title: Clinical Bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with Asthma.
abstract: OT329 SOLIS is a generic candidate for the branded asthma treatment, ADVAIR DISKUS (fluticasone propionate/salmeterol xinafoate), and, as such, the manufacturer is required to provide evidence of clinical "bioequivalence" as a condition for regulatory approval.
  
  
  
  The objective of the current study was to determine if SOLIS and DISKUS provided bioequivalent improvements in lung function at two time points: Day 1 and Week 4.
  
  
  
  This study was a randomized, multiple-dose, placebo-controlled, parallel-group design conducted in the United States (NCT02260492) with a 2-week run-in followed by a 4-week treatment period. Consenting patients were randomized to treatment with OT329 SOLIS 100/50, ADVAIR DISKUS 100/50, or placebo. Lung function was measured predose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours after the first dose to test equivalence of the β-agonist salmeterol component based on FEV1area under the curve (0-12 h). After 4 weeks of twice-daily dosing, trough (predose) FEV1was measured to evaluate equivalence of the fluticasone propionate corticosteroid component. Bioequivalence was concluded if the 90% confidence interval (CI) for the ratio of the products fell within 80-125%.
  
  
  
  Of the 1,524 screened, 879 patients with asthma were randomized to treatment (n = 418 SOLIS, 419 DISKUS, 42 placebo). OT329 SOLIS and ADVAIR DISKUS were bioequivalent at Day 1, with an FEV1area under the curve (0-12 h) test/reference ratio of 108% (90% CI = 94-122%). Likewise, the products were bioequivalent at Week 4 with a trough FEV1test/reference ratio of 105% (90% CI = 90-119). Both active treatments were superior to placebo (P < 0.05) at both time points.
  
  
  
  The data support a conclusion of clinical bioequivalence of OT329 SOLIS to ADVAIR DISKUS. Clinical trial registered with www.clinicaltrials.gov (NCT02260492).
authors.affiliation: Clinical Research Department, Oriel Therapeutics, Berkeley, California.
authors.forename: Malinda V
authors.initials: MV
authors.lastname: Longphre
authors.affiliation: Clinical Research Department, Oriel Therapeutics, Berkeley, California.
authors.forename: Elise Burmeister
authors.initials: EB
authors.lastname: Getz
authors.affiliation: Clinical Research Department, Oriel Therapeutics, Berkeley, California.
authors.forename: Rick
authors.initials: R
authors.lastname: Fuller
mesh_terms: D000280:Administration, Inhalation; D000328:Adult; D019540:Area Under Curve; D001249:Asthma / Q000188:drug therapy*; D001993:Bronchodilator Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D005260:Female; D000068297:Fluticasone-Salmeterol Drug Combination / Q000627:therapeutic use*; D005541:Forced Expiratory Volume / Q000187:drug effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D013810:Therapeutic Equivalency; D016896:Treatment Outcome; D014481:United States
chemical_list: D001993:Bronchodilator Agents; D000068297:Fluticasone-Salmeterol Drug Combination
keywords: FEV1; bioequivalence; fluticasone; generic; salmeterol