Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Milton S. Hershey Medical Center
Sponsor:
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT02066129
First received: February 17, 2014
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: Fluticasone 44 mcg
Drug: Fluticasone 220 mcg
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

Primary Outcome Measures:
  • Asthma exacerbations [ Time Frame: end of 48 week treatment period ] [ Designated as safety issue: No ]
    The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.


Estimated Enrollment: 250
Study Start Date: July 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Fluticasone 44 mcg
Fluticasone 44 mcg 2 puffs twice daily for 7 days intiated at the onset of "yellow zone" symptoms.
Drug: Fluticasone 44 mcg
Fluticasone is an inhaled corticosteroid
Other Name: Flovent® 44 mcg
Active Comparator: Fluticasone 220 mcg
Fluticasone 220 mcg 2 puffs twice daily for 7 days intiated at the onset of "yellow zone" symptoms.
Drug: Fluticasone 220 mcg
Fluticasone is an inhaled corticosteroid
Other Name: Flovent® 220 mcg

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.

  Eligibility

Ages Eligible for Study:   5 Years to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02066129

Contacts
Contact: David Mauger, PhD dtm5@psu.edu

Locations
United States, Arizona
University of Arizona College of Medicine Recruiting
Tucson, Arizona, United States, 85724
United States, California
Children's Hospital & Research Center Oakland Recruiting
Oakland, California, United States, 94609
UCSF Benioff Children's Hospital Recruiting
San Francisco, California, United States, 94143
United States, Colorado
National Jewish Health Recruiting
Denver, Colorado, United States, 80206
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Nemours Children's Clinic Recruiting
Orlando, Florida, United States, 32827
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
United States, Illinois
Ann and Robert H. Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60614
Rush University Medical Center/Stroger Hospital Recruiting
Chicago, Illinois, United States, 60612
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
United States, Massachusetts
Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
United States, Missouri
St. Louis Children's Hospital Recruiting
St. Louis, Missouri, United States, 63110
Washington University Recruiting
St. Louis, Missouri, United States, 63110
United States, North Carolina
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Rainbow Babies and Children's Hospital, Case Western Reserve University Recruiting
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53972
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Study Chair: William Busse, MD University of Wisconsin, Madison
  More Information

Additional Information:
No publications provided

Responsible Party: dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02066129     History of Changes
Other Study ID Numbers: AsthmaNet 008
Study First Received: February 17, 2014
Last Updated: April 6, 2015
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by Milton S. Hershey Medical Center:
Asthma
Fluticasone

Additional relevant MeSH terms:
Fluticasone
Anti-Allergic Agents
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Dermatologic Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 30, 2015