Comparison of Physician-, Biomarker-, and Symptom-Based Strategies for Adjustment of Inhaled Corticosteroid Therapy in Adults With Asthma The BASALT Randomized Controlled Trial

被引:153
作者
Calhoun, William J. [1 ]
Ameredes, Bill T. [1 ]
King, Tonya S. [2 ]
Icitovic, Nikolina [2 ]
Bleecker, Eugene R. [3 ]
Castro, Mario [4 ]
Cherniack, Reuben M. [5 ]
Chinchilli, Vernon M. [2 ]
Craig, Timothy [2 ]
Denlinger, Loren [6 ]
DiMango, Emily A. [7 ]
Engle, Linda L. [2 ]
Fahy, John V. [8 ]
Grant, J. Andrew [1 ]
Israel, Elliot [9 ]
Jarjour, Nizar [6 ]
Kazani, Shamsah D. [9 ]
Kraft, Monica [10 ]
Kunselman, Susan J. [2 ]
Lazarus, Stephen C. [8 ]
Lemanske, Robert F., Jr. [6 ]
Lugogo, Njira [10 ]
Martin, Richard J. [5 ]
Meyers, Deborah A. [3 ]
Moore, Wendy C. [3 ]
Pascual, Rodolfo [3 ]
Peters, Stephen P. [3 ]
Ramsdell, Joe [11 ]
Sorkness, Christine A. [6 ]
Sutherland, E. Rand [5 ]
Szefler, Stanley J. [5 ,12 ]
Wasserman, Stephen I. [11 ]
Walter, Michael J. [4 ]
Wechsler, Michael E. [9 ]
Boushey, Homer A. [8 ]
机构
[1] Univ Texas Med Branch, Dept Internal Med, Galveston, TX 77555 USA
[2] Penn State Univ, Dept Publ Hlth Sci, State Coll, PA USA
[3] Wake Forest Univ, Bowman Gray Sch Med, Winston Salem, NC USA
[4] Washington Univ, Dept Med, St Louis, MO USA
[5] Natl Jewish Hlth, Denver, CO USA
[6] Univ Wisconsin Hosp & Clin, Severe Asthma Res Program, Madison, WI 53792 USA
[7] Columbia Univ, Dept Med, New York, NY USA
[8] Univ Calif San Francisco, Dept Med, San Francisco, CA USA
[9] Brigham & Womens Hosp, Boston, MA 02115 USA
[10] Duke Univ, Dept Med, Durham, NC USA
[11] Univ Calif San Diego, Dept Med, San Diego, CA 92103 USA
[12] Univ Colorado, Sch Med, Denver, CO USA
来源
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION | 2012年 / 308卷 / 10期
基金
美国国家卫生研究院;
关键词
EXHALED NITRIC-OXIDE; SPUTUM EOSINOPHIL COUNTS; ETHNIC-DIFFERENCES; HYPERRESPONSIVENESS; ADOLESCENTS; ALBUTEROL; GUIDE;
D O I
10.1001/2012.jama.10893
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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.
引用
收藏
页码:987 / 997
页数:11
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