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

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Asthma

Treatments

Drug: Salmeterol/Fluticasone propionate combination product

Drug: Fluticasone propionate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00158834

SAS30018

SER9702/CATO

Details and patient eligibility

About

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).

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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.