AsthmaPhase 3STICSNCT02066129
Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
A Phase 3 study testing Fluticasone 44 mcg and Fluticasone 220 mcg in people with Asthma, run by Milton S. Hershey Medical Center at 18 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 5 to 11 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone 44 mcg and Fluticasone 220 mcg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- 18 sitesUnited States
- Study dates
- Jul 2014to 21 Apr 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory University
Atlanta, Georgia, 30322
Children's Hospital Boston
Boston, Massachusetts, 02115
Rush University Medical Center/Stroger Hospital
Chicago, Illinois, 60612
University of Illinois at Chicago
Chicago, Illinois, 60612
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, 60614
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, 44106
National Jewish Health
Denver, Colorado, 80206
Nemours Children's Clinic
Jacksonville, Florida, 32207
University of Wisconsin
Madison, Wisconsin, 53972
Children's Hospital & Research Center Oakland
Oakland, California, 94609
Nemours Children's Clinic
Orlando, Florida, 32827
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
UCSF Benioff Children's Hospital
San Francisco, California, 94143
St. Louis Children's Hospital
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
University of Arizona College of Medicine
Tucson, Arizona, 85724
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
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.
Read the 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
- Being tested
- Fluticasone 44 mcg, Fluticasone 220 mcg
- Keywords
- Asthma, Fluticasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone 44 mcgDrug
Also called Flovent® 44 mcg
Fluticasone is an inhaled corticosteroid
Fluticasone 220 mcgDrug
Also called Flovent® 220 mcg
Fluticasone is an inhaled corticosteroid
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone 44 mcg | Active comparator | Fluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms. Receives: Drug: Fluticasone 44 mcg |
| Fluticasone 220 mcg | Active comparator | Fluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms. Receives: Drug: Fluticasone 220 mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Exacerbations
The primary outcome is the rate of severe asthma exacerbations treated with oral corticosteroids during the 48 week treatment period.
Measured: end of 48 week treatment period
Secondary outcomes (4)
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.
Measured: end of 48 week treatment period
Yellow Zone Albuterol Use
Use of albuterol rescue medication during 7-day yellow zone episodes.
Measured: end of 48 week treatment period
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.
Measured: end of 48 week treatment period
Number of Participants Hospitalized for Asthma
Number of participants hospitalized for asthma during the 48 week treatment period.
Measured: end of 48 week treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startJul 2014
- Primary completion21 Apr 2017
- Study completion21 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dave mauger, Milton S. Hershey Medical Center
- Investigators
- William Busse, MD, Study chair, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066129
- Sponsor's protocol ID
- AsthmaNet 008
- Acronym
- STICS
- Status last verified
- Jun 2018
- First submitted
- 17 Feb 2014
- Last updated
- 11 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Gomez LF, Kinnee E, Kaufman JD, Young MT, Fitzpatrick AM, Phipatanakul W, Mauger DT, McClure LA, Bilal U, Holguin F, Clougherty JE. Modification of asthma treatment efficacy by healthcare access: A reanalysis of AsthmaNet Step-Up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS) clinical trial. Respir Med. 2024 Nov-Dec;234:107853. doi: 10.1016/j.rmed.2024.107853. Epub 2024 Nov 5.
PubMed 39510322Yuan H, Liu Z, Dong J, Bacharier LB, Jackson D, Mauger D, Boushey H, Castro M, Durack J, Huang YJ, Lemanske RF Jr, Storch GA, Weinstock GM, Wylie K, Covar R, Fitzpatrick AM, Phipatanakul W, Robison RG, Beigelman A, Zhou Y. The Fungal Microbiome of the Upper Airway Is Associated With Future Loss of Asthma Control and Exacerbation Among Children With Asthma. Chest. 2023 Aug;164(2):302-313. doi: 10.1016/j.chest.2023.03.034. Epub 2023 Mar 30.
PubMed 37003356Jackson DJ, Bacharier LB, Mauger DT, Boehmer S, Beigelman A, Chmiel JF, Fitzpatrick AM, Gaffin JM, Morgan WJ, Peters SP, Phipatanakul W, Sheehan WJ, Cabana MD, Holguin F, Martinez FD, Pongracic JA, Baxi SN, Benson M, Blake K, Covar R, Gentile DA, Israel E, Krishnan JA, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Long D, Ly N, Marbin J, Moy JN, Myers RE, Olin JT, Raissy HH, Robison RG, Ross K, Sorkness CA, Lemanske RF Jr; National Heart, Lung, and Blood Institute AsthmaNet. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):891-901. doi: 10.1056/NEJMoa1710988. Epub 2018 Mar 3.
PubMed 29504498
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations
- ClinicalTrials.gov ID
- NCT02066129
- Acronym / sponsor ID
- STICS / AsthmaNet 008
- Conditions
- Asthma
- Keywords
- Asthma, Fluticasone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- 21 Apr 2017 (actual)
- Study completion
- 21 Apr 2017 (actual)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Posted 11 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone 44 mcg | Active comparator | Drug: Fluticasone 44 mcgFluticasone 44 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms. |
| Fluticasone 220 mcg | Active comparator | Drug: Fluticasone 220 mcgFluticasone 220 mcg 2 puffs twice daily for 7 days initiated at the onset of "yellow zone" symptoms. |
Who may qualify
- Ages
- 5 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone 44 mcgAlso: Flovent® 44 mcgFluticasone is an inhaled corticosteroid | Drug | Fluticasone 44 mcg |
| Fluticasone 220 mcgAlso: Flovent® 220 mcgFluticasone is an inhaled corticosteroid | Drug | Fluticasone 220 mcg |
Primary outcome
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.
4 secondary outcomes
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
Number of Participants Hospitalized for Asthma
Time frame: end of 48 week treatment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39510322Gomez LF, Kinnee E, Kaufman JD, Young MT, Fitzpatrick AM, Phipatanakul W, Mauger DT, McClure LA, Bilal U, Holguin F, Clougherty JE. Modification of asthma treatment efficacy by healthcare access: A reanalysis of AsthmaNet Step-Up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations (STICS) clinical trial. Respir Med. 2024 Nov-Dec;234:107853. doi: 10.1016/j.rmed.2024.107853. Epub 2024 Nov 5.
- Derived from this study: PubMed 37003356Yuan H, Liu Z, Dong J, Bacharier LB, Jackson D, Mauger D, Boushey H, Castro M, Durack J, Huang YJ, Lemanske RF Jr, Storch GA, Weinstock GM, Wylie K, Covar R, Fitzpatrick AM, Phipatanakul W, Robison RG, Beigelman A, Zhou Y. The Fungal Microbiome of the Upper Airway Is Associated With Future Loss of Asthma Control and Exacerbation Among Children With Asthma. Chest. 2023 Aug;164(2):302-313. doi: 10.1016/j.chest.2023.03.034. Epub 2023 Mar 30.
- Derived from this study: PubMed 29504498Jackson DJ, Bacharier LB, Mauger DT, Boehmer S, Beigelman A, Chmiel JF, Fitzpatrick AM, Gaffin JM, Morgan WJ, Peters SP, Phipatanakul W, Sheehan WJ, Cabana MD, Holguin F, Martinez FD, Pongracic JA, Baxi SN, Benson M, Blake K, Covar R, Gentile DA, Israel E, Krishnan JA, Kumar HV, Lang JE, Lazarus SC, Lima JJ, Long D, Ly N, Marbin J, Moy JN, Myers RE, Olin JT, Raissy HH, Robison RG, Ross K, Sorkness CA, Lemanske RF Jr; National Heart, Lung, and Blood Institute AsthmaNet. Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med. 2018 Mar 8;378(10):891-901. doi: 10.1056/NEJMoa1710988. Epub 2018 Mar 3.
- AsthmaNetLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Busse, MD study chair
University of Wisconsin, Madison
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone 44 mcg and Fluticasone 220 mcg in people with Asthma, run by Milton S. Hershey Medical Center at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Exacerbations (time frame: end of 48 week treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066129, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2018.