NCT02066129

Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 254 (actual)
• Sponsor: Milton S. Hershey Medical Center · Academic / Other
• Sex: All
• Age: 5 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to determine whether, in children receiving low-dose inhaled corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations reduces the rate of severe asthma exacerbations treated with oral corticosteroids.

Detailed description

The study design is a double-blind, parallel-group trial, including a total of 250 participants, ages 5-11 years, with a diagnosis of asthma and a history of at least 1 asthma exacerbation treated with oral corticosteroids in the prior year. All participants will be treated for 48 weeks with open-label fluticasone 44 mcg 2 puffs twice daily. During the 48-week treatment period, participants will receive randomized blinded therapy for 7 days each time they enter the "yellow zone" (at the onset of symptoms previously associated with upper respiratory illnesses and subsequent asthma exacerbations). Yellow zone therapy will be fluticasone 44 or 220 mcg 2 puffs twice daily.

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	Fluticasone 44 mcg	Fluticasone is an inhaled corticosteroid
DRUG	Fluticasone 220 mcg	Fluticasone is an inhaled corticosteroid

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-04-21
• Completion: 2017-04-21
• First posted: 2014-02-19
• Last updated: 2018-07-11
• Results posted: 2018-07-11

Locations

18 sites across 1 country: United States