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

Asthma Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158834
• Other study ID #: SAS30018
• Secondary ID: SER9702/CATO
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: October 9, 2008
• Start date: November 1999

Study information

• Verified date: October 2008
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Salmeterol/Fluticasone propionate combination product

• Fluticasone propionate

Locations

Country	Name	City	State
Netherlands	GSK Investigational Site	Alkmaar
Netherlands	GSK Investigational Site	Almere
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Amsterdam
Netherlands	GSK Investigational Site	Breda
Netherlands	GSK Investigational Site	Den Haag
Netherlands	GSK Investigational Site	Eindhoven
Netherlands	GSK Investigational Site	Groningen
Netherlands	GSK Investigational Site	Hilversum
Netherlands	GSK Investigational Site	Leiden
Netherlands	GSK Investigational Site	Maastricht
Netherlands	GSK Investigational Site	Rotterdam
Netherlands	GSK Investigational Site	Sittard
Netherlands	GSK Investigational Site	Utrecht
Netherlands	GSK Investigational Site	Veldhoven
Netherlands	GSK Investigational Site	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma symptom free days during the last 12 weeks of the treatment period.
Secondary	Bronchial hyperresponsiveness, determined by PD20 methacholine at the end of the study.