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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158834
First received: September 8, 2005
Last updated: October 9, 2008
Last verified: October 2008
  Purpose

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).


Condition Intervention Phase
Asthma
Drug: Salmeterol/Fluticasone propionate combination product
Drug: Fluticasone propionate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official 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)

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Asthma symptom free days during the last 12 weeks of the treatment period.

Secondary Outcome Measures:
  • Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.

Estimated Enrollment: 200
Study Start Date: November 1999
Intervention Details:
    Drug: Salmeterol/Fluticasone propionate combination product Drug: Fluticasone propionate
    Other Names:
    • Salmeterol/Fluticasone propionate combination product
    • Fluticasone propionate
  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00158834

Locations
Netherlands
GSK Investigational Site
Alkmaar, Netherlands, 1815 JD
GSK Investigational Site
Almere, Netherlands, 1315 RA
GSK Investigational Site
Amsterdam, Netherlands, 1081 HV
GSK Investigational Site
Amsterdam, Netherlands, 1105 AZ
GSK Investigational Site
Breda, Netherlands, 4818 CK
GSK Investigational Site
Den Haag, Netherlands, 2566 MJ
GSK Investigational Site
Eindhoven, Netherlands, 5623 EJ
GSK Investigational Site
Groningen, Netherlands, 9713 GZ
GSK Investigational Site
Hilversum, Netherlands, 1213 VX
GSK Investigational Site
Leiden, Netherlands, 2333 ZA
GSK Investigational Site
Maastricht, Netherlands, 6229 HX
GSK Investigational Site
Rotterdam, Netherlands, 3015 GD
GSK Investigational Site
Sittard, Netherlands, 6131 BK
GSK Investigational Site
Utrecht, Netherlands, 3584 EA
GSK Investigational Site
Veldhoven, Netherlands, 5504 DB
GSK Investigational Site
Zwolle, Netherlands, 8011 JW
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00158834     History of Changes
Other Study ID Numbers: SAS30018, SER9702/CATO
Study First Received: September 8, 2005
Last Updated: October 9, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by GlaxoSmithKline:
Children
Asthma
bronchial hyperresponsiveness
symptoms

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Fluticasone
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on August 28, 2014