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Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR) (GSP 301-303)

Primary Purpose

Perennial Allergic Rhinitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GSP 301 NS
GSP 301 Placebo NS pH 3.7
GSP 301 Placebo NS pH 7.0
Sponsored by
Glenmark Specialty S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perennial 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 PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.

Exclusion Criteria:

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Placebo Comparator

Arm Label

GSP 301 NS

GSP 301 Placebo NS pH 3.7

GSP 301 Placebo NS pH 7.0

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants With Treatment-emergent Adverse Events (TEAEs).
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.

Secondary Outcome Measures

Full Information

First Posted
March 11, 2016
Last Updated
February 12, 2020
Sponsor
Glenmark Specialty S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02709538
Brief Title
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
Acronym
GSP 301-303
Official Title
A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 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
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial 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
Perennial Allergic Rhinitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GSP 301 NS
Arm Type
Experimental
Arm Title
GSP 301 Placebo NS pH 3.7
Arm Type
Placebo Comparator
Arm Title
GSP 301 Placebo NS pH 7.0
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
GSP 301 NS
Intervention Description
FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
GSP 301 Placebo NS pH 3.7
Intervention Description
2 spray in each nostril twice daily for 52 weeks
Intervention Type
Drug
Intervention Name(s)
GSP 301 Placebo NS pH 7.0
Intervention Description
2 spray in each nostril twice daily for 52 weeks
Primary Outcome Measure Information:
Title
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
Description
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Time Frame
52 weeks

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 PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sudeesh Tantry
Organizational Affiliation
Glenmark Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site 2
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Investigational Site 28
City
Encinitas
State/Province
California
Country
United States
Facility Name
Investigational Site 27
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigational Site 29
City
San Diego
State/Province
California
Country
United States
Facility Name
Investigational Site 32
City
Denver
State/Province
Colorado
Country
United States
Facility Name
Investigational Site 26
City
Aventura
State/Province
Florida
Country
United States
Facility Name
Investigational Site 9
City
Miami
State/Province
Florida
Country
United States
Facility Name
Investigational Site 33
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Investigational Site 11
City
Stockbridge
State/Province
Georgia
Country
United States
Facility Name
Investigational Site 4
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Investigational Site 5
City
Bethesda
State/Province
Maryland
Country
United States
Facility Name
Investigational Site 15
City
Saint Louis
State/Province
Missouri
Country
United States
Facility Name
Investigational Site 30
City
Bellevue
State/Province
Nebraska
Country
United States
Facility Name
Investigational Site 19
City
Skillman
State/Province
New Jersey
Country
United States
Facility Name
Investigational Site 18
City
Corning
State/Province
New York
Country
United States
Facility Name
Investigational Site 7
City
High Point
State/Province
North Carolina
Country
United States
Facility Name
Investigational Site 21
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Investigational Site 16
City
Sylvania
State/Province
Ohio
Country
United States
Facility Name
Investigational Site 22
City
Pittsburgh
State/Province
Pennsylvania
Country
United States
Facility Name
Investigational Site 13
City
Spartanburg
State/Province
South Carolina
Country
United States
Facility Name
Investigational Site 23
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 24
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 3
City
Austin
State/Province
Texas
Country
United States
Facility Name
Investigational Site 31
City
Dallas
State/Province
Texas
Country
United States
Facility Name
Investigational Site 34
City
El Paso
State/Province
Texas
Country
United States
Facility Name
Investigational Site 6
City
Kerrville
State/Province
Texas
Country
United States
Facility Name
Investigational Site 14
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Investigational Site 10
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 12
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 17
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 1
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 20
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Investigational Site 25
City
Waco
State/Province
Texas
Country
United States
Facility Name
Investigational Site 8
City
Waco
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31248471
Citation
Segall N, Prenner B, Lumry W, Caracta CF, Tantry SK. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019 Sep 1;40(5):301-310. doi: 10.2500/aap.2019.40.4233. Epub 2019 Jun 27.
Results Reference
derived

Learn more about this trial

Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

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