Overview

This trial is active, not recruiting.

Condition asthma
Treatments fluticasone 44 mcg, fluticasone 220 mcg
Phase phase 3
Sponsor Milton S. Hershey Medical Center
Start date July 2014
End date July 2017
Trial size 250 participants
Trial identifier NCT02066129, AsthmaNet 008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Fluticasone 44 mcg 2 puffs twice daily for 7 days intiated at the onset of "yellow zone" symptoms.
fluticasone 44 mcg Flovent® 44 mcg
Fluticasone is an inhaled corticosteroid
(Active Comparator)
Fluticasone 220 mcg 2 puffs twice daily for 7 days intiated at the onset of "yellow zone" symptoms.
fluticasone 220 mcg Flovent® 220 mcg
Fluticasone is an inhaled corticosteroid

Primary Outcomes

Measure
Asthma exacerbations
time frame: end of 48 week treatment period

Secondary Outcomes

Measure
Yellow zone asthma symptoms
time frame: end of 48 week treatment period
Yellow zone albuterol use
time frame: end of 48 week treatment period
Unscheduled emergency department (ED) or urgent care visits for asthma
time frame: end of 48 week treatment period
Hospitalizations for asthma
time frame: end of 48 week treatment period

Eligibility Criteria

Male or female participants from 5 years up to 11 years old.

Inclusion Criteria: - Physician-diagnosed asthma - At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in the past 12 months - Able to perform reproducible spirometry - Current treatment with step 2 controller therapy [low-dose ICS, leukotriene receptor antagonist (LTRA)] OR current treatment with step 3 controller therapy [low-dose ICS + LABA, low-dose ICS + LTRA, or medium dose ICS] with a c-ACT score of >19, no more than 2 prednisone treated exacerbations in the past 6 months, prebronchodilator FEV1 ≥ 80% predicted and willing to step down therapy OR controller naïve and qualifying for step 2 controller therapy [asthma symptoms or SABA use > 2 days per week or night-time awakenings due to asthma > 2 nights per month] - Prebronchodilator FEV1 ≥ 60% predicted - Ability and willingness to provide informed assent - For females of childbearing potential: not pregnant, non-lactating, and agree to practice an adequate birth control method. - History of clinical varicella or varicella vaccine Exclusion Criteria: - Systemic (oral or injectable) corticosteroids within previous 2-week period - Current or recent (previous 2-weeks) use of medications known to significantly interact with corticosteroid disposition, including but not limited to carbamazepine, erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole - Presence of chronic or active lung disease other than asthma - Significant medical illness other than asthma, including thyroid disease, diabetes mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical problems that could require oral corticosteroids during the study - A history of cataracts, glaucoma, or any other medical disorder associated with an adverse effect to corticosteroids - History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure - More than 5 prednisone treated exacerbations in the past 12 months - More than 1 hospitalizations lasting >24 hours for asthma in the past 12 months - History of adverse reactions to ICS preparations or any of their ingredients - Receiving hyposensitization therapy other than an established maintenance regimen (On maintenance regimen for ≥ 3 months) - History of premature birth before 35 weeks gestation

Additional Information

Official title Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Milton S. Hershey Medical Center.