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Status:

COMPLETED

Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications

Lead Sponsor:

GlaxoSmithKline

Conditions:

Asthma

Eligibility:

All Genders

6-16 years

Phase:

PHASE3

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 salmet...

Eligibility Criteria

Inclusion

  • 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.

Exclusion

    Key Trial Info

    Start Date :

    November 1 1999

    Trial Type :

    INTERVENTIONAL

    End Date :

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT00158834

    Start Date

    November 1 1999

    Last Update

    October 13 2008

    Active Locations (16)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 4 (16 locations)

    1

    GSK Investigational Site

    Alkmaar, Netherlands, 1815 JD

    2

    GSK Investigational Site

    Almere Stad, Netherlands, 1315 RA

    3

    GSK Investigational Site

    Amsterdam, Netherlands, 1081 HV

    4

    GSK Investigational Site

    Amsterdam, Netherlands, 1105 AZ