Conditions: Sinusitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 237
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Nasonex® (mometasone furoate nasal spray), when used together with an antibiotic, for the relief of symptoms associated with acute bacterial sinusitis. Efficacy will be based on both subjective (assessment of symptom severity by the patient) and objective measurements (computed tomography \[CT\] imaging of the sinuses).

Detailed description:

Arms:
arm 1: Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic. Appropriate antibiotic therapy amoxicillin/clavulanic acid BID. arm 2: Matching placebo nasal spray BID for 29 days, plus amoxicillin/clavulanic acid BID

Interventions: intervention 1: MFNS and antibiotic intervention 2: Matching Placebo nasal spray plus antibiotic
Intervention descriptions: intervention 1: MFNS BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days intervention 2: Matching placebo nasal spray BID for 29 days plus amoxicillin/clavulanic acid BID for 10 days

Protocol document: