Joe K Gerald1, Lynn B Gerald2, Monica M Vasquez2, Wayne J Morgan3, Susan J Boehmer4, Robert F Lemanske5, David T Mauger4, Robert C Strunk6, Stanley J Szefler7, Robert S Zeiger8, Leonard B Bacharier6, Elizabeth Bade9, Ronina A Covar10, Theresa W Guilbert5, Hengameh Heidarian-Raissy11, H William Kelly11, Jonathan Malka-Rais12, Christine A Sorkness5, Lynn M Taussig13, Vernon M Chinchilli4, Fernando D Martinez3. 1. Mel and Enid Zuckerman College of Public Health, University of Arizona, Ariz, Tucson. Electronic address: geraldj@email.arizona.edu. 2. Mel and Enid Zuckerman College of Public Health and Arizona Respiratory Center, University of Arizona, Tucson, Ariz. 3. Arizona Respiratory Center, College of Medicine, University of Arizona, Tucson, Ariz. 4. Department of Public Health Sciences, Penn State Hershey College of Medicine, Hershey, Pa. 5. University of Wisconsin School of Medicine and Public Health, Madison, Wis. 6. Department of Pediatrics, Washington University School of Medicine, St Louis, Mo. 7. Department of Pediatrics, Pulmonary Section, The Breathing Institute, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo. 8. Department of Allergy, Kaiser Permanente Southern California, and Department of Pediatrics, University of California, San Diego, San Diego and La Jolla, Calif. 9. University of Wisconsin, Aurora UW Medical Group, Milwaukee, Wis. 10. Department of Pediatrics, National Jewish Health, Denver, Colo. 11. Department of Pediatrics, University of New Mexico, Albuquerque, NM. 12. Pediatric Associates, Miami, Fla. 13. University of Denver, Denver, Colo.
Abstract
BACKGROUND:Inhaled corticosteroids are recommended as first-line therapy for children with mild persistent asthma; however, specific patient characteristics may modify the treatment response. OBJECTIVE: Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. METHODS:Children aged 6 to 18 years with mild persistent asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 μg of beclomethasone twice daily. Rescue treatment consisted of 40 μg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. RESULTS:Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and history of oral corticosteroid use in the year before enrollment. As measured by asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and incomplete run-in asthma control. CONCLUSIONS:Children with mild persistent asthma who have markers of atopic asthma or who have greater asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy.
RCT Entities:
BACKGROUND: Inhaled corticosteroids are recommended as first-line therapy for children with mild persistent asthma; however, specific patient characteristics may modify the treatment response. OBJECTIVE: Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. METHODS:Children aged 6 to 18 years with mild persistent asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 μg of beclomethasone twice daily. Rescue treatment consisted of 40 μg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. RESULTS: Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and history of oral corticosteroid use in the year before enrollment. As measured by asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and incomplete run-in asthma control. CONCLUSIONS:Children with mild persistent asthma who have markers of atopic asthma or who have greater asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy.
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