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)

NCT03444506 | Completed Phase 2

• 1 other identifier: GPL/CT/2013/001/II
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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®.

Conditions

Seasonal Allergic Rhinitis

Keywords

SAR

Outcome Measures

Primary Outcomes (1)

• 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).

  15 days

Secondary Outcomes (8)

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

  15 days

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

  15 days

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

  15 days

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

  15 days

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

  15 days

Study Arms (5)

Placebo nasal spray

PLACEBO COMPARATOR

Placebo nasal spray - 2 sprays per nostril, BID

Drug: Placebo nasal spray

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

EXPERIMENTAL

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

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

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

EXPERIMENTAL

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

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

DYMISTA nasal spray

ACTIVE COMPARATOR

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

Drug: DYMISTA nasal spray

PATANASE nasal spray

ACTIVE COMPARATOR

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

Drug: PATANASE nasal spray

Interventions

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

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

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

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

Placebo nasal spray DRUG

Placebo nasal spray

DYMISTA nasal spray DRUG

DYMISTA nasal spray

PATANASE nasal spray DRUG

PATANASE nasal spray

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenmark Pharmaceuticals Ltd. India: lead

Study Sites (1)

Glenmark Investigational Site 1

Mississauga, Ontario, L4W 1V7, Canada

Location

Related Publications (1)

• Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):160-166.e1. doi: 10.1016/j.anai.2018.10.011. Epub 2018 Oct 12.

  PMID: 30321655 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sudeesh Tantry, PhD

  Glenmark Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 23, 2018
• Study Start: January 27, 2014
• Primary Completion: February 28, 2014
• Study Completion: February 28, 2014
• Last Updated: June 20, 2018

Record last verified: 2018-06

Locations

CA (1)