Trial Outcomes & Findings for Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR) (NCT NCT02870205)

Last Updated: 2018-04-06

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). Symptom scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate).

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1176 participants

Primary outcome timeframe

Baseline and day 14

Results posted on

2018-04-06

Participant Flow

Participant milestones

Participant milestones
Measure	GSP 301 Placebo NS 2 sprays/nostril twice daily for 14 days	GSP 301 NS 2 sprays/nostril twice daily for 14 days	Olopatadine HCl NS 2 sprays/nostril twice daily for 14 days	Mometasone Furoate NS 2 sprays/nostril twice daily for 14 days
Overall Study STARTED	294	294	294	294
Overall Study COMPLETED	284	289	287	287
Overall Study NOT COMPLETED	10	5	7	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of GSP 301 Nasal Spray in the Treatment of Seasonal Allergic Rhinitis (SAR)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	GSP 301 Placebo NS n=293 Participants 2 sprays/nostril twice daily for 14 days	GSP 301 NS n=293 Participants 2 sprays/nostril twice daily for 14 days	Olopatadine HCl NS n=293 Participants 2 sprays/nostril twice daily for 14 days	Mometasone Furoate NS n=293 Participants 2 sprays/nostril twice daily for 14 days	Total n=1172 Participants Total of all reporting groups
Age, Continuous	39.6 years STANDARD_DEVIATION 14.93 • n=5 Participants	39.9 years STANDARD_DEVIATION 14.91 • n=7 Participants	39.9 years STANDARD_DEVIATION 14.62 • n=5 Participants	39.2 years STANDARD_DEVIATION 14.86 • n=4 Participants	39.6 years STANDARD_DEVIATION 14.81 • n=21 Participants
Sex: Female, Male Female	176 Participants n=5 Participants	202 Participants n=7 Participants	189 Participants n=5 Participants	170 Participants n=4 Participants	737 Participants n=21 Participants
Sex: Female, Male Male	117 Participants n=5 Participants	91 Participants n=7 Participants	104 Participants n=5 Participants	123 Participants n=4 Participants	435 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and day 14

Population: The FAS was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.

Outcome measures

Outcome measures
Measure	GSP 301 Placebo NS n=293 Participants 2 sprays/nostril twice daily for 14 days	GSP 301 NS n=292 Participants 2 sprays/nostril twice daily for 14 days	Olopatadine HCl NS n=293 Participants 2 sprays/nostril twice daily for 14 days	Mometasone Furoate NS n=294 Participants 2 sprays/nostril twice daily for 14 days
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) Baseline	10.3 units on a scale Standard Deviation 1.2	10.1 units on a scale Standard Deviation 1.2	10.2 units on a scale Standard Deviation 1.3	10.2 units on a scale Standard Deviation 1.3
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) Change from baseline to end of treatment	-2.9 units on a scale Standard Deviation 3.2	-4.3 units on a scale Standard Deviation 3.1	-3.6 units on a scale Standard Deviation 3.3	-3.5 units on a scale Standard Deviation 3.5

Adverse Events

GSP 301 Placebo NS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

GSP 301 NS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olopatadine HCl NS

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Mometasone Furoate NS

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	GSP 301 Placebo NS n=294 participants at risk 2 sprays/nostril twice daily for 14 days	GSP 301 NS n=294 participants at risk 2 sprays/nostril twice daily for 14 days	Olopatadine HCl NS n=294 participants at risk 2 sprays/nostril twice daily for 14 days	Mometasone Furoate NS n=293 participants at risk 2 sprays/nostril twice daily for 14 days
Infections and infestations Osteomyelitis	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Infections and infestations Diverticulitis	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Infections and infestations Peritonsillar abscess	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.34% 1/293 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Nervous system disorders Ischaemic stroke	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Nervous system disorders Syncope	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Gastrointestinal disorders Large intestinal obstruction	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Gastrointestinal disorders Large intestine perforation	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded
Injury, poisoning and procedural complications Foot fracture	0.34% 1/294 • Number of events 1 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/294 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded	0.00% 0/293 • The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., 7-10 days of screening and placebo run-in and 14 days of treatment. Mometasone furoate NS: 1 subject received wrong kit and was excluded

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 Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the CRO/Sponsor.
Publication restrictions are in place

Restriction type: OTHER