Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00381667
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2006-09-26
Brief Title:
Study to Assess GW642444 in Asthma Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Double-blind Placebo-controlled Dose Ascending Five-way Crossover Study to Examine Efficacy Safety Tolerability Pharmacodynamics and Pharmacokinetics of a Single Administration of Three Inhaled Doses 25 100 and 400 µg of GW642444M
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a study of GW642444M a long-acting beta 2 specific agonist This study will examine GW642444M via the inhaled route and will assess the efficacy safety tolerability pharmacodynamics and pharmacokinetics of a single administration of three inhaled doses 25 100 and 400 µg of GW642444M in persistent asthmatics This study will be a single-centre placebo-controlled dose-ascending five-way crossover in 30 asthmatic patients
Key assessments efficacy safety tolerability pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1 blood pressure pulse rate 12-lead ECGs clinical laboratory safety tests collection of adverse events and blood samples
Key assessments efficacy safety tolerability pharmacokinetics and pharmacodynamics will be assessed by measurement of FEV1 blood pressure pulse rate 12-lead ECGs clinical laboratory safety tests collection of adverse events and blood samples
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None