Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) (GSP 301-305)

A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Study Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis (SAR)
• Intervention / Treatment: Drug: GSP 301 NS; Drug: GSP 301 Placebo NS

• Study Type: Interventional
• Enrollment (Actual): 446
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Mission Viejo, California, United States, 19406
      • Glenmark Investigational Site 18
    • Ontario, California, United States, 910762
      • Glenmark Investigational Site 32
    • Paramount, California, United States, 90723
      • Glenmark Investigational Site 30
    • San Diego, California, United States, 92108
      • Glenmark Investigational Site 17
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Glenmark Investigational Site 21
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Glenmark Investigational Site 13
    • Savannah, Georgia, United States, 31312
      • Glenmark Investigational Site 26
  • Kentucky
    • Louisville, Kentucky, United States, 40215
      • Glenmark Investigational Site 28
  • Maryland
    • Baltimore, Maryland, United States, 21236-5992
      • Glenmark Investigational Site 14
    • Bethesda, Maryland, United States, 20814-2672
      • Glenmark Investigational Site 19
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Glenmark Investigational Site 25
  • Missouri
    • Columbia, Missouri, United States, 65203
      • Glenmark Investigational Site 12
    • Rolla, Missouri, United States, 65401
      • Glenmark Investigational Site 10
    • Warrensburg, Missouri, United States, 64093
      • Glenmark Investigational Site 27
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Glenmark Investigational Site 15
  • North Carolina
    • High Point, North Carolina, United States, 27262-4320
      • Glenmark Investigational Site 3
    • Raleigh, North Carolina, United States, 27607
      • Glenmark Investigational Site 8
  • Ohio
    • Cincinnati, Ohio, United States, 45231
      • Glenmark Investigational Site 11
    • Cincinnati, Ohio, United States, 45242
      • Glenmark Investigational Site 29
  • Oklahoma
    • Edmond, Oklahoma, United States, 73034
      • Glenmark Investigational Site 2
    • Tulsa, Oklahoma, United States, 74136
      • Glenmark Investigational Site 33
  • Oregon
    • Medford, Oregon, United States, 97504-9741
      • Glenmark Investigational Site 4
  • South Carolina
    • Spartanburg, South Carolina, United States, 29303
      • Glenmark Investigational Site 6
  • Texas
    • Austin, Texas, United States, 78759
      • Glenmark Investigational Site 5
    • Kerrville, Texas, United States, 78028-6071
      • Glenmark Investigational Site 24
    • New Braunfels, Texas, United States, 78130
      • Glenmark Investigational Site 1
    • San Antonio, Texas, United States, 78229-3749
      • Glenmark Investigational Site 7
    • San Antonio, Texas, United States, 78229
      • Glenmark Investigational Site 9
    • Waco, Texas, United States, 76712
      • Glenmark Investigational Site 20
    • Waco, Texas, United States, 76712
      • Glenmark Investigational Site 31
  • Utah
    • Draper, Utah, United States, 84020
      • Glenmark Investigational Site 22
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53288
      • Glenmark Investigational Site 23

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male and female subjects aged ≥6 to <12 years
2. Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
3. Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
4. A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
5. Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Exclusion Criteria:

1. Females of childbearing potential or pregnant
2. Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
3. History of anaphylaxis and/or other severe local reaction(s) to skin testing
4. History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
5. Subjects with an active pulmonary disorder or infection.
6. 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: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GSP 301 NS; Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS	Drug: GSP 301 NS; 1 spray in each nostril twice daily for 14 days
Placebo Comparator: GSP 301 Placebo NS; GSP 301 Placebo nasal spray	Drug: GSP 301 Placebo NS; 1 spray in each nostril twice daily for 14 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period	The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.	Baseline and day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.	The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous (ie, an evaluation of the symptom severity just before taking study medication [within 10 minutes]) of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the iTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the iTNSS is summed. The total score of the iTNSS ranged from 0 to 12.	Baseline and day 14
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)	The PRQLQ is a validated, disease-specific, quality-of-life (QOL) questionnaire developed to measure the physical, emotional, and social impairments that are experienced by children (aged ≥6 to <12 years) with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation and other symptoms). Subjects recall how they have been during the previous week and respond to each question on a 7-point scale with scores ranging from 6 (extremely bothered), 5 (very bothered), 4 (quite bothered), 3 (somewhat bothered), 2 (bothered a bit), 1 (hardly bothered at all), 0 (not bothered). The Overall PRQLQ score is the mean of all 23 subject-reported responses. The Overall PRQLQ score range from 0 to 6 where 0 represents no impairment and 6 represents maximum impairment.	Baseline and day 15
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.	The Total Ocular Symptom Score (TOSS) will be calculated using the 3 eye-related non-nasal symptoms: itching/burning eyes, tearing/watering eyes, and redness of eyes. The subject will assess and report his/her non-nasal symptoms twice (AM and PM assessments). Scores ranged from 0 (No sign/symptom evident), 1 (Sign/symptom clearly present but minimal awareness; easily tolerated), 2 (Definite awareness of sign/symptom that is bothersome but tolerable) and 3 (Sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The Total Ocular Symptom Score (TOSS) ranged from 0 to 9.	Baseline and day 14

Collaborators and Investigators

• Sponsor: Glenmark Specialty S.A.
• Investigators: Study Director: Sudeesh Tantry, PhD, Glenmark Pharmaceuticals Ltd.

Publications and helpful links

General Publications

• Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022 Nov;129(5):618-626.e2. doi: 10.1016/j.anai.2022.07.029. Epub 2022 Aug 1.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2018
• Primary Completion (Actual): November 14, 2018
• Study Completion (Actual): November 14, 2018

Study Registration Dates

• First Submitted: March 5, 2018
• First Submitted That Met QC Criteria: March 9, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2019
• Last Update Submitted That Met QC Criteria: September 19, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis
• 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
• Other Study ID Numbers: GSP 301-305

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No