Back to resultsRepeat Doses Of A New Medication (GW642444) In Asthmatic Patients
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GW642444 (25, 100 & 400 mcg/day)
Salmeterol 50mcg
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Tolerability, Pharmacodynamics, Safety, Pharmacokinetics, GW642444, Asthmatic patients, Efficacy
Eligibility Criteria
Inclusion criteria: Subjects with a documented history of persistent asthma. Current non-smokers. Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values. Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent. Exclusion criteria: Subjects with significant past or present disease which which may affect their safety. Upper or lower respiratory tract infection within 4 weeks of screening. History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study. Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study. Patients weighing less than 50kg.
Sites / Locations
- GSK Investigational Site
- 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 Type
Experimental
Active Comparator
Arm Label
GW642444
Salmeterol
Arm Description
Outcomes
Primary Outcome Measures
Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days
The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.
Secondary Outcome Measures
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose value recorded on Day 1. Weighted means have been presented as least square means. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient.
Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline AM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM FEV1 values were measured by electronic flow meter and was measured in the morning over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline AM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM FEV1 values were measured by electronic flow meter and was measured in the evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-AM PEFR is the value at indicated time point minus the pre-AM PEFR value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period.
Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-PM PEFR is the value at indicated time point minus the pre-PM PEFR value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each morning, over period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00347139
Brief Title
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
Official Title
Multi-centre, Randomised, 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 (25, 100 and 400 mcg Once Daily) of GW642444
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
May 23, 2006 (Actual)
Primary Completion Date
January 10, 2007 (Actual)
Study Completion Date
January 10, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
Tolerability, Pharmacodynamics, Safety, Pharmacokinetics, GW642444, Asthmatic patients, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GW642444
Arm Type
Experimental
Arm Title
Salmeterol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GW642444 (25, 100 & 400 mcg/day)
Intervention Description
25, 100 and 400mcg/dose
Intervention Type
Drug
Intervention Name(s)
Salmeterol 50mcg
Intervention Description
Salmeterol 50mcg
Primary Outcome Measure Information:
Title
Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days
Description
The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.
Time Frame
From Baseline (pre-dose on Day 1) and up to 14 days
Secondary Outcome Measure Information:
Title
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose value recorded on Day 1. Weighted means have been presented as least square means. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient.
Time Frame
From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
Title
Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline AM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Time Frame
Baseline (pre-dose on Day 1) and up to 15 days
Title
Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Time Frame
Baseline (pre-dose on Day 1) and up to 14 days
Title
Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM FEV1 values were measured by electronic flow meter and was measured in the morning over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline AM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Time Frame
Baseline (pre-dose on Day 1), Day 2, and Day 15
Title
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM FEV1 values were measured by electronic flow meter and was measured in the evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.
Time Frame
Baseline (pre-dose on Day 1) and up to Day 14
Title
Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-AM PEFR is the value at indicated time point minus the pre-AM PEFR value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period.
Time Frame
Day 1, 7, and 14
Title
Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
Description
The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-PM PEFR is the value at indicated time point minus the pre-PM PEFR value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each morning, over period.
Time Frame
Day 1, 7, and 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Subjects with a documented history of persistent asthma.
Current non-smokers.
Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.
Exclusion criteria:
Subjects with significant past or present disease which which may affect their safety.
Upper or lower respiratory tract infection within 4 weeks of screening.
History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have changed therapy within 8 weeks of the study.
Patients weighing less than 50kg.
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
Grosshansdorf
State/Province
Schleswig-Holstein
ZIP/Postal Code
22927
Country
Germany
Facility Name
GSK Investigational Site
City
Wellington
ZIP/Postal Code
6035
Country
New Zealand
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
105 077
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Göteborg
ZIP/Postal Code
SE-413 45
Country
Sweden
Facility Name
GSK Investigational Site
City
Stockholm
ZIP/Postal Code
SE-141 86
Country
Sweden
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE5 9RJ
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
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
B2C106093
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
B2C106093
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
B2C106093
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
B2C106093
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
B2C106093
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
B2C106093
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
B2C106093
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
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