Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-27

Study Completion Date

2014-02-28

Brief Summary

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A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Molo 1 and Molo 2) were evaluated compared to placebo nasal spray, DYMISTA® and PATANASE®.

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo nasal spray

Placebo nasal spray - 2 sprays per nostril, BID

Group Type PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type DRUG

Molo 1 (also referred as GSP 301-2 NS)

Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg nasal spray) - 2 sprays per nostril, BID

Group Type EXPERIMENTAL

Molo 1 (also referred as GSP 301-2 NS)

Intervention Type DRUG

Molo 2 (also referred as GSP 301-1 NS)

Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 50 mcg nasal spray) - 2 sprays per nostril, QD

Group Type EXPERIMENTAL

Molo 2 (also referred as GSP 301-1 NS)

Intervention Type DRUG

DYMISTA nasal spray

Fixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID

Group Type ACTIVE_COMPARATOR

DYMISTA nasal spray

Intervention Type DRUG

PATANASE nasal spray

Olopatadine hydrochloride 665 mcg nasal spray - 2 sprays per nostril, BID

Group Type ACTIVE_COMPARATOR

PATANASE nasal spray

Intervention Type DRUG

Interventions

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Molo 1 (also referred as GSP 301-2 NS)

Intervention Type DRUG

Molo 2 (also referred as GSP 301-1 NS)

Intervention Type DRUG

Placebo nasal spray

Intervention Type DRUG

DYMISTA nasal spray

Intervention Type DRUG

PATANASE nasal spray

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test

Exclusion Criteria

* Pregnant or lactating women
* Patients with known hypersensitivity to any of the components of the formulation
* Patients with a history of seasonal asthma during ragweed season.
* Patient requiring chronic use of inhaled or systemic corticosteroids
* Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening
* Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator.
* Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No