A prospective, controlled, randomized, double blind, 2-arms, parallel-group, multicentre, phase 3 study to investigate effectiveness of Actisoufre nasal spray in a pressurized container compared to placebo in female and male adult and paediatric population over 6 years old with acute rhinitis, rhinopharyngitis and rhinosinusitis not requiring antibiotic therapy.

Condition studied

rhinosinusitis not requiring antibiotic therapy, rhinopharyngitis not requiring antibiotic therapy, Acute rhinitis not requiring antibiotic therapy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change of the nasal symptoms (nasal obstruction, rhinorrhea (drip, sniff, snorting, drainage, discharge), thick mucus, sneezing, cough evaluated from baseline at Day 4 based on the specific “Common Cold Symptoms Severity Questionnaire” (CCSS), in the intervention group and in the control group. [Time points of CCSS assessment: Baseline (Day 1), Day 2, Day 3, Day 4, Day 8]

Endpoint detail

Change in the quality of sleep in the Actisoufre arm comparing to the placebo. [Time point: Baseline (Day 1), Day 2, Day 3, Day 4, Day 8], Change in patient’s Quality of Life based on the VAS scale [Time point: Baseline (Day 1), Day 4, Day 8], Evaluation of onset of immediate relief after the entire product application is completed at Day 1 (baseline) and once daily up to Day 4 of the study. [Time point: Baseline, Day 2, Day 3, Day 4], Number of subjects with a need of use of nasal decongestants as an emergency treatment. [Time point: Day 8], Assessment of use of concomitant medications (including frequency) from baseline to the end of the study. [Time point: Baseline, Day 4, Day 8], Number of Adverse Events and Serious Adverse Events in intervention group comparing to the control group. [Time point: Baseline, Day 4, Day 8]