Investigation Of A New Medication (GW642444) In Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
This study will evaluate efficacy (FEV1), safety, tolerability, pharmacodynamics and pharmacokinetics of single and repeat inhaled doses of GW642444. This will be a multi-centre, double-blind, placebo controlled, dose ascending, four way cross-over study in approximately 28 mild to moderate asthmatic subjects. Key assessments: Efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics will be assessed by measurement of FEV1, blood pressure, heart rate, 12-lead ECGs, clinical laboratory tests, collection of adverse events (AE) information and blood samples.

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Placebo Controlled, Dose Ascending, Four Way Crossover Study to Examine Efficacy (FEV1), Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Doses of GW642444

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

Intervention / Treatment
-----------------
* Drug: GW642444
* Drug: Placebo
* Drug: salmeterol 50mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Female subjects must be non-childbearing (i.e., surgically sterilised or post-menopausal). Non-smokers for at least 6 months. Stable asthma. Exclusion criteria: Abnormal findings on heart monitoring assessment. Lower respiratory tract infection within 4 weeks, upper respiratory tract within 2 weeks of study. Currently taking doses of fluticasone propionate over 500mcg/day. Unstable asthma medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GW642444 50mcg<br> | Drug: GW642444<br>* drug<br>|
| Experimental: GW642444 100mcg<br> | Drug: GW642444<br>* drug<br>|
| Experimental: GW642444 200mcg<br> | Drug: GW642444<br>* drug<br>|
| Active Comparator: salmeterol 50mcg<br> | Drug: salmeterol 50mcg<br>* salmeterol<br>|
| Placebo Comparator: placebo<br> | Drug: Placebo<br>* placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 at 24 hours after a single dose. |  | 24 hours on 4 separate occasions | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 - Days 1 and 7 |  | Days 1 and 7 on 4 separate occasions | 
| Mean morning/evening PEFR |  | Days 3-8 on 4 separate occasions | 
| BP, HR & QTc on Days 1 and 7 |  | Days 1 and 7 on 4 separate occasions | 
| Potassium and glucose on Days 1 and 7 |  | Days 1 and 7 on 4 separate occasions | 
| safety & tolerability as measured by AEs, laboratory safety tests, cardiac monitoring, VS & ECG |  | throughout study | 
| PK parameters |  | Days 1, 4 and 7 on 4 separate occasions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GW642444 asthmatic subjects safety tolerability PD and PK