Trial Outcomes & Findings for Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR) (NCT NCT03463031)

Last Updated: 2019-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

446 participants

Primary outcome timeframe

Baseline and day 14

Results posted on

2019-10-08

Participant Flow

Participant milestones

Participant milestones
Measure	GSP 301 NS Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS. Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS GSP 301 Placebo NS. Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
Overall Study STARTED	225	221
Overall Study COMPLETED	215	216
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	GSP 301 NS Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS. Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS GSP 301 Placebo NS. Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
Overall Study Withdrawal by Subject	4	2
Overall Study Investigator/Sponsor Decision	0	1
Overall Study Lost to Follow-up	1	1
Overall Study Adverse Event	4	1
Overall Study Use of prohibited medication by subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSP 301 NS n=225 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS n=221 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Total n=446 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	44 Participants n=7 Participants	90 Participants n=5 Participants
Race (NIH/OMB) White	168 Participants n=5 Participants	169 Participants n=7 Participants	337 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	8.7 years STANDARD_DEVIATION 1.6 • n=5 Participants	8.6 years STANDARD_DEVIATION 1.7 • n=7 Participants	8.7 years STANDARD_DEVIATION 1.7 • n=5 Participants
Age, Customized 6 - < 9	100 Participants n=5 Participants	99 Participants n=7 Participants	199 Participants n=5 Participants
Age, Customized 9 - < 12	125 Participants n=5 Participants	122 Participants n=7 Participants	247 Participants n=5 Participants
Sex: Female, Male Female	99 Participants n=5 Participants	109 Participants n=7 Participants	208 Participants n=5 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	112 Participants n=7 Participants	238 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=5 Participants	85 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	158 Participants n=5 Participants	135 Participants n=7 Participants	293 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	8 Participants n=5 Participants	5 Participants n=7 Participants	13 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and day 14

Population: The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.

Outcome measures

Outcome measures
Measure	GSP 301 NS n=222 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS n=219 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
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	8.83 units on a scale Standard Deviation 1.41	8.84 units on a scale Standard Deviation 1.66
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period Mean Change from baseline to end of treatment	-2.2 units on a scale Standard Deviation 0.17	-1.6 units on a scale Standard Deviation 0.18

SECONDARY outcome

Timeframe: Baseline and day 14

Population: The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	GSP 301 NS n=222 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS n=219 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
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	7.89 units on a scale Standard Deviation 1.93	7.82 units on a scale Standard Deviation 2.04
Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period. Mean Change from baseline to end of treatment	-1.8 units on a scale Standard Deviation 0.17	-1.1 units on a scale Standard Deviation 0.17

SECONDARY outcome

Timeframe: Baseline and day 15

Population: The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	GSP 301 NS n=222 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS n=219 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4) Baseline	2.51 units on a scale Standard Deviation 1.078	2.42 units on a scale Standard Deviation 1.001
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4) Mean Change from baseline to end of treatment	-0.8 units on a scale Standard Deviation 0.08	-0.5 units on a scale Standard Deviation 0.08

SECONDARY outcome

Timeframe: Baseline and day 14

Population: The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.

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.

Outcome measures

Outcome measures
Measure	GSP 301 NS n=222 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS n=219 Participants Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
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	3.84 units on a scale Standard Deviation 2.45	3.59 units on a scale Standard Deviation 2.52
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period. Mean Change from baseline to end of treatment	-0.8 units on a scale Standard Deviation 0.14	-0.6 units on a scale Standard Deviation 0.13

Adverse Events

GSP 301 NS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo NS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSP 301 NS n=225 participants at risk Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days	Placebo NS n=221 participants at risk Intranasal administration, 1 spray in each nostril BID (AM and PM, approximately 12 hours apart) for 14 days
Infections and infestations Meningitis viral	0.00% 0/225 • AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up contact which was approximately 22 days and up to 27 days with 7 to 10 days of a placebo run-in period and 14 days of treatment period, with allowable window periods for the study visits.	0.45% 1/221 • Number of events 1 • AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up contact which was approximately 22 days and up to 27 days with 7 to 10 days of a placebo run-in period and 14 days of treatment period, with allowable window periods for the study visits.

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Glenmark Pharmaceuticals Ltd

Phone: 201-684 8000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place