METHODS

Design:

randomised controlled trial.

Allocation:

unclear allocation concealment.*

Blinding:

blinded (patients and healthcare providers).*

Follow up period:

up to 29 days.

Setting:

71 medical centres in 14 countries.

Patients:

981 patients ⩾12 years of age (mean age 35 y, 66% women) with signs and symptoms of acute rhinosinusitis for ⩾7 days but ⩽28 days and major symptom score (MSS) ⩾5 but ⩽12, with ⩽3 of 5 symptoms rated as severe (based on the sum of scores for rhinorrhoea, postnasal drip, nasal congestion/stuffiness, sinus headache, and facial pain/pressure/tenderness).

Intervention:

mometasone furoate nasal spray, 200 μg, once daily for 15 days (n  =  243); mometasone spray, 200 μg, twice daily for 15 days (n  =  235); amoxicillin, 500 mg, …