Ignite Creation Date:
2024-05-06 @ 1:47 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01899768
Status:
COMPLETED
Last Update Posted:
2017-04-05
First Post:
2013-07-11
Brief Title:
GSK2339345 Hypertussive Challenge Study
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Double-Blind Sponsor-Unblind Placebo Controlled Cross-Over Study to Investigate the Efficacy Effect on Cough Reflex Sensitivity Safety Tolerability and Pharmacokinetics of Inhaled GSK2339345 in Patients With Chronic Idiopathic Cough Using an Aqueous Droplet Inhaler
Status:
COMPLETED
Status Verified Date:
2017-02
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 is designed to evaluate the effect of GSK2339345 relative to placebo on the number of coughs in patients with Chronic Idiopathic Cough CIC administered by an Aqueous Droplet Inhaler ADI The primary aim is to investigate the efficacy of GSK2339345 on reducing objective cough frequency in CIC patients The secondary aim of this study is to investigate the efficacy of GSK2339345 in inhibiting a hypertussive cough response elicited by capsaicin and citric acid in CIC patients which have a hyperresponsive cough reflex
Following the screening visit all eligible subjects will attend the unit for dosing at Visits 1-7 At Visits 1 2 and 3 Part A of the study subjects will receive two doses of either GSK2339345 or placebo 4 hours apart and will undergo 8 hours of cough monitoring At Visits 4 and 5 Part B of the study and Visits 6 and 7 Part C of the study subjects will be administered a single dose of either GSK2339345 or placebo Subjects will then undergo capsaicin Part B or citric acid Part C tussive challenge and will undergo cough monitoring for 1 hour post dose
The maximum study duration will be approximately 11 weeks including 3 weeks screening and 2 weeks follow-up Approximately 30 patients will be randomised into the study such that approximately 24 patients complete dosing and critical assessments
Following the screening visit all eligible subjects will attend the unit for dosing at Visits 1-7 At Visits 1 2 and 3 Part A of the study subjects will receive two doses of either GSK2339345 or placebo 4 hours apart and will undergo 8 hours of cough monitoring At Visits 4 and 5 Part B of the study and Visits 6 and 7 Part C of the study subjects will be administered a single dose of either GSK2339345 or placebo Subjects will then undergo capsaicin Part B or citric acid Part C tussive challenge and will undergo cough monitoring for 1 hour post dose
The maximum study duration will be approximately 11 weeks including 3 weeks screening and 2 weeks follow-up Approximately 30 patients will be randomised into the study such that approximately 24 patients complete dosing and critical assessments
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