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

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00158834

Collaborator

(none)

200

Enrollment

Locations

12.5

Patients Per Site

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Salmeterol/Fluticasone propionate combination product Drug: Fluticasone propionate	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double

Primary Purpose:

Treatment

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)

Study Start Date :

Nov 1, 1999

Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 16 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	GSK Investigational Site	Alkmaar	Netherlands	1815 JD
2	GSK Investigational Site	Almere	Netherlands	1315 RA
3	GSK Investigational Site	Amsterdam	Netherlands	1081 HV
4	GSK Investigational Site	Amsterdam	Netherlands	1105 AZ
5	GSK Investigational Site	Breda	Netherlands	4818 CK
6	GSK Investigational Site	Den Haag	Netherlands	2566 MJ
7	GSK Investigational Site	Eindhoven	Netherlands	5623 EJ
8	GSK Investigational Site	Groningen	Netherlands	9713 GZ
9	GSK Investigational Site	Hilversum	Netherlands	1213 VX
10	GSK Investigational Site	Leiden	Netherlands	2333 ZA
11	GSK Investigational Site	Maastricht	Netherlands	6229 HX
12	GSK Investigational Site	Rotterdam	Netherlands	3015 GD
13	GSK Investigational Site	Sittard	Netherlands	6131 BK
14	GSK Investigational Site	Utrecht	Netherlands	3584 EA
15	GSK Investigational Site	Veldhoven	Netherlands	5504 DB
16	GSK Investigational Site	Zwolle	Netherlands	8011 JW