Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00422604
Status:
COMPLETED
Last Update Posted:
2016-10-28
First Post:
2007-01-15
Brief Title:
Safety And Efficacy Of GSK233705 Plus Salmeterol Compared With 2 Active Comparators And Placebo In Subjects With Chronic Obstructive Pulmonary Disease COPD
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Multicentre Randomised Partially Blinded Placebo-controlled Three-way Crossover Incomplete Block Design Study to Investigate the Safety Tolerability Pharmacodynamics Efficacy and Pharmacokinetics of Dual Bronchodilator Therapy With Salmeterol 50µg Twice-daily Plus Two Different Doses of GSK233705B 20 and 50µg Twice-daily Compared With Placebo Salmeterol 50µg Twice-daily Alone and Tiotropium 18µg Once-daily Alone in Subjects With Chronic Obstructive Pulmonary Disease
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:
The safety tolerability pharmacokinetics and pharmacodynamicsefficacy profiles of two different doses of GSK233705 will be compared with 2 active comparators and placebo all medication delivered via dry powder inhaler
Detailed Description:
A multi-centre randomised partially blinded placebo-controlled three-way crossover incomplete block design study to investigate the safety tolerability pharmacodynamicsefficacy and pharmacokinetics of dual bronchodilator therapy with salmeterol 50 mcg twice daily plus two different doses of GSK233705 20 and 50 mcg twice daily compared with placebo salmeterol 50 mcg twice daily alone and tiotropium 18 mcg once daily alone in subjects with chronic obstructive pulmonary disease
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