Study of Asthma and Nasal Steroids (STAN)
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September 2010 – June 2015
August 30, 2016
Clinical Trial URLs
Primary Publication URLs
Commercial Use Data Restrictions No
Data Restrictions Based On Area Of Research No
To determine if treatment of chronic sinonasal disease with nasal corticosteroids improves asthma control in children and adults.
Poor asthma control is a significant cause of morbidity. Chronic sinonasal diseases, such as rhinitis and sinusitis, are commonly reported in asthma patients. A number of mechanisms link sinonasal disease and asthma, which may represent a common immune disorder affecting the whole respiratory system. However, while acute and severe sinonasal disease clearly warrant treatment directed towards disease in the upper airway, it was not clear at the time of the trial if treating chronic sinonasal disease improves asthma control. The purpose of this study was to determine the efficacy of treating chronic sinonasal disease in children and adults with inadequately controlled asthma, as is common medical practice.
Eligible participants were at least 6 years old with a history of physician diagnosed asthma. Within two years of enrollment, participants must have had either a positive methacholine challenge, or documentation of at least 12% and 200 cc increase in FEV1 with bronchodilator. Participants also had poor asthma control, defined as a score of 19 or less on the Childhood Asthma Control Test (c-ACT) or Asthma Control Test (ACT), and chronic symptoms of rhinitis and sinusitis as measured by a mean score of 1 or greater on the Sino-Nasal Questionnaire.
A total of 237 adults and 151 children completed screening and were randomized. 199 participants were in the placebo group and 189 were in the mometasone group. 319 participants completed the study.
After a two-week run-in period, participants were randomized in a double-blind fashion to mometasone or placebo, and followed for 24 weeks while on treatment. Randomization was stratified by center and age, 6 to 17 years or 18 or older, using permuted blocks of varying sizes. Participants aged 12 years and older received 2 sprays of mometasone (50 mcg per spray) or placebo per nostril daily, and those age 6 to 11 years received 1 spray per nostril daily.
Participants were asked to refrain from taking non-study medications for their nasal symptoms, but continued usual asthma medications during the trial. After randomization, participants kept daily diaries to record morning peak expiratory flow, medication use and asthma symptoms. Assessments were conducted at 4, 12 and 24 weeks, including an interval medical history interview, asthma and sinus symptoms questionnaires, and spirometry. At baseline and the 24 week follow-up visits, exhaled nitric oxide was measured and methacholine challenge testing was performed. Allergen skin testing and the sinonasal questionnaire were administered at baseline.
The primary outcome measure was the change in Childhood Asthma Control Test (cACT for children under 12 years of age) or Asthma Control Test (ACT for those ages 12 and older) at 24 weeks from baseline.
There was no difference in the cACT or the ACT in those assigned to mometasone versus placebo. Treatment of chronic sinonasal disease with nasal corticosteroids for 24 weeks did not improve asthma control.
J Allergy Clin Immunol. 2015 Mar;135(3):701-9.e5. doi: 10.1016/j.jaci.2014.06.038. Epub 2014 Aug 28.
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Resources AvailableStudy Datasets Only
- Data Dictionary (PDF - 587.2 KB)
- Forms (PDF - 1.5 MB)
- Manual of Operations (PDF - 2.0 MB)
- Protocol (PDF - 163.9 KB)
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