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Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-304)

Primary Purpose

Seasonal Allergic Rhinitis (SAR)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GSP 301 NS
GOM-NS
GMM-2 NS
GSP 301 placebo NS
Sponsored by
Glenmark Specialty S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis (SAR)

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Males and non-pregnant females who are 12 years of age and older.
  • Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
  • A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Exclusion Criteria:

  • Pregnant or lactating women.
  • History of anaphylaxis and/or other severe local reaction(s) to skin testing.
  • History of positive test for HIV, Hepatitis B or Hepatitis C infection.
  • Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
  • Subjects with an active pulmonary disorder or infection.
  • Subjects with posterior subcapsular cataracts or glaucoma
  • 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.

Sites / Locations

  • Investigational Site 406
  • Investigational Site 414
  • Investigational Site 435
  • Investigational Site 420
  • Investigational Site 444
  • Investigational Site 428
  • Investigational Site 412
  • Investigational Site 436
  • Investigational Site 432
  • Investigational Site 426
  • Investigational Site 403
  • Investigational Site 443
  • Investigational Site 441
  • Investigational Site 440
  • Investigational Site 405
  • Investigational Site 434
  • Investigational Site 408
  • Investigational Site 418
  • Investigational Site 402
  • Investigational Site 427
  • Investigational Site 419
  • United States 404
  • United States 407
  • Investigational Site 410
  • Investigational Site 424
  • Investigational Site 411
  • Investigational Site 416
  • Investigational Site 415
  • Investigational Site 442
  • Investigational Site 417
  • Investigational Site 421
  • Investigational Site 430
  • Investigational Site 431
  • Investigational Site 433
  • Investigational Site 422
  • Investigational Site 401
  • Investigational Site 413
  • Investigational Site 425
  • Investigational Site 437
  • Investigational Site 400
  • Investigational Site 409
  • Investigational Site 423
  • Investigational Site 439

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

GSP 301 NS

GOM-NS

GMM-2 NS

GSP 301 placebo NS

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
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). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

Secondary Outcome Measures

Full Information

First Posted
August 12, 2016
Last Updated
April 5, 2018
Sponsor
Glenmark Specialty S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02870205
Brief Title
Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)
Acronym
GSP 301-304
Official Title
A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Specialty S.A.

4. Oversight

5. Study Description

Brief Summary
Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis (SAR)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1176 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSP 301 NS
Arm Type
Experimental
Arm Title
GOM-NS
Arm Type
Active Comparator
Arm Title
GMM-2 NS
Arm Type
Active Comparator
Arm Title
GSP 301 placebo NS
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GSP 301 NS
Intervention Description
2 spray in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
GOM-NS
Intervention Description
2 spray in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
GMM-2 NS
Intervention Description
2 spray in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
GSP 301 placebo NS
Intervention Description
2 spray in each nostril twice daily for 14 days
Primary Outcome Measure Information:
Title
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
Description
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). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).
Time Frame
Baseline and day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males and non-pregnant females who are 12 years of age and older. Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen) A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1). Exclusion Criteria: Pregnant or lactating women. History of anaphylaxis and/or other severe local reaction(s) to skin testing. History of positive test for HIV, Hepatitis B or Hepatitis C infection. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. Subjects with an active pulmonary disorder or infection. Subjects with posterior subcapsular cataracts or glaucoma 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudeesh Tantry, PhD
Organizational Affiliation
Glenmark Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 406
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Investigational Site 414
City
Orange
State/Province
California
Country
United States
Facility Name
Investigational Site 435
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigational Site 420
City
Centennial
State/Province
Colorado
Country
United States
Facility Name
Investigational Site 444
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Investigational Site 428
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Investigational Site 412
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigational Site 436
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Investigational Site 432
City
South Dartmouth
State/Province
Massachusetts
Country
United States
Facility Name
Investigational Site 426
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Investigational Site 403
City
Plymouth
State/Province
Minnesota
Country
United States
Facility Name
Investigational Site 443
City
Columbia
State/Province
Missouri
Country
United States
Facility Name
Investigational Site 441
City
Rolla
State/Province
Missouri
Country
United States
Facility Name
Investigational Site 440
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Investigational Site 405
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Investigational Site 434
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Investigational Site 408
City
Rochester
State/Province
New York
Country
United States
Facility Name
Investigational Site 418
City
Rockville Centre
State/Province
New York
Country
United States
Facility Name
Investigational Site 402
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Investigational Site 427
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Investigational Site 419
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
United States 404
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
United States 407
City
Edmond
State/Province
Oklahoma
Country
United States
Facility Name
Investigational Site 410
City
Oklahoma City
State/Province
Oklahoma
Country
United States
Facility Name
Investigational Site 424
City
Tulsa
State/Province
Oklahoma
Country
United States
Facility Name
Investigational Site 411
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site 416
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Investigational Site 415
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 442
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 417
City
Boerne
State/Province
Texas
Country
United States
Facility Name
Investigational Site 421
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Investigational Site 430
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Investigational Site 431
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Investigational Site 433
City
Kerrville
State/Province
Texas
Country
United States
Facility Name
Investigational Site 422
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Investigational Site 401
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 413
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 425
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 437
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 400
City
Waco
State/Province
Texas
Country
United States
Facility Name
Investigational Site 409
City
Waco
State/Province
Texas
Country
United States
Facility Name
Investigational Site 423
City
Draper
State/Province
Utah
Country
United States
Facility Name
Investigational Site 439
City
Greenfield
State/Province
Wisconsin
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30910440
Citation
Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.
Results Reference
derived
Links:
URL
http://epostersonline.com/acaai2017/node/1113
Description
Poster presentation at the "2017 Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology"

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Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

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