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)

Glenmark Pharmaceuticals Ltd. India180 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

180

Conditions

Seasonal Allergic Rhinitis

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment

Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).

Time frame: 15 days

Secondary Outcomes

Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase

Time frame: 15 days

Change in mean post-treatment iTNSS for reference products Dymista and Patanase compared with placebo

Time frame: 15 days

Onset of action assessed by comparing change in iTNSS after the first dose

Time frame: 15 days

Change from baseline in post-treatment instantaneous Total Symptoms Score (iTSS) (Molo 1 and Molo 2 versus Active Comparator)

Instantaneous Total Symptom Score (iTSS) is calculated as the sum of the four individual nasal symptom (nasal congestion, rhinorrhea, nasal itching, sneezing) scores and the three individual ocular symptom (ocular itching, tearing/watering eyes, and ocular redness) scores. Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).

Time frame: 15 days

Change from baseline in individual instantaneous Nasal Symptoms Scores (iNSS) (Molo 1 and Molo 2 versus Active Comparator)

Individual Instantaneous Nasal Symptoms Scores (iNSS) is calculated as the score of individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).

Time frame: 15 days

Change from baseline in instantaneous Total Ocular Symptom Score (iTOSS) (Molo 1 and Molo 2 versus Active Comparator)

Instantaneous Total Ocular Symptom Score (iTOSS) is calculated as the sum of the three individual ocular symptoms (ocular itching, tearing/watering eyes, and ocular redness). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).

Time frame: 15 days

Change in mean post-treatment Environmental Exposure Chamber - Rhinoconjunctivitis Quality-of-Life Questionnaire (EEC-QoLQ) scores

The EEC-QoLQ has questions in three domains (non-nose/eye symptoms, practical problems and emotional) related to how much a subject was bothered with symptoms. Subject responds on a 7-point scale with score ranging from 0 (better outcome) to 6 (worse outcome).

Time frame: 15 days

Responses to a reflective Global Assessment of Tolerability and Acceptance Questionnaire (GATAQ)

Scale of 0 (very much acceptable) - 6 (not acceptable)

Time frame: 15 days

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)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes