Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00354666

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: GSK159797	Phase II

MedlinePlus related topics: Asthma

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Crossover Assignment, Safety Study
Official Title:	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

Further study details as provided by GlaxoSmithKline:

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:	20
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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).
Non-smokers.
Subjects that show a measurable improvement in the function of their lungs after a single dose of salbutamol.

Exclusion criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354666

Locations

New Zealand
GSK Investigational Site
Wellington 6004, New Zealand, 6004

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	B2E101312
Study First Received:	July 18, 2006
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00354666
Health Authority:	New Zealand: Health and Disability Ethics Committees

Keywords provided by GlaxoSmithKline:

GSK159797
efficacy
safety and tolerability

inhaled
dry powder
asthmatic subjects

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Immune System Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on January 14, 2009