Efficacy and safety of acetylcysteine for the treatment of acute uncomplicated rhinosinusitis: a prospective, randomized, double-blind, placebo-controlled trial

INTERVENTION: Trade Name: A?? 600 MG ????????????? ???????? Product Name: Acetylcysteine 600 mg effervescent tablet Product Code: ACC 600 Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616‐91‐1 Current Sponsor code: ACC 600 Other descriptive name: ACC 600 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600‐ Pharmaceutical form of the placebo: Effervescent tablet Route of administration of the placebo: Oral use CONDITION: Acute rhinosinusitis ; MedDRA version: 20.0 Level: LLT Classification code 10052106 Term: Rhinosinusitis System Organ Class: 100000004862 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: Main Objective: The primary objective of the present trial is the assessment of the efficacy of three different total daily doses of the investigational product containing 600 mg acetylcysteine per effervescent tablet compared to placebo for the treatment of acute uncomplicated rhinosinusitis. Primary end point(s): Mean change from baseline in the daily MSS over the entire treatment period. Secondary Objective: The secondary objective of the present trial is the assessment of safety and tolerability of three different total daily doses of the investigational product containing 600 mg acetylcysteine per effervescent tablet compared to placebo for the treatment of acute uncomplicated rhinosinusitis. Timepoint(s) of evaluation of this end point: After the end of the clinical part of the trial, following database lock and unblinding. SECONDARY OUTCOME: Secondary end point(s): Secondary endpoints are: ; Time to onset of action defined as first day of active treatment on which MSS shows statistically significant difference from placebo; ; MSS (major symptom score) development over the course of the study; ; SNOT‐22 (sino‐nasal outcome test) by visit and changes versus baseline; ; Percentage of responders and non‐responders to treatment based on the assessment of overall response to treatment by the investigator. ; ; The safety endpoints are: ; • Incidence and severity of adverse events ; • Incidence and severity of drug‐related adverse events ; • Clinically relevant changes in laboratory parameters, vital signs, physical and ENT examination parameters from Visit 1 to Visit 6 (or early termination) ; • Overall assessment of tolerability by patient and by investigator. Timepoint(s) of evaluation of this end point: After the end of the clinical part of the trial, following database lock and unblinding. INCLUSION CRITERIA: [1] Male or female subjects aged between 14 and 75 years inclusive on the date of consent [2] Diagnosis of acute, uncomplicated rhinosinusitis defined at screening Visit 1 and at Visit 2 as: a) major symptom score (MSS) assessed by the patient =8 and =12 points for the following: rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure, whereupon the nasal congestion is mandatory and no more than 3 of the 5 symptoms are rated as severe b) individual score for facial pain/pressure =1 (mild) and =2 (moderate) c) presence of symptoms =3 days prior to screening visit [3] For adults (=18 years): Informed consent to participate in the trial provided in written form; For adolescents (=14 ‐ <18 years): own subject informed consent/ assent to participate in the trial and the informed consent from all parent(s)/ legal guardian(s) provided in written form. Are the trial subjects under 18? yes N