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Trial record 89 of 318 for:    FLUTICASONE AND SALMETEROL

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158834
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 13, 2008
Information provided by:

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 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 or disease Intervention/treatment Phase
Asthma Drug: Salmeterol/Fluticasone propionate combination product Drug: Fluticasone propionate Phase 3

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Study Type : Interventional  (Clinical Trial)
Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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)
Study Start Date : November 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Intervention Details:
  • Drug: Salmeterol/Fluticasone propionate combination product
  • Drug: Fluticasone propionate
    Other Name: Salmeterol/Fluticasone propionate combination product

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158834

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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
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Study Director: GSK Clinical Trials, MD GlaxoSmithKline

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Responsible Party: Study Director, GSK Identifier: NCT00158834     History of Changes
Other Study ID Numbers: SAS30018
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 13, 2008
Last Verified: October 2008
Keywords provided by GlaxoSmithKline:
bronchial hyperresponsiveness
Additional relevant MeSH terms:
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Salmeterol Xinafoate
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action