title: Clinically relevant effect of a new intranasal therapy (MP29-02) in allergic rhinitis assessed by responder analysis.
abstract: BACKGROUND
  It is unclear what constitutes a clinically meaningful response for allergic rhinitis (AR) outcomes. The objectives of these post hoc analyses were (1) to define a clinically meaningful response using novel efficacy analyses (including a responder analysis), and (2) to compare the efficacy of MP29-02 [a novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP)] with commercially available FP, AZE and placebo in seasonal AR (SAR) patients, using these novel analyses.
  
  
  METHODS
  610 moderate-to-severe SAR patients (≥12 years old) were randomized into a double-blind, placebo-controlled, 14-day, parallel-group trial. Change from baseline in the reflective total nasal symptom score (rTNSS) over 14 days was the primary outcome. Post hoc endpoints included the sum of nasal and ocular symptoms (rT7SS), efficacy by disease severity and by predominant nasal symptom, and a set of responder analyses.
  
  
  RESULTS
  MP29-02 most effectively reduced rT7SS (relative greater improvement: 52% to FP; 56% to AZE) and both nasal and ocular symptoms irrespective of severity. More MP29-02 patients achieved a ≥30, ≥50, ≥60, ≥75 and ≥90% rTNSS reduction, which occurred days faster than with either active comparator; MP29-02 alone was superior to placebo at the ≥60% (or higher) threshold. One in 2 MP29-02 patients achieved a ≥50% rTNSS reduction and 1 in 6 achieved complete/near-to-complete response. Only MP29-02 was consistently superior to placebo for all patients, whatever their predominant symptom.
  
  
  CONCLUSIONS
  MP29-02 provided faster and more complete symptom control than first-line therapies. It was consistently superior irrespective of severity, response criteria or patient-type, and may be considered the drug of choice for moderate-to-severe AR. These measures define a new standard for assessing relevance in AR.
authors: Allergy and Asthma Medical Group and Research Center, San Diego, CA, USA.
authors: Eli
authors: E
authors: Meltzer
authors: Paul
authors: P
authors: Ratner
authors: Claus
authors: C
authors: Bachert
authors: Warner
authors: W
authors: Carr
authors: William
authors: W
authors: Berger
authors: G Walter
authors: GW
authors: Canonica
authors: James
authors: J
authors: Hadley
authors: Phil
authors: P
authors: Lieberman
authors: Frank C
authors: FC
authors: Hampel
authors: Joaquim
authors: J
authors: Mullol
authors: Ullrich
authors: U
authors: Munzel
authors: David
authors: D
authors: Price
authors: Glenis
authors: G
authors: Scadding
authors: J Christian
authors: JC
authors: Virchow
authors: Ulrich
authors: U
authors: Wahn
authors: Ruth
authors: R
authors: Murray
authors: Jean
authors: J
authors: Bousquet
mesh_terms: D000328:Adult; D000730:Androstadienes / Q000008:administration & dosage*; D018926:Anti-Allergic Agents / Q000008:administration & dosage*; D028203:Cedrus / Q000276:immunology; D018450:Disease Progression; D004338:Drug Combinations; D005260:Female; D000068298:Fluticasone; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D015508:Nasal Obstruction / Q000209:etiology / Q000517:prevention & control*; D010793:Phthalazines / Q000008:administration & dosage*; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications / Q000188:drug therapy* / Q000276:immunology; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000730:Androstadienes; D018926:Anti-Allergic Agents; D004338:Drug Combinations; C573864:MP29-02; D010793:Phthalazines; D000068298:Fluticasone; C020976:azelastine