Linda Rogers1, Elizabeth A Sugar2, Kathryn Blake3, Mario Castro4, Emily Dimango5, Nicola A Hanania6, Kyle I Happel7, Stephen P Peters8, Joan Reibman9, Joy Saams2, W Gerald Teague10, Robert A Wise11, Janet T Holbrook2. 1. Icahn School of Medicine at Mt Sinai, New York, NY. 2. Johns Hopkins Bloomberg School of Public Health, Baltimore, Md. 3. Nemours Children's Health System, Jacksonville, Fla. 4. Washington University School of Medicine, St Louis, Mo. 5. Columbia University College of Physicians and Surgeons, New York, NY. 6. Baylor College of Medicine, Houston, Texas. 7. Louisiana State University School of Medicine, New Orleans, La. 8. Wake Forest University School of Medicine, Winston-Salem, NC. 9. New York University School of Medicine, New York, NY. 10. University of Virginia School of Medicine, Charlottesville, Va. 11. Johns Hopkins University School of Medicine, Baltimore, Md. Electronic address: rwise@jhmi.edu.
Abstract
BACKGROUND: Stepping down therapy when asthma is well controlled on combination inhaled corticosteroids (ICSs) and long-acting beta-agonists (LABAs) is recommended, but it is not known whether lowering the ICS dose or stopping LABA is superior. OBJECTIVE: To evaluate whether step-down therapy with LABA is superior to one without; and, secondarily, to evaluate whether reducing the ICS dose while maintaining LABA is noninferior to remaining on stable-ICS/LABA. METHODS: The study was a randomized, double-masked 3-arm parallel group trial in participants aged 12 years or older. Following an 8-week run-in, 459 participants were randomly assigned to continue medium-dose ICS/LABA, reduced-dose ICS/LABA, or ICS alone (LABA-step-off) and followed for 48 weeks. The primary outcome was time to treatment failure, a composite of health care utilization, systemic corticosteroid use, increase in rescue therapy, decline in lung function, or participant or physician decision. RESULTS:Time to treatment failure did not differ significantly between reduced- ICS/LABA and LABA-step-off (hazard ratio, 1.07; 95.3% CI, 0.69-1.65, P = .76). Nor was there a difference between stable-ICS/LABA and reduced-ICS/LABA (hazard ratio, 1.11; 95% CI, 0.70-1.76; P = .67), but the 10% noninferiority margin was exceeded. Lung function declines and hospitalization rates were significantly greater in the LABA-step-off group. CONCLUSIONS: The 2 step-down regimens did not differ in terms of treatment failure, although stopping LABA was associated with a decline in lung function and more hospitalizations. There was no evidence to support the noninferiority of reduced-ICS/LABA as compared with stable-ICS/LABA.
RCT Entities:
BACKGROUND: Stepping down therapy when asthma is well controlled on combination inhaled corticosteroids (ICSs) and long-acting beta-agonists (LABAs) is recommended, but it is not known whether lowering the ICS dose or stopping LABA is superior. OBJECTIVE: To evaluate whether step-down therapy with LABA is superior to one without; and, secondarily, to evaluate whether reducing the ICS dose while maintaining LABA is noninferior to remaining on stable-ICS/LABA. METHODS: The study was a randomized, double-masked 3-arm parallel group trial in participants aged 12 years or older. Following an 8-week run-in, 459 participants were randomly assigned to continue medium-dose ICS/LABA, reduced-dose ICS/LABA, or ICS alone (LABA-step-off) and followed for 48 weeks. The primary outcome was time to treatment failure, a composite of health care utilization, systemic corticosteroid use, increase in rescue therapy, decline in lung function, or participant or physician decision. RESULTS: Time to treatment failure did not differ significantly between reduced- ICS/LABA and LABA-step-off (hazard ratio, 1.07; 95.3% CI, 0.69-1.65, P = .76). Nor was there a difference between stable-ICS/LABA and reduced-ICS/LABA (hazard ratio, 1.11; 95% CI, 0.70-1.76; P = .67), but the 10% noninferiority margin was exceeded. Lung function declines and hospitalization rates were significantly greater in the LABA-step-off group. CONCLUSIONS: The 2 step-down regimens did not differ in terms of treatment failure, although stopping LABA was associated with a decline in lung function and more hospitalizations. There was no evidence to support the noninferiority of reduced-ICS/LABA as compared with stable-ICS/LABA.
Authors: Monica Tang; Robert J Henderson; Janet T Holbrook; Loretta G Que; Anne M Mathews; Robert A Wise; Anne E Dixon; Stephen P Peters; Linda Rogers; Lewis J Smith; W Gerald Teague; Jason E Lang Journal: J Allergy Clin Immunol Pract Date: 2018-10-09
Authors: Sandra R Wilson; Robert A Wise; Mario Castro; Michael J Mulligan; Estela Ayala; Alan Chausow; Qiwen Huang; Santosh Gummidipundi Journal: J Allergy Clin Immunol Date: 2018-05-04 Impact factor: 10.793
Authors: Matthew C H Rohn; Danielle R Stevens; Jenna Kanner; Carrie Nobles; Zhen Chen; Katherine L Grantz; Seth Sherman; William A Grobman; Rajesh Kumar; Joseph Biggio; Pauline Mendola Journal: Am J Perinatol Date: 2021-04-21 Impact factor: 3.079
Authors: Sonali Bose; Christian Bime; Robert J Henderson; Kathryn V Blake; Mario Castro; Emily DiMango; Nicola A Hanania; Janet T Holbrook; Charles G Irvin; Monica Kraft; Stephen P Peters; Joan Reibman; Elizabeth A Sugar; Kaharu Sumino; Robert A Wise; Linda Rogers Journal: J Allergy Clin Immunol Pract Date: 2020-07-18