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Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
This study has been completed.
Study NCT00158834   Information provided by GlaxoSmithKline
First Received: September 8, 2005   Last Updated: October 9, 2008   History of Changes

September 8, 2005
October 9, 2008
November 1999
 
Asthma symptom free days during the last 12 weeks of the treatment period.
Asthma symptom free days during the last 12 weeks of the treatment period
Complete list of historical versions of study NCT00158834 on ClinicalTrials.gov Archive Site
Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.
Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study
 
Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
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)

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).

 
Phase III
Interventional
Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
Asthma
  • Drug: Salmeterol/Fluticasone propionate combination product
  • Drug: Fluticasone propionate
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
200
 
 

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.
Both
6 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00158834
Study Director, GSK
SAS30018, SER9702/CATO
GlaxoSmithKline
 
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
GlaxoSmithKline
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP