Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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 Investigational Site, Alkmaar 1815 JD, Netherlands
GSK Investigational Site, Almere 1315 RA, Netherlands
GSK Investigational Site, Amsterdam 1105 AZ, Netherlands
GSK Investigational Site, Amsterdam 1081 HV, Netherlands
GSK Investigational Site, Breda 4818 CK, Netherlands
GSK Investigational Site, Den Haag 2566 MJ, Netherlands
GSK Investigational Site, Eindhoven 5623 EJ, Netherlands
GSK Investigational Site, Groningen 9713 GZ, Netherlands
GSK Investigational Site, Hilversum 1213 VX, Netherlands
GSK Investigational Site, Leiden 2333 ZA, Netherlands
GSK Investigational Site, Maastricht 6229 HX, Netherlands
GSK Investigational Site, Rotterdam 3015 GD, Netherlands
GSK Investigational Site, Sittard 6131 BK, Netherlands
GSK Investigational Site, Utrecht 3584 EA, Netherlands
GSK Investigational Site, Veldhoven 5504 DB, Netherlands
GSK Investigational Site, Zwolle 8011 JW, Netherlands
Additional Information
Starting date: November 1999
Last updated: October 9, 2008
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