Conditions: Seasonal Allergic Rhinitis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 707
Healthy volunteers: no

Brief summary:
The primary objective of this study is to evaluate the efficacy of the combination of mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) given together once a day in treating subjects with seasonal allergic rhinitis (SAR) in relieving symptoms including nasal congestion. The secondary objectives of this study are to evaluate the potential of the combination to produce tachyphylaxis and/or rebound congestion, and to evaluate the safety of the combination.

Detailed description:

Arms:
arm 1: Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily arm 2: MFNS with OXY 3 sprays once daily arm 3: MFNS once daily arm 4: OXY twice daily arm 5: Placebo nasal spray

Interventions: intervention 1: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) intervention 2: OXY combination: mometasone furoate nasal spray (MFNS) and oxymetazoline nasal spray (OXY) intervention 3: mometasone furoate nasal spray (MFNS) once daily intervention 4: oxymetazoline nasal spray (OXY) twice daily intervention 5: Placebo
Intervention descriptions: intervention 1: MFNS 2 sprays per nostril with OXY 1 spray per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening (PM). intervention 2: MFNS 2 sprays per nostril with OXY 3 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every evening. intervention 3: MFNS 2 sprays per nostril once daily x 2 weeks. Matching placebo to MFNS given every morning (AM) and every evening. intervention 4: OXY 2 sprays per nostril twice daily x 2 weeks. Matching placebo to MFNS given every morning. intervention 5: Matching placebo to MFNS given every morning and every evening x 2 weeks.

Protocol document: