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NCT Number: NCT03444506

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)

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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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Glenmark Investigational Site 1

Mississauga, Ontario, L4W 1V7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Drug

Placebo nasal spray

Drug

Dymista Nasal Spray

Drug

PATANASE nasal spray

Drug

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

    Time frame: 15 days

    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).

Secondary outcomes

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

    Time frame: 15 days

    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).

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

    Time frame: 15 days

    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).

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

    Time frame: 15 days

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

    Time frame: 15 days

    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).

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

    Time frame: 15 days

    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).

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

    Time frame: 15 days

    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).

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

    Time frame: 15 days

    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).

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

    Time frame: 15 days

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

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals Ltd. India

Industry

Registry information

Official study title

A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.

Acronym: GSP 301- PoC

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 23, 2018
Registry last updated
Jun 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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