Clinical trial NCT00158834: Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
Official title: Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (Seretide®) and/or Fluticasone Propionate (Flixotide®) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only (Children Asthma Therapy Optimal)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Children
Asthma
bronchial hyperresponsiveness
symptoms
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed to evaluate if, in children with asthma, a stepwise treatment (five levels varying from once daily fluticasone propionate 100mcg until twice daily a fixed combination of salmeterol and fluticasone propionate 50/500 mcg) based on symptom scores alone results in a sub-optimal treatment when compared to treatment based on cumulative symptom scores and bronchial hyperresponsiveness (PD20 methacholine).


Eligibility criteria: Inclusion criteria:

* Children with a documented history of asthma.
* Using inhaled steroids from 100 mcg up to 500 mcg twice daily for at least 1 month before study start.
* Must be able to perform reproducible lung function tests.
* Must have a positive RAST or skin prick test.
* During the treatment period, the patient has to be hyperreactive (defined as PD20 methacholine \< 150 mcg) and/or have a cumulative symptom score of 14 based on the daily record card filled in during the last 2 weeks of the run-in period.

Exclusion criteria:

* History of an acute upper or lower respiratory tract infection, middle ear, or sinus infection 4 weeks prior to visit 1.
* Admitted to hospital due to a respiratory disease 4 weeks prior to visit 1.
* Received oral corticosteroids within 4 weeks prior to visit 1.
* Existence of any disorder that affects growth.
* Clinical or laboratory evidence of a serious systemic disease, or suspected hypersensitivity to corticosteroids, lactose or short/long acting B2-agonists.

Primary outcomes:
measure: Asthma symptom free days during the last 12 weeks of the treatment period.
Secondary outcomes:
measure: Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: GSK Investigational Site
city: Almere
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
country: Netherlands
facility: GSK Investigational Site
city: Amsterdam
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: Groningen
country: Netherlands
facility: GSK Investigational Site
city: Hilversum
country: Netherlands
facility: GSK Investigational Site
city: Leiden
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Rotterdam
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, MD
role: STUDY_DIRECTOR
References: