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) (GSP 301- PoC)

Glenmark Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Seasonal Allergic Rhinitis

Treatments: Drug: Placebo nasal spray; Drug: Molo 1 (also referred as GSP 301-2 NS); Drug: DYMISTA nasal spray; Drug: Molo 2 (also referred as GSP 301-1 NS); Drug: PATANASE nasal spray

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444506

GPL/CT/2013/001/II

Details and patient eligibility

About

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®.

Enrollment: 180 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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180 participants in 5 patient groups, including a placebo group

Placebo nasal spray

Placebo Comparator group

Description:

Placebo nasal spray - 2 sprays per nostril, BID

Treatment:

Drug: Placebo nasal spray

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

Experimental group

Description:

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

Treatment:

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

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

Experimental group

Description:

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

Treatment:

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

DYMISTA nasal spray

Active Comparator group

Description:

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

Treatment:

Drug: DYMISTA nasal spray

PATANASE nasal spray

Active Comparator group

Description:

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

Treatment:

Drug: PATANASE nasal spray