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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

Page last updated: August 23, 2015

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