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

NCT ID: NCT00158834

Last Updated: 2008-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Brief Summary

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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).

Detailed Description

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Conditions

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Asthma

Keywords

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Children Asthma bronchial hyperresponsiveness symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Salmeterol/Fluticasone propionate combination product

Intervention Type DRUG

Fluticasone propionate

Intervention Type DRUG

Other Intervention Names

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Salmeterol/Fluticasone propionate combination product

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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GSK

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Alkmaar, , Netherlands

Site Status

GSK Investigational Site

Almere Stad, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Amsterdam, , Netherlands

Site Status

GSK Investigational Site

Breda, , Netherlands

Site Status

GSK Investigational Site

Eindhoven, , Netherlands

Site Status

GSK Investigational Site

Groningen, , Netherlands

Site Status

GSK Investigational Site

Hilversum, , Netherlands

Site Status

GSK Investigational Site

Leiden, , Netherlands

Site Status

GSK Investigational Site

Maastricht, , Netherlands

Site Status

GSK Investigational Site

Rotterdam, , Netherlands

Site Status

GSK Investigational Site

Sittard, , Netherlands

Site Status

GSK Investigational Site

The Hague, , Netherlands

Site Status

GSK Investigational Site

Utrecht, , Netherlands

Site Status

GSK Investigational Site

Veldhoven, , Netherlands

Site Status

GSK Investigational Site

Zwolle, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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SER9702/CATO

Identifier Type: -

Identifier Source: secondary_id

SAS30018

Identifier Type: -

Identifier Source: org_study_id