Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS)
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| ClinicalTrials.gov Identifier: NCT02066129 |
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Recruitment Status :
Completed
First Posted : February 19, 2014
Results First Posted : July 11, 2018
Last Update Posted : July 11, 2018
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Sponsor:
Milton S. Hershey Medical Center
Information provided by (Responsible Party):
dave mauger, Milton S. Hershey Medical Center
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Asthma | Drug: Fluticasone 44 mcg Drug: Fluticasone 220 mcg | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 254 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations |
| Study Start Date : | July 2014 |
| Actual Primary Completion Date : | April 21, 2017 |
| Actual Study Completion Date : | April 21, 2017 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Fluticasone 44 mcg
Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
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Drug: Fluticasone 44 mcg
Fluticasone is an inhaled corticosteroid
Other Name: Flovent® 44 mcg |
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Active Comparator: Fluticasone 220 mcg
Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms.
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Drug: Fluticasone 220 mcg
Fluticasone is an inhaled corticosteroid
Other Name: Flovent® 220 mcg |
Primary Outcome Measures :
- Asthma Exacerbations [ Time Frame: end of 48 week treatment period ]The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.
Secondary Outcome Measures :
- Yellow Zone Asthma Symptoms [ Time Frame: end of 48 week treatment period ]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.
- Yellow Zone Albuterol Use [ Time Frame: end of 48 week treatment period ]Use of albuterol rescue medication during 7-day yellow zone episodes.
- Unscheduled Emergency Department (ED) or Urgent Care Visits for Asthma [ Time Frame: end of 48 week treatment period ]Rate of emergency department (ED) or urgent care visits for asthma during the 48 week treatment period.
- Number of Participants Hospitalized for Asthma [ Time Frame: end of 48 week treatment period ]Number of participants hospitalized for asthma during the 48 week treatment period.
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| Ages Eligible for Study: | 5 Years to 11 Years (Child) |
| Sexes Eligible for Study: | All |
| 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 + 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02066129
Locations
Show 18 study locations
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
| Study Chair: | William Busse, MD | University of Wisconsin, Madison |
Study Documents (Full-Text)
Documents provided by dave mauger, Milton S. Hershey Medical Center:
Documents provided by dave mauger, Milton S. Hershey Medical Center:
Study Protocol and Statistical Analysis Plan [PDF] March 16, 2015
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | dave mauger, Principal Investigator, AsthmaNet Data Coordinating Center, Milton S. Hershey Medical Center |
| ClinicalTrials.gov Identifier: | NCT02066129 |
| Other Study ID Numbers: |
AsthmaNet 008 |
| First Posted: | February 19, 2014 Key Record Dates |
| Results First Posted: | July 11, 2018 |
| Last Update Posted: | July 11, 2018 |
| Last Verified: | June 2018 |
Keywords provided by dave mauger, Milton S. Hershey Medical Center:
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Asthma Fluticasone |
Additional relevant MeSH terms:
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Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone |
Xhance Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |