Efficacy of nasal mometasone for the treatment of chronic sinonasal disease in patients with inadequately controlled asthma - 05/03/15
American Lung Association–Asthma Clinical Research Centers' Writing Committee:
Anne E. Dixon, MA, BM BCh a, ⁎
, Mario Castro, MD, MPH b, Rubin I. Cohen, MD c, Lynn B. Gerald, PhD, MPH d, Janet T. Holbrook, PhD e, Charles G. Irvin, PhD a, Shyam Mohapatra, PhD f, Stephen P. Peters, MD g, Sobharani Rayapudi, MD h, Elizabeth A. Sugar, PhD i, Robert A. Wise, MD hAbstract |
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.
Le texte complet de cet article est disponible en PDF.Key words : Asthma, rhinitis, sinusitis, sinonasal, asthma control, lung function, asthma exacerbation
Abbreviations used : ACT, cACT, ΔM − ΔP, SNOT-22
Plan
| Supported by grants from the National Heart, Lung, and Blood Institute (UO1HL089464 and U01 HL089510, UL1 TR000448) and the American Lung Association. Study drug and placebo were provided by Merck. |
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| Disclosure of potential conflict of interest: This study was funded by the National Heart, Lung, and Blood Institute and the American Lung Association. Study materials were provided by Merck. A. E. Dixon's institution has received funding from the National Institutes of Health (NIH) and Merck; has received consultancy fees from Roche; has received grants or has grants pending from Pfizer; and receives royalties from Springer. M. Castro's institution has received funding from the National Institutes of Health and has received grants or has grants pending from Boston Scientific, Amgen, Ception, Cephalon, Teva, Genentech, MedImmune, Merck, Novartis, GlaxoSmithKline, Sanofi Aventis, Vectura, Next Bio, and KalosBios; has received consultancy fees from Asthmatx/Boston Scientific, Genentech, IPS/Holaira, and Neostem; has received payment for delivering lectures from GlaxoSmithKline, Genentech, Boston Scientific, Boehringer Ingelheim, and Teva; receives royalties from Elsevier; and has stock/stock options from Sparo. R. I. Cohen's institution has received funding from the American Lung Association Asthma Clinical Research Centers. C. G. Irvin has received consultancy fees from TEVA; has received grants or has grants pending from Hydra Bioscience; and receives royalties from UpToDate. S. P. Peters has received consultancy fees from the Coordination Center at Johns Hopkins, AstraZeneca, Aerocrine, Airsonett AB, Boehringer Ingelheim, GlaxoSmithKline, Merck, Novartis, Ono Pharmaceuticals, Pfizer, Sunovion, Targacept, TEVA, Pharmaceutical Product Development, and Quintiles; has received payment for delivering lectures from Integrity CE; and receives royalties from UpToDate. R. A. Wise's institution has received funding from Merck, as well as consultancy fees from AstraZeneca, Merck, GlaxoSmithKline, Boehringer-Ingelheim, Novartis, Pfizer, Mylan, Roche, Janssen, Pulmonx, Spiration, Intermune, MedImmune, Sunovion, and Forest and has received support for travel and other meeting-related expenses from Forest. The rest of the authors declare that they no relevant conflicts of interest. |
Vol 135 - N° 3
P. 701 - mars 2015 Retour au numéro
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