Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: The BASALT randomized controlled trial

William Calhoun, Bill Ameredes, Tonya S. King, Nikolina Icitovic, Eugene R. Bleecker, Mario Castro, Reuben M. Cherniack, Vernon M. Chinchilli, Timothy Craig, Loren Denlinger, Emily A. DiMango, Linda L. Engle, John V. Fahy, J. Andrew Grant, Elliot Israel, Nizar Jarjour, Shamsah D. Kazani, Monica Kraft, Susan J. Kunselman, Stephen C. LazarusRobert F. Lemanske, Njira Lugogo, Richard J. Martin, Deborah A. Meyers, Wendy C. Moore, Rodolfo Pascual, Stephen P. Peters, Joe Ramsdell, Christine A. Sorkness, E. Rand Sutherland, Stanley J. Szefler, Stephen I. Wasserman, Michael J. Walter, Michael E. Wechsler, Homer A. Boushey

Research output: Contribution to journalArticle

107 Citations (Scopus)

Abstract

Context: No consensus exists for adjusting inhaled corticosteroid therapy in patients with asthma. Approaches include adjustment at outpatient visits guided by physician assessment of asthma control (symptoms, rescue therapy, pulmonary function), based on exhaled nitric oxide, or on a day-to-day basis guided by symptoms. Objective: To determine if adjustment of inhaled corticosteroid therapy based on exhaled nitric oxide or day-to-day symptoms is superior to guideline-informed, physician assessment-based adjustment in preventing treatment failure in adults with mild to moderate asthma. Design, Setting, and Participants: A randomized, parallel, 3-group, placebo-controlled, multiply-blinded trial of 342 adults with mild to moderate asthma controlled by low-dose inhaled corticosteroid therapy (n=114 assigned to physician assessment-based adjustment [101 completed], n=115 to biomarker-based [exhaled nitric oxide] adjustment [92 completed], and n=113 to symptom-based adjustment [97 completed]), the Best Adjustment Strategy for Asthma in the Long Term (BASALT) trial was conducted by the Asthma Clinical Research Network at 10 academic medical centers in the United States for 9 months between June 2007 and July 2010. Interventions: For physician assessment-based adjustment and biomarker-based (exhaled nitric oxide) adjustment, the dose of inhaled corticosteroids was adjusted every 6 weeks; for symptom-based adjustment, inhaled corticosteroids were taken with each albuterol rescue use. Main Outcome Measure: The primary outcome was time to treatment failure. Results: There were no significant differences in time to treatment failure. The 9-month Kaplan-Meier failure rates were 22% (97.5% CI, 14%-33%; 24 events) for physician assessment-based adjustment, 20% (97.5% CI, 13%-30%; 21 events) for biomarker-based adjustment, and 15% (97.5% CI, 9%-25%; 16 events) for symptom-based adjustment. The hazard ratio for physician assessment-based adjustment vs biomarker-based adjustment was 1.2 (97.5% CI, 0.6-2.3). The hazard ratio for physician assessment-based adjustment vs symptom-based adjustment was 1.6 (97.5% CI, 0.8-3.3). Conclusion: Among adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy, the use of either biomarker-based or symptom-based adjustment of inhaled corticosteroids was not superior to physician assessment-based adjustment of inhaled corticosteroids in time to treatment failure. Trial Registration: clinicaltrials.gov Identifier: NCT00495157.

Original languageEnglish
Pages (from-to)987-997
Number of pages11
JournalJAMA - Journal of the American Medical Association
Volume308
Issue number10
DOIs
StatePublished - Sep 5 2012

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Adrenal Cortex Hormones
Asthma
Randomized Controlled Trials
Biomarkers
Physicians
Treatment Failure
Nitric Oxide
Therapeutics
Albuterol
Outpatients
Placebos
Outcome Assessment (Health Care)
Guidelines
Lung
Research

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma : The BASALT randomized controlled trial. / Calhoun, William; Ameredes, Bill; King, Tonya S.; Icitovic, Nikolina; Bleecker, Eugene R.; Castro, Mario; Cherniack, Reuben M.; Chinchilli, Vernon M.; Craig, Timothy; Denlinger, Loren; DiMango, Emily A.; Engle, Linda L.; Fahy, John V.; Grant, J. Andrew; Israel, Elliot; Jarjour, Nizar; Kazani, Shamsah D.; Kraft, Monica; Kunselman, Susan J.; Lazarus, Stephen C.; Lemanske, Robert F.; Lugogo, Njira; Martin, Richard J.; Meyers, Deborah A.; Moore, Wendy C.; Pascual, Rodolfo; Peters, Stephen P.; Ramsdell, Joe; Sorkness, Christine A.; Sutherland, E. Rand; Szefler, Stanley J.; Wasserman, Stephen I.; Walter, Michael J.; Wechsler, Michael E.; Boushey, Homer A.

In: JAMA - Journal of the American Medical Association, Vol. 308, No. 10, 05.09.2012, p. 987-997.

Research output: Contribution to journalArticle

Calhoun, W, Ameredes, B, King, TS, Icitovic, N, Bleecker, ER, Castro, M, Cherniack, RM, Chinchilli, VM, Craig, T, Denlinger, L, DiMango, EA, Engle, LL, Fahy, JV, Grant, JA, Israel, E, Jarjour, N, Kazani, SD, Kraft, M, Kunselman, SJ, Lazarus, SC, Lemanske, RF, Lugogo, N, Martin, RJ, Meyers, DA, Moore, WC, Pascual, R, Peters, SP, Ramsdell, J, Sorkness, CA, Sutherland, ER, Szefler, SJ, Wasserman, SI, Walter, MJ, Wechsler, ME & Boushey, HA 2012, 'Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: The BASALT randomized controlled trial', JAMA - Journal of the American Medical Association, vol. 308, no. 10, pp. 987-997. https://doi.org/10.1001/2012.jama.10893
Calhoun, William ; Ameredes, Bill ; King, Tonya S. ; Icitovic, Nikolina ; Bleecker, Eugene R. ; Castro, Mario ; Cherniack, Reuben M. ; Chinchilli, Vernon M. ; Craig, Timothy ; Denlinger, Loren ; DiMango, Emily A. ; Engle, Linda L. ; Fahy, John V. ; Grant, J. Andrew ; Israel, Elliot ; Jarjour, Nizar ; Kazani, Shamsah D. ; Kraft, Monica ; Kunselman, Susan J. ; Lazarus, Stephen C. ; Lemanske, Robert F. ; Lugogo, Njira ; Martin, Richard J. ; Meyers, Deborah A. ; Moore, Wendy C. ; Pascual, Rodolfo ; Peters, Stephen P. ; Ramsdell, Joe ; Sorkness, Christine A. ; Sutherland, E. Rand ; Szefler, Stanley J. ; Wasserman, Stephen I. ; Walter, Michael J. ; Wechsler, Michael E. ; Boushey, Homer A. / Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma : The BASALT randomized controlled trial. In: JAMA - Journal of the American Medical Association. 2012 ; Vol. 308, No. 10. pp. 987-997.
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title = "Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma: The BASALT randomized controlled trial",
abstract = "Context: No consensus exists for adjusting inhaled corticosteroid therapy in patients with asthma. Approaches include adjustment at outpatient visits guided by physician assessment of asthma control (symptoms, rescue therapy, pulmonary function), based on exhaled nitric oxide, or on a day-to-day basis guided by symptoms. Objective: To determine if adjustment of inhaled corticosteroid therapy based on exhaled nitric oxide or day-to-day symptoms is superior to guideline-informed, physician assessment-based adjustment in preventing treatment failure in adults with mild to moderate asthma. Design, Setting, and Participants: A randomized, parallel, 3-group, placebo-controlled, multiply-blinded trial of 342 adults with mild to moderate asthma controlled by low-dose inhaled corticosteroid therapy (n=114 assigned to physician assessment-based adjustment [101 completed], n=115 to biomarker-based [exhaled nitric oxide] adjustment [92 completed], and n=113 to symptom-based adjustment [97 completed]), the Best Adjustment Strategy for Asthma in the Long Term (BASALT) trial was conducted by the Asthma Clinical Research Network at 10 academic medical centers in the United States for 9 months between June 2007 and July 2010. Interventions: For physician assessment-based adjustment and biomarker-based (exhaled nitric oxide) adjustment, the dose of inhaled corticosteroids was adjusted every 6 weeks; for symptom-based adjustment, inhaled corticosteroids were taken with each albuterol rescue use. Main Outcome Measure: The primary outcome was time to treatment failure. Results: There were no significant differences in time to treatment failure. The 9-month Kaplan-Meier failure rates were 22{\%} (97.5{\%} CI, 14{\%}-33{\%}; 24 events) for physician assessment-based adjustment, 20{\%} (97.5{\%} CI, 13{\%}-30{\%}; 21 events) for biomarker-based adjustment, and 15{\%} (97.5{\%} CI, 9{\%}-25{\%}; 16 events) for symptom-based adjustment. The hazard ratio for physician assessment-based adjustment vs biomarker-based adjustment was 1.2 (97.5{\%} CI, 0.6-2.3). The hazard ratio for physician assessment-based adjustment vs symptom-based adjustment was 1.6 (97.5{\%} CI, 0.8-3.3). Conclusion: Among adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy, the use of either biomarker-based or symptom-based adjustment of inhaled corticosteroids was not superior to physician assessment-based adjustment of inhaled corticosteroids in time to treatment failure. Trial Registration: clinicaltrials.gov Identifier: NCT00495157.",
author = "William Calhoun and Bill Ameredes and King, {Tonya S.} and Nikolina Icitovic and Bleecker, {Eugene R.} and Mario Castro and Cherniack, {Reuben M.} and Chinchilli, {Vernon M.} and Timothy Craig and Loren Denlinger and DiMango, {Emily A.} and Engle, {Linda L.} and Fahy, {John V.} and Grant, {J. Andrew} and Elliot Israel and Nizar Jarjour and Kazani, {Shamsah D.} and Monica Kraft and Kunselman, {Susan J.} and Lazarus, {Stephen C.} and Lemanske, {Robert F.} and Njira Lugogo and Martin, {Richard J.} and Meyers, {Deborah A.} and Moore, {Wendy C.} and Rodolfo Pascual and Peters, {Stephen P.} and Joe Ramsdell and Sorkness, {Christine A.} and Sutherland, {E. Rand} and Szefler, {Stanley J.} and Wasserman, {Stephen I.} and Walter, {Michael J.} and Wechsler, {Michael E.} and Boushey, {Homer A.}",
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TY - JOUR

T1 - Comparison of physician-, biomarker-, and symptom-based strategies for adjustment of inhaled corticosteroid therapy in adults with asthma

T2 - The BASALT randomized controlled trial

AU - Calhoun, William

AU - Ameredes, Bill

AU - King, Tonya S.

AU - Icitovic, Nikolina

AU - Bleecker, Eugene R.

AU - Castro, Mario

AU - Cherniack, Reuben M.

AU - Chinchilli, Vernon M.

AU - Craig, Timothy

AU - Denlinger, Loren

AU - DiMango, Emily A.

AU - Engle, Linda L.

AU - Fahy, John V.

AU - Grant, J. Andrew

AU - Israel, Elliot

AU - Jarjour, Nizar

AU - Kazani, Shamsah D.

AU - Kraft, Monica

AU - Kunselman, Susan J.

AU - Lazarus, Stephen C.

AU - Lemanske, Robert F.

AU - Lugogo, Njira

AU - Martin, Richard J.

AU - Meyers, Deborah A.

AU - Moore, Wendy C.

AU - Pascual, Rodolfo

AU - Peters, Stephen P.

AU - Ramsdell, Joe

AU - Sorkness, Christine A.

AU - Sutherland, E. Rand

AU - Szefler, Stanley J.

AU - Wasserman, Stephen I.

AU - Walter, Michael J.

AU - Wechsler, Michael E.

AU - Boushey, Homer A.

PY - 2012/9/5

Y1 - 2012/9/5

N2 - Context: No consensus exists for adjusting inhaled corticosteroid therapy in patients with asthma. Approaches include adjustment at outpatient visits guided by physician assessment of asthma control (symptoms, rescue therapy, pulmonary function), based on exhaled nitric oxide, or on a day-to-day basis guided by symptoms. Objective: To determine if adjustment of inhaled corticosteroid therapy based on exhaled nitric oxide or day-to-day symptoms is superior to guideline-informed, physician assessment-based adjustment in preventing treatment failure in adults with mild to moderate asthma. Design, Setting, and Participants: A randomized, parallel, 3-group, placebo-controlled, multiply-blinded trial of 342 adults with mild to moderate asthma controlled by low-dose inhaled corticosteroid therapy (n=114 assigned to physician assessment-based adjustment [101 completed], n=115 to biomarker-based [exhaled nitric oxide] adjustment [92 completed], and n=113 to symptom-based adjustment [97 completed]), the Best Adjustment Strategy for Asthma in the Long Term (BASALT) trial was conducted by the Asthma Clinical Research Network at 10 academic medical centers in the United States for 9 months between June 2007 and July 2010. Interventions: For physician assessment-based adjustment and biomarker-based (exhaled nitric oxide) adjustment, the dose of inhaled corticosteroids was adjusted every 6 weeks; for symptom-based adjustment, inhaled corticosteroids were taken with each albuterol rescue use. Main Outcome Measure: The primary outcome was time to treatment failure. Results: There were no significant differences in time to treatment failure. The 9-month Kaplan-Meier failure rates were 22% (97.5% CI, 14%-33%; 24 events) for physician assessment-based adjustment, 20% (97.5% CI, 13%-30%; 21 events) for biomarker-based adjustment, and 15% (97.5% CI, 9%-25%; 16 events) for symptom-based adjustment. The hazard ratio for physician assessment-based adjustment vs biomarker-based adjustment was 1.2 (97.5% CI, 0.6-2.3). The hazard ratio for physician assessment-based adjustment vs symptom-based adjustment was 1.6 (97.5% CI, 0.8-3.3). Conclusion: Among adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy, the use of either biomarker-based or symptom-based adjustment of inhaled corticosteroids was not superior to physician assessment-based adjustment of inhaled corticosteroids in time to treatment failure. Trial Registration: clinicaltrials.gov Identifier: NCT00495157.

AB - Context: No consensus exists for adjusting inhaled corticosteroid therapy in patients with asthma. Approaches include adjustment at outpatient visits guided by physician assessment of asthma control (symptoms, rescue therapy, pulmonary function), based on exhaled nitric oxide, or on a day-to-day basis guided by symptoms. Objective: To determine if adjustment of inhaled corticosteroid therapy based on exhaled nitric oxide or day-to-day symptoms is superior to guideline-informed, physician assessment-based adjustment in preventing treatment failure in adults with mild to moderate asthma. Design, Setting, and Participants: A randomized, parallel, 3-group, placebo-controlled, multiply-blinded trial of 342 adults with mild to moderate asthma controlled by low-dose inhaled corticosteroid therapy (n=114 assigned to physician assessment-based adjustment [101 completed], n=115 to biomarker-based [exhaled nitric oxide] adjustment [92 completed], and n=113 to symptom-based adjustment [97 completed]), the Best Adjustment Strategy for Asthma in the Long Term (BASALT) trial was conducted by the Asthma Clinical Research Network at 10 academic medical centers in the United States for 9 months between June 2007 and July 2010. Interventions: For physician assessment-based adjustment and biomarker-based (exhaled nitric oxide) adjustment, the dose of inhaled corticosteroids was adjusted every 6 weeks; for symptom-based adjustment, inhaled corticosteroids were taken with each albuterol rescue use. Main Outcome Measure: The primary outcome was time to treatment failure. Results: There were no significant differences in time to treatment failure. The 9-month Kaplan-Meier failure rates were 22% (97.5% CI, 14%-33%; 24 events) for physician assessment-based adjustment, 20% (97.5% CI, 13%-30%; 21 events) for biomarker-based adjustment, and 15% (97.5% CI, 9%-25%; 16 events) for symptom-based adjustment. The hazard ratio for physician assessment-based adjustment vs biomarker-based adjustment was 1.2 (97.5% CI, 0.6-2.3). The hazard ratio for physician assessment-based adjustment vs symptom-based adjustment was 1.6 (97.5% CI, 0.8-3.3). Conclusion: Among adults with mild to moderate persistent asthma controlled with low-dose inhaled corticosteroid therapy, the use of either biomarker-based or symptom-based adjustment of inhaled corticosteroids was not superior to physician assessment-based adjustment of inhaled corticosteroids in time to treatment failure. Trial Registration: clinicaltrials.gov Identifier: NCT00495157.

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