Safety of PATANASE Nasal Spray in Patients With Perennial Allergic Rhinitis

Alcon

Status and phase: Completed; Phase 4

Conditions: Perennial Allergic Rhinitis

Treatments: Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE); Other: Olopatadine nasal spray vehicle, pH 7.0; Other: Olopatadine nasal spray vehicle, pH 3.7

Study type: Interventional

Funder types: Industry

Identifiers

NCT00789555

C-08-32

Details and patient eligibility

About

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).

Enrollment: 1,260 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Sign informed consent;
2. Normal nasal exam;
3. History of perennial allergic rhinitis;
4. Allergy to perennial allergen documented by allergy testing;
5. Age 12 years and older;
6. Must follow instructions;
7. Must make required study visits;
8. Negative pregnancy test and adequate birth control methods for females of childbearing potential;
9. Refrain from certain allergy medications during the study;
10. Other protocol-defined inclusion criteria may apply.

Exclusion criteria

1. Nasal disorders;
2. Use of substances that affect the nasal septum;
3. Exposure to industrial metal plating solutions;
4. Uncontrolled, severe, or unstable diseases;
5. Hypersensitivity to the study drug or nasal spray components;
6. Relative of site staff with access to the protocol;
7. Participation in another investigational study within 30 days or at the same time as this study;
8. Medical Monitor decision;
9. Other protocol-defined exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,260 participants in 3 patient groups, including a placebo group

PATANASE

Experimental group

Description:

Olopatadine hydrochloride 0.6% nasal spray (PATANASE), two sprays in each nostril twice a day (morning and evening) for up to 12 months

Treatment:

Drug: Olopatadine hydrochloride 0.6% nasal spray (PATANASE)

Patanase Vehicle, pH 3.7

Placebo Comparator group

Description:

Olopatadine nasal spray vehicle, pH 3.7, two sprays in each nostril twice a day (morning and evening) for up to 12 months

Treatment:

Other: Olopatadine nasal spray vehicle, pH 3.7

Patanase Vehicle, pH 7.0

Placebo Comparator group

Description:

Olopatadine nasal spray vehicle, pH 7.0, two sprays in each nostril twice a day (morning and evening) for up to 12 months

Treatment:

Other: Olopatadine nasal spray vehicle, pH 7.0