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Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR) (GSP 301-301)

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GSP 301 NS
Olopatadine HCl NS
Mometasone furoate 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 focused on measuring Seasonal Allergic Rhinitis

Eligibility Criteria

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

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 spring allergy season (tree/grass 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).

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

Sites / Locations

  • Investigational Site 20
  • Investigational Site 31
  • Investigational Site 29
  • Investigational Site 25
  • Investigational Site 22
  • Investigational Site 10
  • Investigational Site 30
  • Investigational Site 37
  • Investigational Site 15
  • Investigational Site 23
  • Investigational Site 11
  • Investigational Site 14
  • Investigational Site 33
  • Investigational Site 26
  • Investigational Site 19
  • Investigational Site 21
  • Investigational Site 16
  • Investigational Site 12
  • Investigational Site 36
  • Investigational Site 18
  • Investigational Site 27
  • Investigational Site 34
  • Investigational Site 32
  • Investigational Site 35
  • Investigational Site 13
  • Investigational Site 17
  • Investigational Site 3
  • Investigational Site 5
  • Investigational Site 8
  • Investigational Site 1
  • Investigational Site 7
  • Investigational Site 2
  • Investigational Site 4
  • Investigational Site 6
  • Investigational Site 9
  • Investigational Site 28
  • Investigational Site 24

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

Olopatadine HCl NS

Mometasone furoate NS

GSP 301 Placebo NS

Arm Description

Outcomes

Primary Outcome Measures

Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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
December 10, 2015
Last Updated
August 28, 2018
Sponsor
Glenmark Specialty S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02631551
Brief Title
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Acronym
GSP 301-301
Official Title
A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (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 and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1180 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSP 301 NS
Arm Type
Experimental
Arm Title
Olopatadine HCl NS
Arm Type
Active Comparator
Arm Title
Mometasone furoate 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
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCl NS
Intervention Description
2 sprays in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate NS
Intervention Description
2 sprays in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
GSP 301 Placebo NS
Intervention Description
2 sprays in each nostril twice daily for 14 days
Primary Outcome Measure Information:
Title
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Description
Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged 12 years and older inclusive of either sex. 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 spring allergy season (tree/grass pollen) 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). Exclusion Criteria: Pregnant or lactating women. Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudeesh Tantry, PhD
Organizational Affiliation
Glenmark Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 20
City
Mission Viejo
State/Province
California
Country
United States
Facility Name
Investigational Site 31
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigational Site 29
City
San Jose
State/Province
California
Country
United States
Facility Name
Investigational Site 25
City
Centennial
State/Province
Colorado
Country
United States
Facility Name
Investigational Site 22
City
Colorado Springs
State/Province
Colorado
Country
United States
Facility Name
Investigational Site 10
City
Jupiter
State/Province
Florida
Country
United States
Facility Name
Investigational Site 30
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigational Site 37
City
Marietta
State/Province
Georgia
Country
United States
Facility Name
Investigational Site 15
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Investigational Site 23
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Investigational Site 11
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Investigational Site 14
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
Investigational Site 33
City
Wheaton
State/Province
Maryland
Country
United States
Facility Name
Investigational Site 26
City
Ypsilanti
State/Province
Michigan
Country
United States
Facility Name
Investigational Site 19
City
Minneapolis
State/Province
Minnesota
Country
United States
Facility Name
Investigational Site 21
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Investigational Site 16
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Investigational Site 12
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Investigational Site 36
City
Rochester
State/Province
New York
Country
United States
Facility Name
Investigational Site 18
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Investigational Site 27
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Investigational Site 34
City
Middleburg Heights
State/Province
Ohio
Country
United States
Facility Name
Investigational Site 32
City
Medford
State/Province
Oregon
Country
United States
Facility Name
Investigational Site 35
City
Portland
State/Province
Oregon
Country
United States
Facility Name
Investigational Site 13
City
Orangeburg
State/Province
South Carolina
Country
United States
Facility Name
Investigational Site 17
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Investigational Site 3
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 5
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 8
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1
City
Kerrville
State/Province
Texas
Country
United States
Facility Name
Investigational Site 7
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Investigational Site 2
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 4
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 6
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 9
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 28
City
Waco
State/Province
Texas
Country
United States
Facility Name
Investigational Site 24
City
Draper
State/Province
Utah
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31053180
Citation
Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3.
Results Reference
derived

Learn more about this trial

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

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