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

This study has been completed.

First Received: September 8, 2005 Last Updated: October 9, 2008 History of Changes

Sponsor:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00158834

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: Asthma

Drug Information available for: Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate

U.S. FDA Resources

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

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
UTRECHT, Netherlands, 3584 EA
GSK Investigational Site
HILVERSUM, Netherlands, 1213 VX
GSK Investigational Site
EINDHOVEN, Netherlands, 5623 EJ
GSK Investigational Site
AMSTERDAM, Netherlands, 1105 AZ
GSK Investigational Site
AMSTERDAM, Netherlands, 1081 HV
GSK Investigational Site
MAASTRICHT, Netherlands, 6229 HX
GSK Investigational Site
SITTARD, Netherlands, 6131 BK
GSK Investigational Site
LEIDEN, Netherlands, 2333 ZA
GSK Investigational Site
ALMERE, Netherlands, 1315 RA
GSK Investigational Site
ZWOLLE, Netherlands, 8011 JW
GSK Investigational Site
HILVERSUM, Netherlands, 1213 VX
GSK Investigational Site
VELDHOVEN, Netherlands, 5504 DB
GSK Investigational Site
DEN HAAG, Netherlands, 2566 MJ
GSK Investigational Site
ROTTERDAM, Netherlands, 3015 GD
GSK Investigational Site
ALKMAAR, Netherlands, 1815 JD
GSK Investigational Site
GRONINGEN, Netherlands, 9713 GZ
GSK Investigational Site
BREDA, Netherlands, 4818 CK
GSK Investigational Site
AMSTERDAM, Netherlands, 1081 HV

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials, MD

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	SAS30018, SER9702/CATO
Study First Received:	September 8, 2005
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00158834 History of Changes
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:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses
Fluticasone
Dermatologic Agents

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010