A multi-centre, randomised, double blind, stratified, and parallel group study to evaluate whether a treatment strategy based on aiming for ‘Total control’ results in better airway hyper-responsiveness than a treatment strategy based on maintaining the treatment level at which ‘Well-controlled’ asthma was achieved.
- Conditions
- Asthma
- Registration Number
- EUCTR2005-002950-23-DE
- Lead Sponsor
- GlaxoSmithKline Research & Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 185
A subject will be eligible for inclusion in the run-in period only if all of the following inclusion criteria apply:
•Male or female subjects > 18 years
•Subjects with a documented history of asthma for a period of at least 6 months
•Subjects with a PC20 methacholine < 8 mg/ml at Visit 1
•Subjects with a FEV1 % predicted > 70% at Visit 1
•Subjects who have received fluticasone proprionate at a dose of 100 mcg bd to 250 mcg bd or equivalent with or without a long acting beta2-agonist for at least 4 weeks before the start of the run-in period, at a constant dose.
•Subjects who are able to use a Mini Wright peakflow meter
•Subjects who are able to use a DISKUS™ inhaler
•Subjects who are able to perform reproducible lung function tests at Visit 1 (variation FEV1 < 5% between the two best measurements)
•Subjects who are able to comply with therapy
•Subjects who are able to understand and complete an electronic DRC.
•Subjects able to use VENTOLIN™ on an ‘as required for symptoms’ basis
•Subjects who have given written informed consent to participate in the study prior to study participation
•A female is eligible to enter and participate in the study if she is:
a.of non-child-bearing potential;
OR
b.of child-bearing potential but has a negative urinary pregnancy test at screening (and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study.
A subject will be eligible for inclusion in this study only if all of the following inclusion criteria for the treatment period are met at randomization:
•Subjects with a control status of ‘Well-controlled’ asthma excluding subjects with a control status of ‘Total control’ during the last 8 weeks of the run-in period
•Subject with a FEV1 % predicted > 70%
•Subjects must have recorded data on > 80% of daily entries into their eDRC throughout the run-in period
•If subject is of child bearing potential, a negative pregnancy urine test must be performed.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
A subject will not be eligible for inclusion in this study if any of the following criteria are met:
•Subjects who have been hospitalised for their asthma within 4 weeks of Visit 1
•Subjects who had an acute upper respiratory tract infection within 4 weeks or a lower respiratory tract infection within 4 weeks prior to Visit 1
•Subjects who received oral, parental or depot corticosteroids within 4 weeks prior to Visit 1
•Subjects who have a known respiratory disorder other than asthma and/or systemic/thoracic abnormalities which influence normal lung function
•Subjects who have received any investigational drugs within 4 weeks of Visit 1
•Subjects with a known or suspected hypersensitivity to inhaled steroids, ß2-agonists or lactose
•Subjects who use any medication that significantly inhibits the cytochrome P450 subfamily enzyme CYP3A4, including ritonavir and ketoconazole
•Subjects who concurrently participate in another clinical study
•Subjects who have previously been randomised in this study
•Smoking history: Subjects who have more than 5 pack years
•Subjects who currently smoke
Subjects will be excluded from participating in the treatment period of the study if the following, in addition to the exclusion criteria for entry into the run-period, occurred during the run-in period:
•Any change in their run-in asthma medication
•Non-compliance with the completion of the eDRC
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method