Back to resultsStudy Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GSK159797 (10, 15, and 20mcg)
salbutamol
salmeterol 50mcg
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Safety, Asthmatic patients, GSK159797, Efficacy
Eligibility Criteria
Inclusion criteria: Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid Female subjects only using acceptable birth control method Non-smokers FEV1 between 60 and 90% predicted Increase in FEV1 12% or greater and 300mL and greater after salbutamol use Exclusion criteria: Past or present disease conditions Normal screening Holter ECG Respiratory tract infection within 4 weeks of screening History of life threatening asthma Previous use of COA
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
GSK159797 (10, 15, and 20mcg)
salbutamol
salmeterol 50mcg
placebo
Arm Description
GSK159797 (10, 15, and 20mcg)
salbutamol
salmeterol 50mcg
placebo
Outcomes
Primary Outcome Measures
Mean change from baseline in trough FEV1
Secondary Outcome Measures
Mean change from baseline in trough FEV1
Mean change from baseline in trough FEV1
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00358488
Brief Title
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
Official Title
A Multi-enter, Randomized, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (10, 15, and 20 mcg) of GSK159797
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is designed to determine the efficacy and safety of a new long-acting beta-agonist for asthma patients (GSK159797) following dosing for 14 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Safety, Asthmatic patients, GSK159797, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
54 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK159797 (10, 15, and 20mcg)
Arm Type
Experimental
Arm Description
GSK159797 (10, 15, and 20mcg)
Arm Title
salbutamol
Arm Type
Experimental
Arm Description
salbutamol
Arm Title
salmeterol 50mcg
Arm Type
Experimental
Arm Description
salmeterol 50mcg
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
GSK159797 (10, 15, and 20mcg)
Intervention Description
GSK159797 (10, 15, and 20mcg)
Intervention Type
Drug
Intervention Name(s)
salbutamol
Intervention Description
salbutamol
Intervention Type
Drug
Intervention Name(s)
salmeterol 50mcg
Intervention Description
salmeterol 50mcg
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
GSK159797 (10, 15, and 20mcg), salbutamol, salmeterol 50mcg
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Mean change from baseline in trough FEV1
Time Frame
after 14 day repeat doses
Secondary Outcome Measure Information:
Title
Mean change from baseline in trough FEV1
Time Frame
after a single dose
Title
Mean change from baseline in trough FEV1
Time Frame
after 7 days repeat dosing
Title
Change from baseline in weighted mean FEV1 0-2 hours, 0-4 hours, 0-24 hours
Time Frame
Day 1 and Day 14
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Subjects with documented history of persistent asthma using corticosteroids at a total daily dose of 200 to 200mcg of FP or equivalent corticosteroid
Female subjects only using acceptable birth control method
Non-smokers
FEV1 between 60 and 90% predicted
Increase in FEV1 12% or greater and 300mL and greater after salbutamol use
Exclusion criteria:
Past or present disease conditions
Normal screening Holter ECG
Respiratory tract infection within 4 weeks of screening
History of life threatening asthma
Previous use of COA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Wiesbaden
State/Province
Hessen
ZIP/Postal Code
65187
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
GSK Investigational Site
City
Utrecht
ZIP/Postal Code
3584 CJ
Country
Netherlands
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Lund
ZIP/Postal Code
SE-221 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E106359
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E106359
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E106359
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2E106359
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
B2E106359
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
B2E106359
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
B2E106359
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Study Investigating Repeat Doses Of A New Medication (GSK159797) In Asthmatic Patients
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