Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
This study has been completed.
Information provided by:
First received: July 18, 2006
Last updated: October 1, 2010
Last verified: October 2010
This study was designed to test safety aspects and effects on lung function of a new dry powder version of GSK159797 for asthmatic subjects to inhale. This will allow comparison with previous studies which have only used inhalation of the drug as a vapour.
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
||A Randomised, Double-blind, Placebo-controlled, Dose Ascending Crossover Study to Assess the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Inhaled GSK159797 Delivered by Dry Powder Inhaler in Mild to Moderate Asthmatic Subjects
Primary Outcome Measures:
- Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.
Secondary Outcome Measures:
- Effects on the lung at 12 and 24hrs Effects on the heart, blood pressure and pulse rate at 8hrs Changes in the amount of glucose and potassium in the blood 4 and 8hrs Amount of drug in the body (blood and urine).
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2004 (Final data collection date for primary outcome measure)
Other Name: GSK159797
|Ages Eligible for Study:
||18 Years to 65 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Subjects with mild to moderate stable asthma but no other lung problems.
- Male subjects or females who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
- Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol.
- Any significant illness.
- Subjects with heart problems.
- Subjects who have had a cold or chest infection 2-4 weeks prior to the study.
- Subjects who take medication for their asthma, or other conditions, not compatible with the study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00354666
||GSK Clinical Trials, MD
No publications provided
||Study Director, GSK
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 18, 2006
||October 1, 2010
||New Zealand: Health and Disability Ethics Committees
Keywords provided by GlaxoSmithKline:
safety and tolerability
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 23, 2013
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases