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To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Primary Purpose

Seasonal Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
GSP 301-1 NS (QD)
GSP 301-2 NS (BID)
GSP 301 Placebo NS
Olopatadine HCl-1 NS (QD)
Olopatadine HCl-2 NS (BID)
Mometasone Furoate-1 NS (QD)
Mometasone Furoate-2 NS (BID)
Sponsored by
Glenmark Pharmaceuticals Ltd. India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Seasonal Allergic Rhinitis

Eligibility Criteria

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

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.

Sites / Locations

  • Glenmark Investigational Site 10
  • Glenmark Investigational Site 5
  • Glenmark Investigational Site 6
  • Glenmark Investigational Site 2
  • Glenmark Investigational Site 7
  • Glenmark Investigational Site 3
  • Glenmark Investigational Site 4
  • Glenmark Investigational Site 8
  • Glenmark Investigational Site 9
  • Glenmark Investigational Site 1

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Experimental

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

GSP 301 Placebo NS

GSP 301-1 NS (QD)

GSP 301-2 NS (BID)

Olopatadine HCl-1 NS (QD)

Olopatadine HCl-2 NS (BID)

Mometasone Furoate-1 NS (QD)

Mometasone Furoate-2 NS (BID)

Arm Description

Outcomes

Primary Outcome Measures

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])

Secondary Outcome Measures

Full Information

First Posted
December 3, 2014
Last Updated
September 28, 2020
Sponsor
Glenmark Pharmaceuticals Ltd. India
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1. Study Identification

Unique Protocol Identification Number
NCT02318303
Brief Title
To Study GSP 301 in Patients With Seasonal Allergic Rhinitis
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glenmark Pharmaceuticals Ltd. India

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1111 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GSP 301 Placebo NS
Arm Type
Placebo Comparator
Arm Title
GSP 301-1 NS (QD)
Arm Type
Experimental
Arm Title
GSP 301-2 NS (BID)
Arm Type
Experimental
Arm Title
Olopatadine HCl-1 NS (QD)
Arm Type
Active Comparator
Arm Title
Olopatadine HCl-2 NS (BID)
Arm Type
Active Comparator
Arm Title
Mometasone Furoate-1 NS (QD)
Arm Type
Active Comparator
Arm Title
Mometasone Furoate-2 NS (BID)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
GSP 301-1 NS (QD)
Intervention Description
GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
Intervention Type
Drug
Intervention Name(s)
GSP 301-2 NS (BID)
Intervention Description
GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
Intervention Type
Drug
Intervention Name(s)
GSP 301 Placebo NS
Intervention Description
GSP 301 placebo NS administered as 2 sprays/nostril
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCl-1 NS (QD)
Intervention Description
Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Intervention Type
Drug
Intervention Name(s)
Olopatadine HCl-2 NS (BID)
Intervention Description
Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate-1 NS (QD)
Intervention Description
Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate-2 NS (BID)
Intervention Description
Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
Primary Outcome Measure Information:
Title
Change in rTNSS From Baseline to End of Treatment
Description
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])
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key 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 study season for the mountain cedar 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). Key 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 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. 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, Ph.D
Organizational Affiliation
Glenmark Pharmaceuticals Ltd
Official's Role
Study Director
Facility Information:
Facility Name
Glenmark Investigational Site 10
City
Austin
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 5
City
Austin
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 6
City
Austin
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 2
City
Kerrville
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 7
City
New Braunfels
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 3
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 4
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 8
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 9
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Glenmark Investigational Site 1
City
Waco
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
31734334
Citation
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.
Results Reference
derived

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To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

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