Ignite Creation Date:
2024-05-05 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00372112
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2006-09-04
Brief Title:
A Study To Assess The Safety And Tolerability Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A 2-wk Study to Evaluate the Safety TolerabilityPharmacodynamics and Pharmacokinetics of GW642444H100 Administered Once Daily in the Morning Via DISKUS Dry-powder InhalerCompared With SEREVENTSalmeterol50mcg Administered Twice Daily Via DISKUS Dry-powder Inhalerand Placebo in Subject wCOPD
Status:
COMPLETED
Status Verified Date:
2018-03
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:
The compound GW642444 has previously been found to be well tolerated with no significant side effects in subjects with asthma and healthy volunteers This study will assess the safety and tolerability of GW642444 in subjects with COPD in order to obtain information to support dosing in a broader population of subjects with COPD
Detailed Description:
A multicentre randomised placebo-controlled double-blind 4-arm parallel-group 2-week study to evaluate the safety tolerability pharmacodynamics and pharmacokinetics of GW642444H 100 administered once daily in the morning via DISKUS dry-powder inhaler compared with SEREVENT salmeterol 50mcg administered twice daily via DISKUS dry-powder inhaler and placebo in subjects with moderate COPD
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