Anne E Dixon1, Mario Castro2, Rubin I Cohen3, Lynn B Gerald4, Janet T Holbrook5, Charles G Irvin6, Shyam Mohapatra7, Stephen P Peters8, Sobharani Rayapudi9, Elizabeth A Sugar10, Robert A Wise9. 1. Department of Medicine, University of Vermont, Burlington, Vt. Electronic address: anne.dixon@vtmednet.org. 2. Department of Medicine, Washington University School of Medicine, St Louis, Mo. 3. The Thalheim Asthma Center Hofstra, North Shore-Long Island Jewish School of Medicine, New Hyde Park, NY. 4. Arizona Respiratory Center, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Ariz. 5. Department of Epidemiology, Johns Hopkins University, Baltimore, Md. 6. Department of Medicine, University of Vermont, Burlington, Vt. 7. Department of Medicine, University of South Florida, Tampa, Fla. 8. Section on Pulmonary, Critical Care, Allergy & Immunologic Diseases, Wake Forest University, Winston-Salem, NC. 9. Department of Medicine, Johns Hopkins University, Baltimore, Md. 10. Department of Biostatistics, Johns Hopkins University, Baltimore, Md.
Abstract
BACKGROUND:Chronic sinonasal disease is common in asthmatic patients and associated with poor asthma control; however, there are no long-term trials addressing whether chronic treatment of sinonasal disease improves asthma control. OBJECTIVE: We sought to determine whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control, as measured by the Childhood Asthma Control Test and Asthma Control Test in children and adults, respectively. METHODS: A 24-week multicenter, randomized, placebo-controlled, double-blind trial of placebo versus nasal mometasone in adults and children with inadequately controlled asthma was performed. Treatments were randomly assigned, with concealment of allocation. RESULTS:Two hundred thirty-seven adults and 151 children were randomized to nasal mometasone versus placebo, and 319 participants completed the study. There was no difference in the Childhood Asthma Control Test score (difference in change with mometasone - change with placebo [ΔM - ΔP], -0.38; 95% CI, -2.19 to 1.44; P = .68; age 6-11 years) or the Asthma Control Test score (ΔM - ΔP, 0.51; 95% CI, -0.46 to 1.48; P = .30; age ≥12 years) in those assigned to mometasone versus placebo. In children and adolescents (age 6-17 years) there was no difference in asthma or sinus symptoms but a decrease in episodes of poorly controlled asthma defined by a decrease in peak flow. In adults there was a small difference in asthma symptoms measured by using the Asthma Symptom Utility Index (ΔM - ΔP, 0.06; 95% CI, 0.01 to 0.11; P < .01) and in nasal symptoms (sinus symptom score ΔM - ΔP, -3.82; 95% CI, -7.19 to -0.45; P = .03) but no difference in asthma quality of life, lung function, or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo. CONCLUSIONS: Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control. Treatment of sinonasal disease in asthmatic patients should be determined by the need to treat sinonasal disease rather than to improve asthma control.
RCT Entities:
BACKGROUND:Chronic sinonasal disease is common in asthmatic patients and associated with poor asthma control; however, there are no long-term trials addressing whether chronic treatment of sinonasal disease improves asthma control. OBJECTIVE: We sought to determine whether treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control, as measured by the Childhood Asthma Control Test and Asthma Control Test in children and adults, respectively. METHODS: A 24-week multicenter, randomized, placebo-controlled, double-blind trial of placebo versus nasalmometasone in adults and children with inadequately controlled asthma was performed. Treatments were randomly assigned, with concealment of allocation. RESULTS: Two hundred thirty-seven adults and 151 children were randomized to nasalmometasone versus placebo, and 319 participants completed the study. There was no difference in the Childhood Asthma Control Test score (difference in change with mometasone - change with placebo [ΔM - ΔP], -0.38; 95% CI, -2.19 to 1.44; P = .68; age 6-11 years) or the Asthma Control Test score (ΔM - ΔP, 0.51; 95% CI, -0.46 to 1.48; P = .30; age ≥12 years) in those assigned to mometasone versus placebo. In children and adolescents (age 6-17 years) there was no difference in asthma or sinus symptoms but a decrease in episodes of poorly controlled asthma defined by a decrease in peak flow. In adults there was a small difference in asthma symptoms measured by using the Asthma Symptom Utility Index (ΔM - ΔP, 0.06; 95% CI, 0.01 to 0.11; P < .01) and in nasal symptoms (sinus symptom score ΔM - ΔP, -3.82; 95% CI, -7.19 to -0.45; P = .03) but no difference in asthma quality of life, lung function, or episodes of poorly controlled asthma in adults assigned to mometasone versus placebo. CONCLUSIONS: Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks does not improve asthma control. Treatment of sinonasal disease in asthmatic patients should be determined by the need to treat sinonasal disease rather than to improve asthma control.
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