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

Phase 3

Completed

Conditions: Seasonal Allergic Rhinitis (SAR)

Interventions: Drug: GSP 301 Placebo NS
Drug: GSP 301 NS

Registration Number: NCT03463031

Lead Sponsor: Glenmark Specialty S.A.

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 446

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GSP 301 Placebo NS	GSP 301 Placebo NS	GSP 301 Placebo nasal spray
GSP 301 NS	GSP 301 NS	Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period	Baseline and day 14	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

Name	Time	Method
Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.	Baseline and day 14	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 Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.	Baseline and day 14	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.
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)	Baseline and day 15	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.

Trial Locations

Locations (32): Glenmark Investigational Site 19
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Bethesda, Maryland, United States
Glenmark Investigational Site 30
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Paramount, California, United States
Glenmark Investigational Site 17
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San Diego, California, United States
Glenmark Investigational Site 32
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Ontario, California, United States
Glenmark Investigational Site 21
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Colorado Springs, Colorado, United States
Glenmark Investigational Site 28
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Louisville, Kentucky, United States
Glenmark Investigational Site 26
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Savannah, Georgia, United States
Glenmark Investigational Site 13
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Marietta, Georgia, United States
Glenmark Investigational Site 14
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Baltimore, Maryland, United States
Glenmark Investigational Site 12
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Columbia, Missouri, United States
Glenmark Investigational Site 25
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Ypsilanti, Michigan, United States
Glenmark Investigational Site 15
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Omaha, Nebraska, United States
Glenmark Investigational Site 10
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Rolla, Missouri, United States
Glenmark Investigational Site 27
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Warrensburg, Missouri, United States
Glenmark Investigational Site 3
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High Point, North Carolina, United States
Glenmark Investigational Site 11
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Cincinnati, Ohio, United States
Glenmark Investigational Site 4
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Medford, Oregon, United States
Glenmark Investigational Site 5
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Austin, Texas, United States
Glenmark Investigational Site 2
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Edmond, Oklahoma, United States
Glenmark Investigational Site 33
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Tulsa, Oklahoma, United States
Glenmark Investigational Site 1
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New Braunfels, Texas, United States
Glenmark Investigational Site 6
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Spartanburg, South Carolina, United States
Glenmark Investigational Site 24
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Kerrville, Texas, United States
Glenmark Investigational Site 7
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San Antonio, Texas, United States
Glenmark Investigational Site 20
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Waco, Texas, United States
Glenmark Investigational Site 31
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Waco, Texas, United States
Glenmark Investigational Site 22
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Draper, Utah, United States
Glenmark Investigational Site 8
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Raleigh, North Carolina, United States
Glenmark Investigational Site 18
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Mission Viejo, California, United States
Glenmark Investigational Site 29
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Cincinnati, Ohio, United States
Glenmark Investigational Site 9
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San Antonio, Texas, United States
Glenmark Investigational Site 23
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Greenfield, Wisconsin, United States