Back to resultsEffects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
Primary Purpose
Asthma
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
GW597901X
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring GW597901X, Asthma, Crossover, dose ascending, repeat dose, inhaled
Eligibility Criteria
Inclusion criteria: Subjects with mild to moderate stable asthma but no other lung problems. Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile). Non-Smokers. Subjects who 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 a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma. Subjects who take medication for their asthma, or other conditions, not compatible with this study. Subjects who are over sensitive to salbutamol or to ipratropium.
Sites / Locations
Outcomes
Primary Outcome Measures
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
Secondary Outcome Measures
Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354042
Brief Title
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
Official Title
A Randomised, Double-Blind, Placebo-Controlled, Dose Ascending, 4 Period Crossover Study to Examine the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Repeat Inhaled Doses of GW597901X in Asthmatic Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is designed to look at the safety aspects and effects of repeat inhaled doses of GW597901X in asthmatics to develop this drug for its use in asthma and Chronic Obstructive Pulmonary Disease(COPD).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
GW597901X, Asthma, Crossover, dose ascending, repeat dose, inhaled
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
24 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GW597901X
Primary Outcome Measure Information:
Title
Safety Tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and any side effects.
Secondary Outcome Measure Information:
Title
Effects on the lungs at 12 and 24 hours Effects on the heart, blood pressure and heart rate at 8 hours Effects on blood tests over 4 hours and 8 hours Reduction of rescue medication.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Subjects with mild to moderate stable asthma but no other lung problems.
Male subjects or female subjects who are not able to get pregnant (e.g. post-menopausal or surgically sterile).
Non-Smokers.
Subjects who 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 a cold or chest infection 2-4 weeks prior to the study or have life-threatening asthma.
Subjects who take medication for their asthma, or other conditions, not compatible with this study.
Subjects who are over sensitive to salbutamol or to ipratropium.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials, MD, MSc, FPPM
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Effects Of Repeat Inhaled Doses Of GW597901X On Patient Safety And Lung Function In Asthmatic Subjects
We'll reach out to this number within 24 hrs