Trial · NCT02709538

Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)

NCT02709538, Phase 3, Completed, Glenmark Specialty S.A.; results first posted 2018-09-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR). Trials, record NCT02709538. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02709538

On this page

Trial

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

Title: Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
NCT number: NCT02709538
Status: Completed
Phases: Phase 3
Enrollment: 601 participants, actual
Lead sponsor: Glenmark Specialty S.A.
Conditions: Perennial Allergic Rhinitis
Interventions: GSP 301 NS, GSP 301 Placebo NS pH 3.7, GSP 301 Placebo NS pH 7.0
First posted: 2016-03-16
Last updated: 2020-02-26
Results first posted: 2018-09-13

Source ClinicalTrials.gov

Registered outcomes1

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

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-emergent Adverse Events (TEAEs).	52 weeks	All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.

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	Number of Participants With Treatment-emergent Adverse Events (TEAEs).	52 weeks	Safety Analysis Set (SAS) will consist of all subjects who took at least 1 dose of study medication following randomization. This was the primary analysis set for safety analyses.	participants	NUMBER

Source ClinicalTrials.gov

Results by group3

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

Outcome	Group	Value	Units
Number of Participants With Treatment-emergent Adverse Events (TEAEs).	GSP 301 NS	203	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs).	GSP 301 Placebo NS pH 3.7	41	participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs).	GSP 301 Placebo NS pH 7.0	54	participants

Source ClinicalTrials.gov

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	GSP 301 NS	400
Overall Study	STARTED	GSP 301 Placebo NS pH 3.7	100
Overall Study	STARTED	GSP 301 Placebo NS pH 7.0	101
Overall Study	COMPLETED	GSP 301 NS	287
Overall Study	COMPLETED	GSP 301 Placebo NS pH 3.7	72
Overall Study	COMPLETED	GSP 301 Placebo NS pH 7.0	81
Overall Study	NOT COMPLETED	GSP 301 NS	113
Overall Study	NOT COMPLETED	GSP 301 Placebo NS pH 3.7	28
Overall Study	NOT COMPLETED	GSP 301 Placebo NS pH 7.0	20

Source ClinicalTrials.gov

Adverse events45

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
other	Nasopharyngitis	Infections and infestations	GSP 301 NS	12	393	14
other	Nasopharyngitis	Infections and infestations	GSP 301 Placebo NS pH 3.7	5	99	6
other	Nasopharyngitis	Infections and infestations	GSP 301 Placebo NS pH 7.0	6	101	6
other	Upper respiratory tract infection	Infections and infestations	GSP 301 NS	25	393	30
other	Upper respiratory tract infection	Infections and infestations	GSP 301 Placebo NS pH 3.7	6	99	8
other	Upper respiratory tract infection	Infections and infestations	GSP 301 Placebo NS pH 7.0	9	101	12
other	Headache	Nervous system disorders	GSP 301 NS	16	393	18
other	Headache	Nervous system disorders	GSP 301 Placebo NS pH 3.7	3	99	3
other	Headache	Nervous system disorders	GSP 301 Placebo NS pH 7.0	5	101	5
other	Epistaxis	Respiratory, thoracic and mediastinal disorders	GSP 301 NS	18	393	23

1 to 10 of 45Source ClinicalTrials.gov

See all 45 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	GSP 301 NS	0	393
Total, all-cause mortality	GSP 301 Placebo NS pH 3.7	0	99
Total, all-cause mortality	GSP 301 Placebo NS pH 7.0	0	101
Total, other adverse events	GSP 301 NS	72	393
Total, other adverse events	GSP 301 Placebo NS pH 3.7	15	99
Total, other adverse events	GSP 301 Placebo NS pH 7.0	25	101
Total, serious adverse events	GSP 301 NS	7	393
Total, serious adverse events	GSP 301 Placebo NS pH 3.7	2	99
Total, serious adverse events	GSP 301 Placebo NS pH 7.0	2	101

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31248471	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/NCT02709538

GET https://conductscience.org/api/trials/v1/NCT02709538/events?page=2

API reference For AI assistants