TY - JOUR
T1 - Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults
T2 - a randomised controlled trial
AU - Szefler, Stanley J.
AU - Mitchell, Herman
AU - Sorkness, Christine A.
AU - Gergen, Peter J.
AU - O'Connor, George T.
AU - Morgan, Wayne J.
AU - Kattan, Meyer
AU - Pongracic, Jacqueline A.
AU - Teach, Stephen J.
AU - Bloomberg, Gordon R.
AU - Eggleston, Peyton A.
AU - Gruchalla, Rebecca S.
AU - Kercsmar, Carolyn M.
AU - Liu, Andrew H.
AU - Wildfire, Jeremy J.
AU - Curry, Matthew D.
AU - Busse, William W.
N1 - Funding Information:
The study was funded by the Division of Allergy, Immunology, and Transplantation at the US National Institute of Allergy and Infectious Diseases, National Institutes of Health, under Contracts number NO1-AI-25496 and NO1-AI-25482, and by the National Center for Research Resources, National Institutes of Health, under grant M01 RR00533. GlaxoSmithKline donated study drugs and Lincoln Diagnostics donated skin-testing materials. We thank all study staff and consultants, study participants, and their families.
PY - 2008
Y1 - 2008
N2 - Background: Preliminary evidence is equivocal about the role of exhaled nitric oxide (NO) in clinical asthma management. We aimed to assess whether measurement of exhaled NO, as a biomarker of airway inflammation, could increase the effectiveness of asthma treatment, when used as an adjunct to clinical care based on asthma guidelines for inner-city adolescents and young adults. Methods: We did a randomised, double-blind, parallel-group trial at ten centres in the USA. We screened 780 inner-city patients, aged 12-20 years, who had persistent asthma. All patients completed a run-in period of 3 weeks on a regimen based on standard treatment. 546 eligible participants who adhered to treatment during this run-in period were then randomly assigned to 46 weeks of either standard treatment, based on the guidelines of the National Asthma Education and Prevention Program (NAEPP), or standard treatment modified on the basis of measurements of fraction of exhaled NO. The primary outcome was the number of days with asthma symptoms. We analysed patients on an intention-to-treat basis. This trial is registered with clinicaltrials.gov, number NCT00114413. Findings: During the 46-week treatment period, the mean number of days with asthma symptoms did not differ between the treatment groups (1·93 [95% CI 1·74 to 2·11] in the NO monitoring group vs 1·89 [1·71 to 2·07] in the control group; difference 0·04 [-0·22 to 0·29], p=0·780). Other symptoms, pulmonary function, and asthma exacerbations did not differ between groups. Patients in the NO monitoring group received higher doses of inhaled corticosteroids (difference 119 μg per day, 95% CI 49 to 189, p=0·001) than controls. Adverse events did not differ between treatment groups (p>0·1 for all adverse events). Interpretation: Conventional asthma management resulted in good control of symptoms in most participants. The addition of fraction of exhaled NO as an indicator of control of asthma resulted in higher doses of inhaled corticosteroids, without clinically important improvements in symptomatic asthma control. Funding: US National Institute of Allergy and Infectious Diseases, US National Institutes of Health.
AB - Background: Preliminary evidence is equivocal about the role of exhaled nitric oxide (NO) in clinical asthma management. We aimed to assess whether measurement of exhaled NO, as a biomarker of airway inflammation, could increase the effectiveness of asthma treatment, when used as an adjunct to clinical care based on asthma guidelines for inner-city adolescents and young adults. Methods: We did a randomised, double-blind, parallel-group trial at ten centres in the USA. We screened 780 inner-city patients, aged 12-20 years, who had persistent asthma. All patients completed a run-in period of 3 weeks on a regimen based on standard treatment. 546 eligible participants who adhered to treatment during this run-in period were then randomly assigned to 46 weeks of either standard treatment, based on the guidelines of the National Asthma Education and Prevention Program (NAEPP), or standard treatment modified on the basis of measurements of fraction of exhaled NO. The primary outcome was the number of days with asthma symptoms. We analysed patients on an intention-to-treat basis. This trial is registered with clinicaltrials.gov, number NCT00114413. Findings: During the 46-week treatment period, the mean number of days with asthma symptoms did not differ between the treatment groups (1·93 [95% CI 1·74 to 2·11] in the NO monitoring group vs 1·89 [1·71 to 2·07] in the control group; difference 0·04 [-0·22 to 0·29], p=0·780). Other symptoms, pulmonary function, and asthma exacerbations did not differ between groups. Patients in the NO monitoring group received higher doses of inhaled corticosteroids (difference 119 μg per day, 95% CI 49 to 189, p=0·001) than controls. Adverse events did not differ between treatment groups (p>0·1 for all adverse events). Interpretation: Conventional asthma management resulted in good control of symptoms in most participants. The addition of fraction of exhaled NO as an indicator of control of asthma resulted in higher doses of inhaled corticosteroids, without clinically important improvements in symptomatic asthma control. Funding: US National Institute of Allergy and Infectious Diseases, US National Institutes of Health.
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U2 - 10.1016/S0140-6736(08)61448-8
DO - 10.1016/S0140-6736(08)61448-8
M3 - Article
C2 - 18805335
AN - SCOPUS:52049108262
SN - 0140-6736
VL - 372
SP - 1065
EP - 1072
JO - The Lancet
JF - The Lancet
IS - 9643
ER -