Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
Information source: GlaxoSmithKline
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Salmeterol/Fluticasone propionate combination product (Drug); Fluticasone propionate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s):
GSK Clinical Trials, MD, Study Director, Affiliation: GlaxoSmithKline
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).
Clinical Details
Official title: Comparison of Stepwise Treatment of Asthmatic Children With Salmeterol/Fluticasone Propionate Combination Product (SeretideŽ) and/or Fluticasone Propionate (FlixotideŽ) Based on PD20 Methacholine and Symptoms or Based on Symptoms Only (Children Asthma Therapy Optimal)
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Asthma symptom free days during the last 12 weeks of the treatment period.
Secondary outcome: Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.
Eligibility
Minimum age: 6 Years.
Maximum age: 16 Years.
Gender(s): Both.
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.
Locations and Contacts
GSK Clinical Trials Call Center, AMSTERDAM 1081HV, Netherlands
GSK Clinical Trials Call Center, AMSTERDAM ZUIDOOST 1105AZ, Netherlands
GSK Clinical Trials Call Center, HILVERSUM 1213VX, Netherlands
GSK Clinical Trials Call Center, ALMERE 1315RA, Netherlands
GSK Clinical Trials Call Center, ALKMAAR 1815JD, Netherlands
GSK Clinical Trials Call Center, LEIDEN 2333ZA, Netherlands
GSK Clinical Trials Call Center, SITTARD 6131BK, Netherlands
GSK Clinical Trials Call Center, MAASTRICHT 6229HX, Netherlands
GSK Clinical Trials Call Center, ROTTERDAM 3015GJ, Netherlands
GSK Clinical Trials Call Center, BREDA 4818CK, Netherlands
GSK Clinical Trials Call Center, ZWOLLE 8011JW, Netherlands
GSK Clinical Trials Call Center, GRONINGEN 9713GZ, Netherlands
GSK Clinical Trials Call Center, VELDHOVEN 5504DB, Netherlands
GSK Clinical Trials Call Center, S GRAVENHAGE 2566ER, Netherlands
GSK Clinical Trials Call Center, UTRECHT 3584EA, Netherlands
Additional Information
Starting date: November 1999
Last updated: May 17, 2006
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