- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00347139
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
September 12, 2017 updated by: GlaxoSmithKline
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
55
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hessen
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Wiesbaden, Hessen, Germany, 65187
- GSK Investigational Site
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Schleswig-Holstein
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Grosshansdorf, Schleswig-Holstein, Germany, 22927
- GSK Investigational Site
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Wellington, New Zealand, 6035
- GSK Investigational Site
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Moscow, Russian Federation, 105 077
- GSK Investigational Site
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Göteborg, Sweden, SE-413 45
- GSK Investigational Site
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Stockholm, Sweden, SE-141 86
- GSK Investigational Site
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London, United Kingdom, SE5 9RJ
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: GW642444
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25, 100 and 400mcg/dose
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Active Comparator: Salmeterol
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Salmeterol 50mcg
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
Time Frame: From Baseline (pre-dose on Day 1) and up to 14 days
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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.
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From Baseline (pre-dose on Day 1) and up to 14 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
Time Frame: From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
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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.
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From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14
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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
Time Frame: Baseline (pre-dose on Day 1) and up to 15 days
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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.
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Baseline (pre-dose on Day 1) and up to 15 days
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Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14
Time Frame: Baseline (pre-dose on Day 1) and up to 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 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.
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Baseline (pre-dose on Day 1) and up to 14 days
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Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
Time Frame: Baseline (pre-dose on Day 1), Day 2, and Day 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.
|
Baseline (pre-dose on Day 1), Day 2, and Day 15
|
Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
Time Frame: Baseline (pre-dose on Day 1) and up to 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.
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.
|
Baseline (pre-dose on Day 1) and up to Day 14
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Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
Time Frame: Day 1, 7, and 14
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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.
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Day 1, 7, and 14
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Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
Time Frame: Day 1, 7, and 14
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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.
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Day 1, 7, and 14
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2006
Primary Completion (Actual)
January 10, 2007
Study Completion (Actual)
January 10, 2007
Study Registration Dates
First Submitted
June 29, 2006
First Submitted That Met QC Criteria
June 29, 2006
First Posted (Estimate)
July 4, 2006
Study Record Updates
Last Update Posted (Actual)
September 14, 2017
Last Update Submitted That Met QC Criteria
September 12, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Salmeterol Xinafoate
Other Study ID Numbers
- B2C106093
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD 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.
Study Data/Documents
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Statistical Analysis Plan
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Clinical Study Report
Information identifier: B2C106093Information comments: For additional information about this study please refer to the GSK Clinical Study Register
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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