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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: Fluticasone; Salmeterol Xinafoate; Xhance

Criteria

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.