Clinical trial NCT00197106: Treatment Of Symptomatic Asthma In Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Keywords: salmeterol/fluticasone combination
Asthma
bronchial hyperresponsiveness
Children
symptom control
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 176
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: A multicentre, randomised, double blind, parallel group study to compare the efficacy and safety of Salmeterol/Fluticasone propionate combination product (Seretide®) 50/100mcg with Fluticasone propionate (Flixotide®) 200mcg, both delivered twice daily via the DISKUS inhaler, in the treatment of children aged 6-12 years with symptomatic asthma.

Eligibility criteria: Inclusion criteria:

* Male or female subjects aged 6-12 years (inclusive)
* 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

Exclusion criteria:

* 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
* 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

Primary outcomes:
measure: 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:
measure: Percentage of Symptom-free Days During the Entire Treatment Period
timeFrame: Baseline to Week 26
measure: Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26
timeFrame: Baseline and Week 26
measure: Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26
timeFrame: Baseline and Week 26
measure: Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26
timeFrame: Baseline and Week 26
measure: Geometric Means of Nitric Oxide (NO) at Week 26
timeFrame: Baseline and Week 26
measure: Percent Change From Baseline in RINT Measurements at Week 26
timeFrame: Baseline and Week 26
measure: Number of Asthma Exacerbations Per Treatment Group at Week 26
timeFrame: Week 26
measure: Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26
timeFrame: Baseline and Week 26
measure: Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres
timeFrame: 26 weeks
measure: Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)
timeFrame: 26 weeks
measure: Frequency of Asthma Exacerbations (Discriminated on Severity)
timeFrame: 26 weeks
measure: Cumulative Number of Symptom-free Weeks Until the End of Treatment
timeFrame: 26 weeks
measure: Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks'
timeFrame: 26 weeks
measure: Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week'
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Almere
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Arnhem
country: Netherlands
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Den Haag
country: Netherlands
facility: GSK Investigational Site
city: Eindhoven
country: Netherlands
facility: GSK Investigational Site
city: Enschede
country: Netherlands
facility: GSK Investigational Site
city: Gouda
country: Netherlands
facility: GSK Investigational Site
city: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Helmond
country: Netherlands
facility: GSK Investigational Site
city: Hoorn
country: Netherlands
facility: GSK Investigational Site
city: Leeuwarden
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Sittard
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Veldhoven
country: Netherlands
facility: GSK Investigational Site
city: Zwolle
country: Netherlands
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Vaessen-Verberne AA, van den Berg NJ, van Nierop JC, Brackel HJ, Gerrits GP, Hop WC, Duiverman EJ; COMBO Study Group. Combination therapy salmeterol/fluticasone versus doubling dose of fluticasone in children with asthma. Am J Respir Crit Care Med. 2010 Nov 15;182(10):1221-7. doi: 10.1164/rccm.201002-0193OC. Epub 2010 Jul 9.