To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

A Double-blind, Randomized, Parallel-group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: GSP 301 Placebo NS; Drug: GSP 301-1 NS (QD); Drug: GSP 301-2 NS (BID); Drug: Olopatadine HCl-1 NS (QD); Drug: Olopatadine HCl-2 NS (BID); Drug: Mometasone Furoate-1 NS (QD); Drug: Mometasone Furoate-2 NS (BID)

• Study Type: Interventional
• Enrollment (Actual): 1111
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States
      • Glenmark Investigational Site 10
    • Austin, Texas, United States
      • Glenmark Investigational Site 5
    • Austin, Texas, United States
      • Glenmark Investigational Site 6
    • Kerrville, Texas, United States
      • Glenmark Investigational Site 2
    • New Braunfels, Texas, United States
      • Glenmark Investigational Site 7
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 3
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 4
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 8
    • San Antonio, Texas, United States
      • Glenmark Investigational Site 9
    • Waco, Texas, United States
      • Glenmark Investigational Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

1. Aged ≥12 years and older inclusive of either sex.
2. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the study season for the mountain cedar pollen
3. A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

Key Exclusion Criteria:

1. Pregnant or lactating women.
2. Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
3. History of nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
4. History of anaphylaxis and/or other severe local reaction(s) to skin testing.
5. History of positive test for HIV, Hepatitis B or Hepatitis C infection.
6. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
7. Subjects with an active pulmonary disorder or infection.
8. Subjects with posterior subcapsular cataracts or glaucoma.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: GSP 301 Placebo NS	Drug: GSP 301 Placebo NS; GSP 301 placebo NS administered as 2 sprays/nostril
Experimental: GSP 301-1 NS (QD)	Drug: GSP 301-1 NS (QD); GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
Experimental: GSP 301-2 NS (BID)	Drug: GSP 301-2 NS (BID); GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
Active Comparator: Olopatadine HCl-1 NS (QD)	Drug: Olopatadine HCl-1 NS (QD); Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Active Comparator: Olopatadine HCl-2 NS (BID)	Drug: Olopatadine HCl-2 NS (BID); Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Active Comparator: Mometasone Furoate-1 NS (QD)	Drug: Mometasone Furoate-1 NS (QD); Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Active Comparator: Mometasone Furoate-2 NS (BID)	Drug: Mometasone Furoate-2 NS (BID); Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in rTNSS From Baseline to End of Treatment	Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows: 0 = absent (no sign/symptom evident); 1 = mild (sign/symptom clearly present, but minimal awareness; easily tolerated); 2 = moderate (definite awareness of sign/symptom that is bothersome but tolerable); 3 = severe (sign/symptom that is hard to tolerate [i.e., causes interference with activities of daily living and/or sleeping])	14 days

Collaborators and Investigators

• Sponsor: Glenmark Pharmaceuticals Ltd. India
• Investigators: Study Director: Sudeesh Tantry, Ph.D, Glenmark Pharmaceuticals Ltd

Publications and helpful links

General Publications

• Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: December 3, 2014
• First Submitted That Met QC Criteria: December 12, 2014
• First Posted (Estimate): December 17, 2014

Study Record Updates

• Last Update Posted (Actual): October 20, 2020
• Last Update Submitted That Met QC Criteria: September 28, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Dermatologic Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Histamine H1 Antagonists, Non-Sedating; Mometasone Furoate; Olopatadine Hydrochloride
• Other Study ID Numbers: GPL/CT/2014/004/II; IND Number: 123164 (Other Identifier: Center for Drug Evaluation and Research (CDER)); Study Number (GSP 301-201) (Other Identifier: Glenmark Pharmaceuticals Ltd.)