Conditions: Perennial Allergic Rhinitis
Keywords: nasal allergy nasal spray seasonal allergy perennial allergy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1260
Healthy volunteers: no

Brief summary:
The purpose of this study was to assess local nasal adverse effects, as well as systemic effects, of PATANASE nasal spray when compared with Patanase Vehicle, pH 3.7 and Patanase Vehicle, pH 7.0 in patients with perennial allergic rhinitis (PAR).

Detailed description:

Arms:
arm 1: Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months arm 2: Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months arm 3: Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months

Interventions: intervention 1: Olopatadine hydrochloride 0.6% nasal spray (PATANASE) intervention 2: Olopatadine nasal spray vehicle, pH 3.7 intervention 3: Olopatadine nasal spray vehicle, pH 7.0
Intervention descriptions: intervention 1: Two sprays in each nostril twice a day (morning and evening) for up to 12 months intervention 2: Two sprays in each nostril twice a day (morning and evening) for up to 12 months intervention 3: Two sprays in each nostril twice a day (morning and evening) for up to 12 months

Protocol document: