and blood pressure; effects on the lungs |  | 2 hours after treatment on day 1, 14 and 26 hours after treatment on day 7; | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW870086X Asthma Crossover repeat dose inhaled