Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00519376
Status:
COMPLETED
Last Update Posted:
2017-03-23
First Post:
2007-08-21
Brief Title:
A Study To Investigate The Effect Of Inhaling A Single Dose Of GW642444M In COPD Patients
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Randomised Single-dose Dose Ascending Double-blind Placebo Controlled Four-way Incomplete Block Crossover Study to Investigate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Inhaled Doses of GW642444M With Magnesium Stearate in COPD Patients
Status:
COMPLETED
Status Verified Date:
2016-12
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 involve the use of a new compound GW642444 that is being developed for the treatment of asthma and chronic obstructive pulmonary disease COPD It works by acting on cells in the lungs causing some of the muscles around the lungs to relax and open up better bronchodilation making breathing easier When a medicine is made into a form ready to be given to patients the active ingredient is often prepared in the form of a salt and inactive ingredients excipients are often added Inactive ingredients might be used to help a medicine work better to make it easier to produce the medicine or to make it easier to get an accurate dose of medicine In previous studies the study drug has been given as a dry powder in the form of either the H salt with the excipient lactose or in the form of the M salt with the excipients lactose and cellobiose octaacetate In this study the M salt form of the study drug has been prepared with lactose and a new excipient called magnesium stearate instead of cellobiose octaacetate Participants in this study will receive both the H salt GW642444H and the new M salt GW642444M containing magnesium stearate This study will be the first time the new M salt form of the study drug will be given to COPD patients
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