Trial · NCT02631551

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

NCT02631551, Phase 3, Completed, Glenmark Specialty S.A.; results first posted 2018-08-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR). Trials, record NCT02631551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02631551

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
NCT number: NCT02631551
Status: Completed
Phases: Phase 3
Enrollment: 1,180 participants, actual
Lead sponsor: Glenmark Specialty S.A.
Conditions: Seasonal Allergic Rhinitis
Interventions: GSP 301 NS, Olopatadine HCl NS, Mometasone furoate NS, GSP 301 Placebo NS
First posted: 2015-12-16
Last updated: 2018-09-25
Results first posted: 2018-08-15

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	14 days	Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging 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).

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	14 days	The Full Analysis Set (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.	units on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	GSP 301 NS	Baseline	10.1	Standard Deviation 1.2	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	Olopatadine HCl NS	Baseline	10.3	Standard Deviation 1.3	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	Mometasone Furoate NS	Baseline	10.2	Standard Deviation 1.2	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	GSP 301 Placebo NS	Baseline	10.2	Standard Deviation 1.2	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	GSP 301 NS	Change from baseline to end of treatment	-3.6	Standard Deviation 3.2	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	Olopatadine HCl NS	Change from baseline to end of treatment	-3.2	Standard Deviation 3.1	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	Mometasone Furoate NS	Change from baseline to end of treatment	-3.5	Standard Deviation 3.3	units on a scale
Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.	GSP 301 Placebo NS	Change from baseline to end of treatment	-2.8	Standard Deviation 3.2	units on a scale

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	GSP 301 NS	302
Overall Study	STARTED	Olopatadine HCl NS	297
Overall Study	STARTED	Mometasone Furoate NS	294
Overall Study	STARTED	GSP 301 Placebo NS	287
Overall Study	COMPLETED	GSP 301 NS	289
Overall Study	COMPLETED	Olopatadine HCl NS	278
Overall Study	COMPLETED	Mometasone Furoate NS	283
Overall Study	COMPLETED	GSP 301 Placebo NS	276
Overall Study	NOT COMPLETED	GSP 301 NS	13
Overall Study	NOT COMPLETED	Olopatadine HCl NS	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events4

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
serious	Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	GSP 301 NS	1	302	1
serious	Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Olopatadine HCl NS	0	297	0
serious	Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	Mometasone Furoate NS	0	294	0
serious	Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	GSP 301 Placebo NS	0	287	0

Source ClinicalTrials.gov

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GSP 301 NS	0	302
Total, all-cause mortality	Olopatadine HCl NS	0	297
Total, all-cause mortality	Mometasone Furoate NS	0	294
Total, all-cause mortality	GSP 301 Placebo NS	0	287
Total, other adverse events	GSP 301 NS	0	302
Total, other adverse events	Olopatadine HCl NS	0	297
Total, other adverse events	Mometasone Furoate NS	0	294
Total, other adverse events	GSP 301 Placebo NS	0	287
Total, serious adverse events	GSP 301 NS	1	302
Total, serious adverse events	Olopatadine HCl NS	0	297

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31053180	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02631551

GET https://conductscience.org/api/trials/v1/NCT02631551/registered

API reference For AI assistants