Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
574 participants
INTERVENTIONAL
2014-02-28
2017-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Crossover sequence 1
Flovent Diskus® 250 mcg,followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 100/50 mcg
Flovent Diskus® 100 mcg
Flovent is an ICS
Flovent Diskus® 250 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 2
Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Flovent Diskus® 100 mcg
Flovent Diskus® 100 mcg
Flovent is an ICS
Flovent Diskus® 250 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 3
Flovent Diskus® 100 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Flovent Diskus® 100 mcg
Flovent is an ICS
Flovent Diskus® 250 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 4
Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 100 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg
Flovent Diskus® 100 mcg
Flovent is an ICS
Flovent Diskus® 250 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 5
Flovent Diskus® 500 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 100/50 mcg
Flovent Diskus® 250 mcg
Flovent is an ICS
Flovent Diskus® 500 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 6
Advair Diskus® 250/50 mcg, followed by Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 500 mcg, followed by Flovent Diskus® 250 mcg
Flovent Diskus® 250 mcg
Flovent is an ICS
Flovent Diskus® 500 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 7
Flovent Diskus® 250 mcg, followed by Flovent Diskus® 500 mcg, followed by Advair Diskus® 100/50 mcg, followed by Advair Diskus® 250/50 mcg
Flovent Diskus® 250 mcg
Flovent is an ICS
Flovent Diskus® 500 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Crossover sequence 8
Advair Diskus® 100/50 mcg, followed by Flovent Diskus® 250 mcg, followed by Advair Diskus® 250/50 mcg, followed by Flovent Diskus® 500 mcg
Flovent Diskus® 250 mcg
Flovent is an ICS
Flovent Diskus® 500 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Interventions
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Flovent Diskus® 100 mcg
Flovent is an ICS
Flovent Diskus® 250 mcg
Flovent is an ICS
Flovent Diskus® 500 mcg
Flovent is an ICS
Advair Diskus® 100/50 mcg
Advair is an ICS/LABA combination
Advair Diskus® 250/50 mcg
Advair is an ICS/LABA combination
Eligibility Criteria
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Inclusion Criteria
2. Able to perform reproducible spirometry according to ATS criteria.
3. Clinical history consistent with asthma.
4. Baseline FEV1≥40% of predicted and/or post-bronchodilator FEV1≥40% of predicted.
5. Asthma confirmed either by: (1) Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR (2) PC20FEV1 ≤ 16 mg/ml OR (3) an absolute relative change in %predicted FEV1 of ≥ 12% over two measurements documented by repeat spirogram over the previous year
6. Either: A) inadequately controlled on low-, medium- or high-dose ICS monotherapy, or low- or medium-dose ICS/LABA, or B) well-controlled on medium- or high-dose ICS monotherapy, or low-, medium- or high-dose ICS/LABA. Inadequate asthma control will be defined as an ACT/c-ACT score \<20; well-controlled asthma will be defined as an ACT/c-ACT score ≥20.
7. Stable asthma controller therapy dose (ICS or ICS/LABA) for the 2 weeks prior to enrollment.
8. Non-smoker (total lifetime smoking history \< 5 pack-years if \<18, or \<10 pack-years if ≥18 years of age; no smoking for at least 1 year).
9. For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
Exclusion Criteria
2. Current or prior use of medications known to significantly interact with corticosteroid disposition within the two-week period preceding enrollment.
3. Unwilling to provide a blood sample for DNA extraction and genetic analysis.
4. Major medical problems prohibiting study participation, i.e. presence of chronic or active lung disease other than asthma or history of unstable 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 or that would place the participant at increased risk.
5. Systemic corticosteroid treatment for any condition within 4 weeks of enrollment or more than five courses of systemic corticosteroids in the past year.
6. History of a life-threatening asthma exacerbation requiring intubation, mechanical ventilation, or resulting in a hypoxic seizure within the last 2 years.
7. History of a respiratory tract infection within 4 weeks of enrollment.
8. If a female of child-bearing potential, failure to practice abstinence or use an acceptable birth control method.
9. Pregnancy or lactation or planning to get pregnant during the course of the trial.
10. Receiving hyposensitization therapy other than an established maintenance regimen defined as a continuous regimen for ≥ 3 months prior to enrollment.
11. Participation in an intervention trial or use of investigative drugs in the past 30 days or plans to enroll in such a trial during the study.
5 Years
ALL
No
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Milton S. Hershey Medical Center
OTHER
Responsible Party
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dave mauger
Principal Investigator, AsthmaNet Data Coordinating Center
Principal Investigators
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William Busse, MD
Role: STUDY_CHAIR
University of Wisconsin, Madison
Locations
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University of Arizona College of Medicine
Tucson, Arizona, United States
Children's Hospital & Research Center Oakland
Oakland, California, United States
UCSF Benioff Children's Hospital
San Francisco, California, United States
University of California - San Francisco
San Francisco, California, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Nemours Children's Clinic
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Ann and Robert H. Lurie Children's Hospital
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Children's Hospital Boston
Boston, Massachusetts, United States
St. Louis Children's Hospital
St Louis, Missouri, United States
Washington University
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
Columbia University Medical Center
New York, New York, United States
Duke University School of Medicine
Durham, North Carolina, United States
North Carolina Clinical Research
Raleigh, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Rainbow Babies and Children's Hospital, Case Western Reserve University
Cleveland, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States
University of Wisconsin-Madison
Madison, Wisconsin, United States
Center for Urban Population Health
Milwaukee, Wisconsin, United States
Countries
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References
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Wechsler ME, Szefler SJ, Ortega VE, Pongracic JA, Chinchilli V, Lima JJ, Krishnan JA, Kunselman SJ, Mauger D, Bleecker ER, Bacharier LB, Beigelman A, Benson M, Blake KV, Cabana MD, Cardet JC, Castro M, Chmiel JF, Covar R, Denlinger L, DiMango E, Fitzpatrick AM, Gentile D, Grossman N, Holguin F, Jackson DJ, Kumar H, Kraft M, LaForce CF, Lang J, Lazarus SC, Lemanske RF Jr, Long D, Lugogo N, Martinez F, Meyers DA, Moore WC, Moy J, Naureckas E, Olin JT, Peters SP, Phipatanakul W, Que L, Raissy H, Robison RG, Ross K, Sheehan W, Smith LJ, Solway J, Sorkness CA, Sullivan-Vedder L, Wenzel S, White S, Israel E; NHLBI AsthmaNet. Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma. N Engl J Med. 2019 Sep 26;381(13):1227-1239. doi: 10.1056/NEJMoa1905560.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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AsthmaNet
Other Identifiers
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AsthmaNet 006
Identifier Type: -
Identifier Source: org_study_id
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