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: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00495157.
authors.affiliation: Department of Internal Medicine, University of Texas Medical Branch, Galveston, TX 77555, USA. william.calhoun@utmb.edu
authors.forename: William J
authors.initials: WJ
authors.lastname: Calhoun
authors.forename: Bill T
authors.initials: BT
authors.lastname: Ameredes
authors.forename: Tonya S
authors.initials: TS
authors.lastname: King
authors.forename: Nikolina
authors.initials: N
authors.lastname: Icitovic
authors.forename: Eugene R
authors.initials: ER
authors.lastname: Bleecker
authors.forename: Mario
authors.initials: M
authors.lastname: Castro
authors.forename: Reuben M
authors.initials: RM
authors.lastname: Cherniack
authors.forename: Vernon M
authors.initials: VM
authors.lastname: Chinchilli
authors.forename: Timothy
authors.initials: T
authors.lastname: Craig
authors.forename: Loren
authors.initials: L
authors.lastname: Denlinger
authors.forename: Emily A
authors.initials: EA
authors.lastname: DiMango
authors.forename: Linda L
authors.initials: LL
authors.lastname: Engle
authors.forename: John V
authors.initials: JV
authors.lastname: Fahy
authors.forename: J Andrew
authors.initials: JA
authors.lastname: Grant
authors.forename: Elliot
authors.initials: E
authors.lastname: Israel
authors.forename: Nizar
authors.initials: N
authors.lastname: Jarjour
authors.forename: Shamsah D
authors.initials: SD
authors.lastname: Kazani
authors.forename: Monica
authors.initials: M
authors.lastname: Kraft
authors.forename: Susan J
authors.initials: SJ
authors.lastname: Kunselman
authors.forename: Stephen C
authors.initials: SC
authors.lastname: Lazarus
authors.forename: Robert F
authors.initials: RF
authors.lastname: Lemanske
authors.forename: Njira
authors.initials: N
authors.lastname: Lugogo
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Martin
authors.forename: Deborah A
authors.initials: DA
authors.lastname: Meyers
authors.forename: Wendy C
authors.initials: WC
authors.lastname: Moore
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Pascual
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Peters
authors.forename: Joe
authors.initials: J
authors.lastname: Ramsdell
authors.forename: Christine A
authors.initials: CA
authors.lastname: Sorkness
authors.forename: E Rand
authors.initials: ER
authors.lastname: Sutherland
authors.forename: Stanley J
authors.initials: SJ
authors.lastname: Szefler
authors.forename: Stephen I
authors.initials: SI
authors.lastname: Wasserman
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Walter
authors.forename: Michael E
authors.initials: ME
authors.lastname: Wechsler
authors.forename: Homer A
authors.initials: HA
authors.lastname: Boushey
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D001249:Asthma / Q000150:complications / Q000188:drug therapy* / Q000503:physiopathology*; D015415:Biomarkers / Q000032:analysis*; D001944:Breath Tests; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009569:Nitric Oxide / Q000032:analysis; D017410:Practice Guidelines as Topic; D012129:Respiratory Function Tests; D017211:Treatment Failure
chemical_list: D000305:Adrenal Cortex Hormones; D015415:Biomarkers; D009569:Nitric Oxide