Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
GlaxoSmithKline |
---|---|
Information provided by: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00783003 |
GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary Disease. Development of these two inhaled drugs as a combination therapy would have potential for improved patient benefit as they both work through different mechanisms and the combined bronchodilatory effect might be additive. This study will look at the this combination, for the first time, in healthy Japanese subjects.
Condition | Intervention | Phase |
---|---|---|
Healthy Subjects Healthy Volunteer |
Drug: GW642444 Drug: GSK233705 and GW642444 Drug: Placebo Drug: GSK233705 |
Phase I |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment, Safety/Efficacy Study |
Official Title: | A Single Centre, Randomised, Placebo-Controlled, Four-Way Cross Over Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single Inhaled Doses of GSK233705 and GW642444 as Monotherapies and in Combination in Healthy Japanese Subjects |
Estimated Enrollment: | 16 |
Study Start Date: | November 2008 |
Estimated Study Completion Date: | December 2008 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Placebo: Placebo Comparator
Matching placebo, no intervention.
|
Drug: Placebo
Matching placebo.
|
LAMA with LABA: Experimental
Inhaled Long Acting Muscarinic receptor Antagonist (LAMA) and a inhaled Long Acting Beta 2 Agonist (LABA), both in development for treatment of Chronic Obstructive Pulmonary Disease and taken in combination.
|
Drug: GSK233705 and GW642444
Inhaled Long acting muscarinic receptor antagonist (LAMA) and a inhaled Long acting Beta 2 agonist (LABA) both in development as treatment for Chronic Obstructive Pulmonary Disease, taken in combination.
|
Long acting Beta 2 agonist (LABA): Experimental
Inhaled Long Acting Beta 2 agonist (LABA) which is in development as a treatment for Chronic Obstructive Pulmonary Disease.
|
Drug: GW642444
Inhaled Long acting Beta 2 agonist (LABA)
|
Long acting muscarinic receptor antagonist (LAMA): Experimental
Inhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease.
|
Drug: GSK233705
Inhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease.
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: US GSK Clinical Trials Call Center | 877-379-3718 |
United Kingdom | |
GSK Investigational Site | Recruiting |
Stepney Green, United Kingdom, E1 4NL |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GSK ( Study Director ) |
Study ID Numbers: | 112146, DB1112146 |
Study First Received: | October 30, 2008 |
Last Updated: | November 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00783003 |
Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Muscarinic Receptor Antagonist, Anticholinergic Anticholinergic ß2 agonist |
Safety Tolerability Pharmacokinetics |
Naphazoline Oxymetazoline Guaifenesin |
Phenylephrine Phenylpropanolamine Healthy |