title: Efficacy of nasal mometasone for the treatment of chronic sinonasal disease in patients with inadequately controlled asthma.
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.
authors.affiliation: Department of Medicine, University of Vermont, Burlington, Vt. Electronic address: anne.dixon@vtmednet.org.
authors.forename: Anne E
authors.initials: AE
authors.lastname: Dixon
authors.affiliation: Department of Medicine, Washington University School of Medicine, St Louis, Mo.
authors.forename: Mario
authors.initials: M
authors.lastname: Castro
authors.affiliation: The Thalheim Asthma Center Hofstra, North Shore-Long Island Jewish School of Medicine, New Hyde Park, NY.
authors.forename: Rubin I
authors.initials: RI
authors.lastname: Cohen
authors.affiliation: Arizona Respiratory Center, Mel and Enid Zuckerman College of Public Health, University of Arizona, Tucson, Ariz.
authors.forename: Lynn B
authors.initials: LB
authors.lastname: Gerald
authors.affiliation: Department of Epidemiology, Johns Hopkins University, Baltimore, Md.
authors.forename: Janet T
authors.initials: JT
authors.lastname: Holbrook
authors.affiliation: Department of Medicine, University of Vermont, Burlington, Vt.
authors.forename: Charles G
authors.initials: CG
authors.lastname: Irvin
authors.affiliation: Department of Medicine, University of South Florida, Tampa, Fla.
authors.forename: Shyam
authors.initials: S
authors.lastname: Mohapatra
authors.affiliation: Section on Pulmonary, Critical Care, Allergy & Immunologic Diseases, Wake Forest University, Winston-Salem, NC.
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Peters
authors.affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Md.
authors.forename: Sobharani
authors.initials: S
authors.lastname: Rayapudi
authors.affiliation: Department of Biostatistics, Johns Hopkins University, Baltimore, Md.
authors.forename: Elizabeth A
authors.initials: EA
authors.lastname: Sugar
authors.affiliation: Department of Medicine, Johns Hopkins University, Baltimore, Md.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wise
mesh_terms: D000281:Administration, Intranasal; D000293:Adolescent; D000328:Adult; D000893:Anti-Inflammatory Agents / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology / Q000523:psychology; D002648:Child; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000068656:Mometasone Furoate; D010256:Paranasal Sinuses / Q000187:drug effects* / Q000503:physiopathology; D011244:Pregnadienediols / Q000627:therapeutic use*; D011788:Quality of Life; D012129:Respiratory Function Tests; D016896:Treatment Outcome
chemical_list: D000893:Anti-Inflammatory Agents; D011244:Pregnadienediols; D000068656:Mometasone Furoate
keywords: Asthma; asthma control; asthma exacerbation; lung function; rhinitis; sinonasal; sinusitis