Trial Outcomes & Findings for To Study GSP 301 in Patients With Seasonal Allergic Rhinitis (NCT NCT02318303)

NCT ID: NCT02318303

Last Updated: 2020-10-20

Results Overview

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 \[i.e., causes interference with activities of daily living and/or sleeping\])

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 1111 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2020-10-20

Participant Flow

Subjects were enrolled at 10 sites in the US.

Participant milestones

Measure	GSP 301 Placebo NS GSP 301 placebo NS administered as 2 sprays/nostril	GSP 301-1 NS (QD) GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril	Mometasone Furoate-1 NS (QD) Mometasone furoate-1 NS (50 μg) administered as 2 sprays/nostril	Olopatadine HCl-1 NS (QD) Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril	GSP 301-2 NS (BID) GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril	Mometasone Furoate-2 NS (BID) Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril	Olopatadine HCl-2 NS (BID) Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Overall Study STARTED	159	158	160	158	157	159	160
Overall Study COMPLETED	155	155	157	155	152	153	158
Overall Study NOT COMPLETED	4	3	3	3	5	6	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

Baseline characteristics by cohort

Measure	GSP 301 Placebo NS n=159 Participants GSP 301 placebo NS administered as 2 sprays/nostril	GSP 301-1 NS (QD) n=158 Participants GSP 301-1 NS administered as 2 sprays/nostril	Mometasone Furoate-1 NS (QD) n=160 Participants Mometasone furoate-1 NS administered as 2 sprays/nostril	Olopatadine HCl-1 NS (QD) n=158 Participants Olopatadine HCl-1 NS administered as 2 sprays/nostril	GSP 301-2 NS (BID) n=157 Participants GSP 301-2 NS administered as 2 sprays/nostril	Mometasone Furoate-2 NS (BID) n=159 Participants Mometasone furoate-2 NS administered as 2 sprays/nostril	Olopatadine HCl-2 NS (BID) n=160 Participants Olopatadine HCl-2 NS administered as 2 sprays/nostril	Total n=1111 Participants Total of all reporting groups
Age, Continuous	45.35 years STANDARD_DEVIATION 14.951 • n=5 Participants	43.83 years STANDARD_DEVIATION 13.609 • n=7 Participants	44.40 years STANDARD_DEVIATION 14.312 • n=5 Participants	41.90 years STANDARD_DEVIATION 12.478 • n=4 Participants	43.44 years STANDARD_DEVIATION 14.128 • n=21 Participants	44.58 years STANDARD_DEVIATION 13.698 • n=10 Participants	43.49 years STANDARD_DEVIATION 13.868 • n=115 Participants	43.86 years STANDARD_DEVIATION 13.882 • n=24 Participants
Sex: Female, Male Female	112 Participants n=5 Participants	100 Participants n=7 Participants	115 Participants n=5 Participants	105 Participants n=4 Participants	111 Participants n=21 Participants	96 Participants n=10 Participants	101 Participants n=115 Participants	740 Participants n=24 Participants
Sex: Female, Male Male	47 Participants n=5 Participants	58 Participants n=7 Participants	45 Participants n=5 Participants	53 Participants n=4 Participants	46 Participants n=21 Participants	63 Participants n=10 Participants	59 Participants n=115 Participants	371 Participants n=24 Participants

PRIMARY outcome

Timeframe: 14 days

Population: The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses.

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])

Outcome measures

Measure	GSP 301-2 NS (BID) n=157 Participants GSP 301-2 NS (BID) administered as 2 sprays/nostril	Mometasone Furoate-2 NS (BID) n=159 Participants Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril	Olopatadine HCl-2 NS (BID) n=160 Participants Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril	GSP 301 Placebo n=158 Participants GSP 301 placebo NS administered as 2 sprays/nostril	GSP 301-1 NS (QD) n=158 Participants GSP 301-1 NS (QD) administered as 2 sprays/nostril	Mometasone Furoate-1 NS (QD) n=160 Participants Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril	Olopatadine HCl-1 NS (QD) n=158 Participants Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril
Change in rTNSS From Baseline to End of Treatment Baseline	10.4 units on a scale Standard Deviation 1.19	10.5 units on a scale Standard Deviation 1.13	10.3 units on a scale Standard Deviation 1.24	10.3 units on a scale Standard Deviation 1.18	10.4 units on a scale Standard Deviation 1.24	10.4 units on a scale Standard Deviation 1.30	10.3 units on a scale Standard Deviation 1.26
Change in rTNSS From Baseline to End of Treatment Change from Baseline to Visit 4	-2.6 units on a scale Standard Deviation 2.56	-1.9 units on a scale Standard Deviation 1.88	-2.1 units on a scale Standard Deviation 2.26	-1.4 units on a scale Standard Deviation 2.00	-2.5 units on a scale Standard Deviation 2.52	-2.2 units on a scale Standard Deviation 2.68	-1.7 units on a scale Standard Deviation 2.09

Adverse Events

GSP 301 Placebo NS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GSP 301-1 NS (QD)

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Mometasone Furoate-1 NS (QD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olopatadine HCl-1 NS (QD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

GSP 301-2 NS (BID)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mometasone Furoate-2 NS (BID)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Olopatadine HCl-2 NS (BID)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	GSP 301 Placebo NS n=159 participants at risk GSP 301 placebo NS administered as 2 sprays/nostril	GSP 301-1 NS (QD) n=158 participants at risk GSP 301-1 NS (QD) administered as 2 sprays/nostril	Mometasone Furoate-1 NS (QD) n=160 participants at risk Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril	Olopatadine HCl-1 NS (QD) n=158 participants at risk Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril	GSP 301-2 NS (BID) n=157 participants at risk GSP 301-2 NS (BID) administered as 2 sprays/nostril.	Mometasone Furoate-2 NS (BID) n=159 participants at risk Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril	Olopatadine HCl-2 NS (BID) n=160 participants at risk Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril
Gastrointestinal disorders Gastrointestinal ulcer and Gastritis	0.00% 0/159 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact	0.63% 1/158 • Number of events 2 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact	0.00% 0/160 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact	0.00% 0/158 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact	0.00% 0/157 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact	0.00% 0/159 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact	0.00% 0/160 • AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact

Other adverse events

Adverse event data not reported

Additional Information

Cathy Tyrrell

Glenmark Pharmaceuticals Ltd

Phone: 91 2267720000

Email: clinicaltrialsdisclosuredesk@glenmarkpharma.com

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