Phase 4
N=257
Treatment Of Symptomatic Asthma In Children
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00197106 ↗Enrolled (actual)
257
Serious AEs
3.2%
Results posted
Dec 2009
Primary outcome: Primary: Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period — 50.45; 49.75 percentage of days — p=0.63
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg (Drug); fluticasone propionate 2 x 100 mcg (Drug)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period |
50.45; 49.75 | 0.63 |
| SECONDARY Percentage of Symptom-free Days During the Entire Treatment Period |
22.78; 23.06; 31.58; 31.50; 44.60; 45.24 | — |
| SECONDARY Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26 |
102.5; 103.0 | — |
| SECONDARY Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26 |
2.28; 2.28 | — |
| SECONDARY Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26 |
2.28; 2.19 | — |
| SECONDARY Geometric Means of Nitric Oxide (NO) at Week 26 |
8.6; 10.0 | — |
| SECONDARY Percent Change From Baseline in RINT Measurements at Week 26 |
-9.1; -9.9 | — |
| SECONDARY Number of Asthma Exacerbations Per Treatment Group at Week 26 |
10; 7 | — |
| SECONDARY Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26 |
2.7; 1.5 | — |
| SECONDARY Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres |
— | — |
| SECONDARY Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1) |
— | — |
| SECONDARY Frequency of Asthma Exacerbations (Discriminated on Severity) |
— | — |
| SECONDARY Cumulative Number of Symptom-free Weeks Until the End of Treatment |
— | — |
| SECONDARY Weekly Percentage of Participants With 'Good Controlled Weeks' and 'Maximal Controlled Weeks' |
— | — |
| SECONDARY Time to Asthma Control, Defined as the Time to First 'Good Controlled Week' or 'Maximum Controlled Week' |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00197106). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.