Asthma
Conditions
Keywords
GW642444 asthmatic subjects safety tolerability PD and PK
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.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FEV1 at 24 hours after a single dose. | 24 hours on 4 separate occasions |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| FEV1 - 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 |
| Potassium and glucose on Days 1 and 7 | Days 1 and 7 on 4 separate occasions |
Countries
Germany, Sweden
Outcome results
None listed