Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354874
Status:
COMPLETED
Last Update Posted:
2016-09-15
First Post:
2006-07-18
Brief Title:
Investigation Of A New Medication GW642444 In Asthmatic Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-09
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 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
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
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