title: Efficacy and Safety of an Oral Ambroxol Spray in the Treatment of Acute Uncomplicated Sore Throat.
abstract: OBJECTIVE
  Compare the efficacy and tolerability of oral spray formulations delivering 2.5, 5, and 10 mg ambroxol (AXS) per application (4 actuations/application) in relieving acute sore throat vs. spraying a matched placebo solution.
  
  
  METHODS
  Multi-centre, placebo-controlled, randomised, double-blind trial with up to 6 daily applications of the assigned medication for up to 3 days.
  
  
  METHODS
  511 outpatients with acute sore throat were enrolled, 494 were treated.
  
  
  METHODS
  Up to 6 spray applications per day as needed for up to 3 days.
  
  
  RESULTS
  All treatments led to a reduction in pain intensity (PI); the mean cumulative PI-reductions over the first 2 h after the 1(st) dose (SPIDnorm(0-2)) were 24.7, 26.6, 26.0, and 32.2% (SEM: 0.023) of the predose PI for treatment with placebo, and the 2.5, 5, and 10 mg AXS, respectively. These mean reductions were 2 (CI: -3.6; 7.5), 1.3 (CI: -4.3; 6.8), and 7.5 (CI: 2.0;13.1) percent points larger than for placebo. The 2.5 and 5 mg AXS were not distinguishable from placebo, but the 10 mg AXS was evidently superior. The numbers needed to treat (NNT) when comparing 10 mg AXS with placebo, were 9.5 and 8.8 for an average pain relief of 33 and 50% of the maximum achievable effect over the first 2 h.
  
  
  CONCLUSIONS
  10 mg AXS showed a statistically significantly superior pain reduction relative to the placebo spray. Treatment with 10 mg AXS reaches an extent of pain relief that can be accepted to be clinically meaningful and was well tolerated.
authors.affiliation: ACPS - Applied Clinical Pharmacology Services, Mainz-Kastel, Germany.
authors.forename: C
authors.initials: C
authors.lastname: de Mey
authors.affiliation: Boehringer Ingelheim (Pty) Ltd, Randburg, South Africa.
authors.forename: J
authors.initials: J
authors.lastname: Patel
authors.affiliation: 1644 Starling Street, Lenasia South, Johannesburg, South Africa.
authors.forename: D R
authors.initials: DR
authors.lastname: Lakha
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
authors.forename: E
authors.initials: E
authors.lastname: Richter
authors.affiliation: Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim am Rhein, Germany.
authors.forename: S
authors.initials: S
authors.lastname: Koelsch
mesh_terms: D000208:Acute Disease; D000328:Adult; D000551:Ambroxol / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005100:Expectorants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008297:Male; D061366:Numbers Needed To Treat; D058993:Oral Sprays; D010146:Pain / Q000150:complications* / Q000188:drug therapy*; D010612:Pharyngitis / Q000150:complications* / Q000188:drug therapy*; D055815:Young Adult
chemical_list: D005100:Expectorants; D058993:Oral Sprays; D000551:Ambroxol