Pediatric Asthma Study Using Stepwise Treatment With Two Food And Drug Administration Approved Asthma Medications
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158834
First received: September 8, 2005
Last updated: October 9, 2008
Last verified: October 2008
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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
- Salmeterol/Fluticasone propionate combination product
- Fluticasone propionate
Other Names:
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
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 Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013