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

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)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00158834

Enrollment

200

Registered

2005-09-12

Start date

1999-11-30

Completion date

Unknown

Last updated

2008-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Children, Asthma, bronchial hyperresponsiveness, symptoms

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).

Interventions

DRUGSalmeterol/Fluticasone propionate combination product

DRUGFluticasone propionate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

6 Years to 16 Years

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.

Design outcomes

Primary

Measure	Time frame
Asthma symptom free days during the last 12 weeks of the treatment period.	—

Secondary

Measure	Time frame
Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026