Adding Exhaled Nitric Oxide to Guideline-based Asthma Treatment in Inner-City Adolescents and Young Adults: a randomized controlled trial

Background—Preliminary evidence is equivocal regarding the role of exhaled nitric oxide in clinical asthma management. This study evaluates the usefulness of eNO as an adjunct to asthma guidelines-based clinical care among inner-city adolescents and young adults. Corresponding Author: Stanley J. Szefler, MD, Department of Pediatrics, National Jewish Medical and Research Center, 1400 Jackson Street, Room J313, Denver, CO 80206, Tel: 303-398-1193, Fax: 303-270-2189, E-mail: szeflers@njc.org. Request for Reprints: Peter Gergen, M.D., M.P.H., National Institutes of Health, Division of Allergy, Immunology, and Transplantation, 6610 Rockledge Drive, MSC-6601, RM 3067, Bethesda, MD 20892-6601 Publisher's Disclaimer: This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final citable form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain. NIH Public Access Author Manuscript Lancet. Author manuscript; available in PMC 2009 September 20. Published in final edited form as: Lancet. 2008 September 20; 372(9643): 1065–1072. doi:10.1016/S0140-6736(08)61448-8. N IH PA Athor M anscript N IH PA Athor M anscript N IH PA Athor M anscript Methods—A randomized, double-blind, parallel-group trial was conducted with 546 inner-city participants, aged 12–20 years, with persistent asthma (Clinicaltrials.gov Identifier: NCT00114413). A run-in characterization period of 3 weeks on an initial controller regimen preceded a 46-week double-blind treatment strategy. Participants were randomized to either, treatment based on NAEPP guidelines alone (Reference Group) or the guidelines plus FENO measurements (FENO Group). Primary outcome was asthma symptom days and secondary outcome was acute asthma exacerbations. Findings—During the 46-week treatment period, the number of asthma symptom days, pulmonary function, unscheduled care visits, and hospitalizations did not differ between the treatment groups (mean asthma symptom days were 1.93 [95% CI 1.74-2.11] in the FENO group vs. 1.89 [1.71-1.74] in the control group; difference 0.04 [-0.29-0.22], p=0.7796). The FENO Group received a significantly higher inhaled corticosteroid dose (118.9 mcg/day difference, 95% CI: 48.5-189.3, P=0.0010) as compared to the Reference Group. Asthma symptoms remained low in both groups following randomization with 57% (306/534) of the participants well controlled for at least 80% of visits.. Interpretation—A coordinated asthma management program facilitated achieving good control in the majority of participants. The addition of FENO as a control indicator resulted in a higher dose of inhaled corticosteroids without a clinically important improvement in symptomatic asthma control.