Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

Asthma Clinical Trial

— STICS  

Official title:

Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066129
• Other study ID #: AsthmaNet 008
• Status: Completed
• Phase: Phase 3
• Start date: July 2014
• Est. completion date: April 21, 2017

Study information

• Verified date: June 2018
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: April 21, 2017
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 11 Years

Eligibility

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 + long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS] with a childhood Asthma Control Test (c-ACT) score of >19, no more than 2 prednisone treated exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1 second (FEV1) = 80% predicted and willing to step down therapy OR controller naïve and qualifying for step 2 controller therapy [asthma symptoms or short acting beta agonist (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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone 44 mcg
Fluticasone is an inhaled corticosteroid
• Fluticasone 220 mcg
Fluticasone is an inhaled corticosteroid

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	Children's Hospital Boston	Boston	Massachusetts
United States	Ann and Robert H. Lurie Children's Hospital	Chicago	Illinois
United States	Rush University Medical Center/Stroger Hospital	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	Rainbow Babies and Children's Hospital, Case Western Reserve University	Cleveland	Ohio
United States	National Jewish Health	Denver	Colorado
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	University of Wisconsin	Madison	Wisconsin
United States	Children's Hospital & Research Center Oakland	Oakland	California
United States	Nemours Children's Clinic	Orlando	Florida
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	Washington University	Saint Louis	Missouri
United States	UCSF Benioff Children's Hospital	San Francisco	California
United States	University of Arizona College of Medicine	Tucson	Arizona
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Exacerbations	The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.	end of 48 week treatment period
Secondary	Yellow Zone Asthma Symptoms	Study participants completed a daily symptom diary. They scored the following diary elements on a scale from 0-3 (none-severe): Cough, Wheeze, Trouble Breathing, Interference With Activities. A combined score was calculated as the sum of the 4 elements and ranged from 0 to 12. The study intervention was based on yellow-zones as noted in the Study Description. This outcome was based on diary data including 21 days, beginning 7 days prior to the onset of the yellow-zone intervention and ending 14 days after the onset of the intervention. The total symptom burden outcome was defined as the sum of the combined score on each diary day and ranged from 0 to 252 (max combined score of 12 per day multiplied by 21 days). A score of zero would indicate no symptoms over the entire 21 days. A score of 252 would indicate severe cough, wheeze, shortness of breath, and interference with activities on all of the 21 days.	end of 48 week treatment period
Secondary	Yellow Zone Albuterol Use	Use of albuterol rescue medication during 7-day yellow zone episodes.	end of 48 week treatment period
Secondary	Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma	Rate of emergency department (ED) or urgent care visits for asthma during the 48 week treatment period.	end of 48 week treatment period
Secondary	Number of Participants Hospitalized for Asthma	Number of participants hospitalized for asthma during the 48 week treatment period.	end of 48 week treatment period

External Links

•   AsthmaNet