Last updated: 11/04/2018 11:06:59
Treatment Of Symptomatic Asthma In Children
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A multicentre, randomised, double-blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100 mcg with Fluticasone propionate (Flixotide® ) 200 mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma
Trial description: This study is being conducted to investigate whether in childhood salmeterol/ fluticasone propionate 50/100 bd delivered via the Diskus® inhaler and fluticasone propionate 200 mcg bd delivered via the Diskus® inhaler are non- inferior in terms of symptom control. Additionally we aim to show that salmeterol/ fluticasone propionate 50/100 bd is at least as good in terms of lung function improvement and bronchial hyperreactivity and enables a steroid-sparing management of asthma in children.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage of symptom-free days during the last 10 weeks of the treatment period
Timeframe: Last 10 weeks of the treatment period (Weeks 16-26)
Secondary outcomes:
Percentage of symptom-free days during the entire treatment period
Timeframe: Baseline to Week 26
Mean change from Baseline in percentage predicted forced expiratory volume in one second (FEV1) at Week 26
Timeframe: Baseline and Week 26
Mean change from Baseline in forced vital capacity (FVC) at Week 26
Timeframe: Baseline and Week 26
Mean change from Baseline in midexpiratory flow (MEF 50) at Week 26
Timeframe: Baseline and Week 26
Geometric means of nitric oxide (NO) at week 26
Timeframe: Baseline and Week 26
Percent change from baseline in RINT measurements at Week 26
Timeframe: Baseline and Week 26
Number of asthma exacerbations per treatment group at Week 26
Timeframe: Week 26
Mean change from baseline in provocation dose (PD20) causing a 20% fall in FEV1 at Week 26
Timeframe: Baseline and Week 26
Bronchial hyperresponsiveness with PD20 AMP in selected centres
Timeframe: 26 weeks
Daily FEV1 and PEF via the electronic peak flow/FEV1 meter (PIKO-1)
Timeframe: 26 weeks
Frequency of asthma exacerbations (discriminated on severity)
Timeframe: 26 weeks
Cumulative number of symptom-free weeks until the end of treatment
Timeframe: 26 weeks
Weekly percentage of participants with ‘good controlled weeks’ and ‘maximal controlled weeks’
Timeframe: 26 weeks
Time to asthma control, defined as the time to first ‘good controlled week’ or ‘maximum controlled week'
Timeframe: 26 weeks
Interventions:
Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
Drug: fluticasone propionate 2 x 100 mcg
Enrollment:
176
Observational study model:
Not applicable
Primary completion date:
2008-15-10
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
June 2005 to October 2008
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
6 - 12 years
Accepts healthy volunteers
No
- Male or female subjects aged 6-12 years (inclusive)
- A female is eligible to enter and participate in the study if she is:
- Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
- Subjects who had an acute upper respiratory tract infection within 2 weeks or a lower respiratory tract infection within 4 weeks prior to visit 1
Inclusion and exclusion criteria
Inclusion criteria:
- A female is eligible to enter and participate in the study if she is: of non-child-bearing potential; OR of child-bearing potential, but not lactating and pregnant. She declares that it is not probable that she will become pregnant during the study (a pregnancy test can be performed at the investigators discretion)
- Subjects with a documented history of asthma for at least 6 months
- Subjects with a documented history of BHR within 12 months prior to inclusion or BHR on visit 1 (PD20 methacholine < 150 mcg or an equivalence for histamine)
- Subjects who have received BDP, budesonide up to 100-200 mcg bd or fluticasone propionate at a dose of up to 125 mcg bd for at least 4 weeks before the start of the run-in period.
- Subjects who are able to use a electronic peakflow /FEV1 meter (PIKO-1)
- Subjects who have a normal length SD score between -2SD and +2SD
- 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 and their guardians, who have given written informed consent to participate in the study
- Subjects or their parent/ guardian who are able to understand and complete a DRC. The DRC may be completed by a parent/guardian if the subject is unable to do this him/ herself
- Subjects able to use Ventolin on an 'as required for symptoms' basis
Male or female subjects aged 6-12 years (inclusive)
Exclusion criteria:
- Subjects who had an acute upper respiratory tract infection within 2 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 with a disorder that affects growth (e.g. Turner's syndrome)
- Subjects who have received any investigational drugs within 4 weeks of visit 1
- Subjects with a known or suspected hypersensitivity to inhaled steroids, β2-agonists or lactose
- Subjects who use any medication that significantly inhibit 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 trial
Subjects who have been hospitalised for their asthma within 4 weeks of visit 1
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-15-10
Actual study completion date
2008-15-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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