NCT04123405

Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis

Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis: a Prospective, Randomized, Double-blind, Placebo-controlled Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 944 (actual)
• Sponsor: Sandoz · Industry
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The trial was conducted as a prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients.

Detailed description

The study was the prospective, randomized, multinational, multicenter, double-blind study in 4 parallel groups of patients. Patients underwent screening examinations at Visit 1. Patients who met all inclusion/ no exclusion criteria were randomized at the baseline visit (Day 1) to the double-blind treatment for a duration of 14 days but in case of delayed final visit (Day 15) the patient could voluntarily take reserve study medication for a maximum of 3 additional days. After the end of the double-blind treatment phase, the patients underwent an end-of-treatment (EOT) examinations on Day 15 (+3). A follow-up phone call within 7 days after Day 15 (or earlier in case of premature termination) was performed.

Conditions

• Rhinosinusitis

Interventions

Type	Name	Description
DRUG	acetylcysteine	600 mg tablet
DRUG	Placebo	Placebo to acetylcysteine

Timeline

• Start date: 2020-10-22
• Primary completion: 2021-04-20
• Completion: 2021-04-20
• First posted: 2019-10-10
• Last updated: 2021-11-19
• Results posted: 2021-11-19

Locations

37 sites across 4 countries: Bulgaria, Germany, Moldova, Russia