Back to resultsSingle Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
GSK159797
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring inhaled, asthmatic subjects, GSK159797, safety and tolerability, efficacy, dry powder
Eligibility 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.
Sites / Locations
Outcomes
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00354666
Brief Title
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
inhaled, asthmatic subjects, GSK159797, safety and tolerability, efficacy, dry powder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
GSK159797
Primary Outcome Measure Information:
Title
Safety and tolerability including blood test results, effects on the heart, pulse rate and blood pressure, and side effects.
Secondary Outcome Measure Information:
Title
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).
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E101312
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E101312
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E101312
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E101312
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E101312
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Single Doses GSK159797 On Patient Safety And Lung Function In Patients With Mild To Moderate Asthma
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