Ignite Creation Date:
2024-05-05 @ 10:40 PM
Last Modification Date:
2024-10-26 @ 10:22 AM
Study NCT ID:
NCT01160224
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2010-06-10
Brief Title:
Oral GW766944 Oral CCR3 Antagonist
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Parallel Group Study to Compare GW766944 an Oral CCR3 Receptor Antagonist Versus Placebo in Patients With Asthma and Sputum Eosinophilia
Status:
COMPLETED
Status Verified Date:
2017-04
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:
GW766994 is a selective competitive antagonist of the human CC chemokine receptor-3 CCR3 It is proposed that the inhibition of the CCR3 receptor may provide a treatment for airway inflammation such as in asthma This will be a double-blind placebo controlled parallel group study being conducted to evaluate the effects of GW766994 in subjects with mild-moderate asthma who have high sputum eosinophilia The primary objective is to compare the effects of GW766994 to placebo on sputum eosinophils
Detailed Description:
This will be a multi-centre study This is a randomized double-blind placebo-controlled parallel-group study in patients with asthma and eosinophilic bronchitis Subjects with asthma will be atopic and not on oral prednisone Inhaled corticosteroids are allowed if on stable dose All subjects will receive a 5 day course of 30mg daily of oral prednisone after one week stopping study drug
All subjects will attend screening Visit 1 at which their eligibility for inclusion will be assessed Eligible subjects will be randomized to receive either 300 mg of GW766994 twice daily or matching placebo at Day 1 Visit 2 and will be stratified according to the subjects sputum eosinophil count at Visit 1 Treatment will be 10 days of oral dosing and subjects will participate in a Day 7 or 8 visit Visit 3 Day 10 visit Visit 4 - End of Treatment followed by a 1 week wash out period Visit 5 -Follow Up Visit At Visit 5 all subjects will be given 30 mg oral daily prednisone for 5 days and subjects to return to clinic at a Post Oral Prednisone Visit Visit 6 at Day 22
Pharmacodynamic assessments will include both sputum and blood biomarkers and spirometry
Safety will be assessed by vital sign measurement electrocardiogram clinical laboratory tests hematology chemistry urinalysis clinical monitoring and adverse event reporting Pharmacokinetic samples will be collected from each subject according to the sample schedule in the timing and events table
Study will involved sputum biology progenitors cell counts Study will be conducted in Canada only
All subjects will attend screening Visit 1 at which their eligibility for inclusion will be assessed Eligible subjects will be randomized to receive either 300 mg of GW766994 twice daily or matching placebo at Day 1 Visit 2 and will be stratified according to the subjects sputum eosinophil count at Visit 1 Treatment will be 10 days of oral dosing and subjects will participate in a Day 7 or 8 visit Visit 3 Day 10 visit Visit 4 - End of Treatment followed by a 1 week wash out period Visit 5 -Follow Up Visit At Visit 5 all subjects will be given 30 mg oral daily prednisone for 5 days and subjects to return to clinic at a Post Oral Prednisone Visit Visit 6 at Day 22
Pharmacodynamic assessments will include both sputum and blood biomarkers and spirometry
Safety will be assessed by vital sign measurement electrocardiogram clinical laboratory tests hematology chemistry urinalysis clinical monitoring and adverse event reporting Pharmacokinetic samples will be collected from each subject according to the sample schedule in the timing and events table
Study will involved sputum biology progenitors cell counts Study will be conducted in Canada only
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None