Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial

Stanley J. Szefler, Herman Mitchell, Christine A. Sorkness, Peter J. Gergen, George T. O'Connor, Wayne J Morgan, Meyer Kattan, Jacqueline A. Pongracic, Stephen J. Teach, Gordon R. Bloomberg, Peyton A. Eggleston, Rebecca S. Gruchalla, Carolyn M. Kercsmar, Andrew H. Liu, Jeremy J. Wildfire, Matthew D. Curry, William W. Busse

Research output: Contribution to journalArticle

331 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1065-1072
Number of pages8
JournalThe Lancet
Volume372
Issue number9643
DOIs
StatePublished - 2008

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Young Adult
Nitric Oxide
Asthma
Randomized Controlled Trials
Guidelines
Therapeutics
Adrenal Cortex Hormones
National Institute of Allergy and Infectious Diseases (U.S.)
National Institutes of Health (U.S.)
Biomarkers
Inflammation
Education
Lung
Control Groups

ASJC Scopus subject areas

  • Medicine(all)

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Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults : a randomised controlled trial. / Szefler, Stanley J.; Mitchell, Herman; Sorkness, Christine A.; Gergen, Peter J.; O'Connor, George T.; Morgan, Wayne J; Kattan, Meyer; Pongracic, Jacqueline A.; Teach, Stephen J.; Bloomberg, Gordon R.; Eggleston, Peyton A.; Gruchalla, Rebecca S.; Kercsmar, Carolyn M.; Liu, Andrew H.; Wildfire, Jeremy J.; Curry, Matthew D.; Busse, William W.

In: The Lancet, Vol. 372, No. 9643, 2008, p. 1065-1072.

Research output: Contribution to journalArticle

Szefler, SJ, Mitchell, H, Sorkness, CA, Gergen, PJ, O'Connor, GT, Morgan, WJ, Kattan, M, Pongracic, JA, Teach, SJ, Bloomberg, GR, Eggleston, PA, Gruchalla, RS, Kercsmar, CM, Liu, AH, Wildfire, JJ, Curry, MD & Busse, WW 2008, 'Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial', The Lancet, vol. 372, no. 9643, pp. 1065-1072. https://doi.org/10.1016/S0140-6736(08)61448-8
Szefler, Stanley J. ; Mitchell, Herman ; Sorkness, Christine A. ; Gergen, Peter J. ; O'Connor, George T. ; Morgan, Wayne J ; Kattan, Meyer ; Pongracic, Jacqueline A. ; Teach, Stephen J. ; Bloomberg, Gordon R. ; Eggleston, Peyton A. ; Gruchalla, Rebecca S. ; Kercsmar, Carolyn M. ; Liu, Andrew H. ; Wildfire, Jeremy J. ; Curry, Matthew D. ; Busse, William W. / Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults : a randomised controlled trial. In: The Lancet. 2008 ; Vol. 372, No. 9643. pp. 1065-1072.
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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.

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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.

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