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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00347139
Registration number
NCT00347139
Ethics application status
Date submitted
29/06/2006
Date registered
4/07/2006
Date last updated
14/09/2017
Titles & IDs
Public title
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
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Scientific 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
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Secondary ID [1]
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B2C106093
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GW642444 (25, 100 & 400 mcg/day)
Treatment: Drugs - Salmeterol 50mcg
Experimental: GW642444 -
Active Comparator: Salmeterol -
Treatment: Drugs: GW642444 (25, 100 & 400 mcg/day)
25, 100 and 400mcg/dose
Treatment: Drugs: Salmeterol 50mcg
Salmeterol 50mcg
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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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Timepoint [1]
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From Baseline (pre-dose on Day 1) and up to 14 days
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Secondary outcome [1]
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Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14
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Assessment method [1]
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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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Timepoint [1]
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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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Secondary outcome [2]
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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
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Assessment method [2]
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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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Timepoint [2]
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Baseline (pre-dose on Day 1) and up to 15 days
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Secondary outcome [3]
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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
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Assessment method [3]
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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. 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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Timepoint [3]
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Baseline (pre-dose on Day 1) and up to 14 days
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Secondary outcome [4]
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Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15
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Assessment method [4]
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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 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.
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Timepoint [4]
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Baseline (pre-dose on Day 1), Day 2, and Day 15
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Secondary outcome [5]
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Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days
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Assessment method [5]
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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. 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.
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Timepoint [5]
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Baseline (pre-dose on Day 1) and up to Day 14
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Secondary outcome [6]
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Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14
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Assessment method [6]
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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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Timepoint [6]
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Day 1, 7, and 14
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Secondary outcome [7]
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Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14
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Assessment method [7]
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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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Timepoint [7]
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Day 1, 7, and 14
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Eligibility
Key inclusion 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.
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
23/05/2006
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
10/01/2007
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Sample size
Target
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Accrual to date
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Final
55
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Hessen
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Country [2]
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Germany
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State/province [2]
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Schleswig-Holstein
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Country [3]
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New Zealand
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State/province [3]
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Wellington
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Country [4]
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Russian Federation
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State/province [4]
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Moscow
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Country [5]
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Sweden
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State/province [5]
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Göteborg
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Country [6]
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Sweden
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State/province [6]
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Stockholm
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Country [7]
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United Kingdom
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State/province [7]
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London
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00347139
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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GSK Clinical Trials
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Address
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GlaxoSmithKline
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00347139
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