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

Primary Purpose

Seasonal Allergic Rhinitis (SAR)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
GSP 301 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) focused on measuring GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

GSP 301 NS

GSP 301 Placebo NS

Arm Description

Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS

GSP 301 Placebo nasal spray

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
March 5, 2018
Last Updated
September 19, 2019
Sponsor
Glenmark Specialty S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03463031
Brief Title
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Acronym
GSP 301-305
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
March 16, 2018 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
November 14, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis (SAR)
Keywords
GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
GSP 301 NS
Arm Type
Experimental
Arm Description
Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
Arm Title
GSP 301 Placebo NS
Arm Type
Placebo Comparator
Arm Description
GSP 301 Placebo nasal spray
Intervention Type
Drug
Intervention Name(s)
GSP 301 NS
Intervention Description
1 spray in each nostril twice daily for 14 days
Intervention Type
Drug
Intervention Name(s)
GSP 301 Placebo NS
Intervention Description
1 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) Over the 14-day Treatment Period
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). 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.
Time Frame
Baseline and day 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.
Description
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.
Time Frame
Baseline and day 14
Title
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)
Description
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.
Time Frame
Baseline and day 15
Title
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.
Description
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.
Time Frame
Baseline and day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged ≥6 to <12 years Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen) Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening Signed informed consent/assent form (subject and parent/caregiver/legal guardian) Exclusion Criteria: Females of childbearing potential or pregnant 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. History of anaphylaxis and/or other severe local reaction(s) to skin testing History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal 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 Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Glenmark Investigational Site 18
City
Mission Viejo
State/Province
California
ZIP/Postal Code
19406
Country
United States
Facility Name
Glenmark Investigational Site 32
City
Ontario
State/Province
California
ZIP/Postal Code
910762
Country
United States
Facility Name
Glenmark Investigational Site 30
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
Glenmark Investigational Site 17
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Glenmark Investigational Site 21
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Glenmark Investigational Site 13
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Glenmark Investigational Site 26
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31312
Country
United States
Facility Name
Glenmark Investigational Site 28
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40215
Country
United States
Facility Name
Glenmark Investigational Site 14
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236-5992
Country
United States
Facility Name
Glenmark Investigational Site 19
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814-2672
Country
United States
Facility Name
Glenmark Investigational Site 25
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Glenmark Investigational Site 12
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
Glenmark Investigational Site 10
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Glenmark Investigational Site 27
City
Warrensburg
State/Province
Missouri
ZIP/Postal Code
64093
Country
United States
Facility Name
Glenmark Investigational Site 15
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Glenmark Investigational Site 3
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262-4320
Country
United States
Facility Name
Glenmark Investigational Site 8
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Glenmark Investigational Site 11
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Glenmark Investigational Site 29
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Glenmark Investigational Site 2
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73034
Country
United States
Facility Name
Glenmark Investigational Site 33
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Glenmark Investigational Site 4
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504-9741
Country
United States
Facility Name
Glenmark Investigational Site 6
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Glenmark Investigational Site 5
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
Glenmark Investigational Site 24
City
Kerrville
State/Province
Texas
ZIP/Postal Code
78028-6071
Country
United States
Facility Name
Glenmark Investigational Site 1
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Glenmark Investigational Site 7
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3749
Country
United States
Facility Name
Glenmark Investigational Site 9
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Glenmark Investigational Site 20
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Glenmark Investigational Site 31
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Glenmark Investigational Site 22
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
Glenmark Investigational Site 23
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53288
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35926824
Citation
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.
Results Reference
derived

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

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