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OpenTrials
Completed

NCT Number: NCT00158834

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

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).

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Key information

Conditions

Asthma Bronchial Diseases Bronchial Hyperreactivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Alkmaar, Netherlands

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Salmeterol/Fluticasone propionate combination product

Drug

Fluticasone propionate

Drug

Other names: Salmeterol/Fluticasone propionate combination product

Primary outcomes

  1. Asthma symptom free days during the last 12 weeks of the treatment period.

Secondary outcomes

  1. Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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)

Important dates

Study start
1999
First posted
Sep 12, 2005
Registry last updated
Oct 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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