Seasonal Allergic Rhinitis (SAR)Phase 3GSP 301-304NCT02870205

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

A Phase 3 study testing GSP 301 NS, GOM-NS and GMM-2 NS in people with Seasonal Allergic Rhinitis (SAR), run by Glenmark Specialty S.A. at 43 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older) Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Seasonal Allergic Rhinitis (SAR)
What is being tested?: GSP 301 NS, GOM-NS and GMM-2 NS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,176 participants
Where: 43 sitesUnited States
Study dates: Aug 2016to Jan 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Males and non-pregnant females who are 12 years of age and older.
Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Who cannot join

Pregnant or lactating women.
History of anaphylaxis and/or other severe local reaction(s) to skin testing.
History of positive test for HIV, Hepatitis B or Hepatitis C infection.
Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
Subjects with an active pulmonary disorder or infection.
Subjects with posterior subcapsular cataracts or glaucoma
Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.

Trial locations and contacts

43 sites in 1 country.

City, postcode or hospital

43 sites in 1 country

United States43 sites

Investigational Site 415
Austin, Texas
Investigational Site 442
Austin, Texas
Investigational Site 428
Aventura, Florida
Investigational Site 405
Bellevue, Nebraska
Investigational Site 436
Bethesda, Maryland
Investigational Site 417
Boerne, Texas
Investigational Site 420
Centennial, Colorado
Investigational Site 419
Cincinnati, Ohio
United States 404
Cincinnati, Ohio
Investigational Site 444
Colorado Springs, Colorado
Investigational Site 443
Columbia, Missouri
Investigational Site 421
Dallas, Texas
Investigational Site 430
Dallas, Texas
Investigational Site 423
Draper, Utah
United States 407
Edmond, Oklahoma
Investigational Site 431
El Paso, Texas
Investigational Site 439
Greenfield, Wisconsin
Investigational Site 402
High Point, North Carolina
Investigational Site 433
Kerrville, Texas
Investigational Site 412
Miami, Florida
Investigational Site 426
Minneapolis, Minnesota
Investigational Site 406
Mission Viejo, California
Investigational Site 422
New Braunfels, Texas
Investigational Site 410
Oklahoma City, Oklahoma
Investigational Site 414
Orange, California
Investigational Site 411
Pittsburgh, Pennsylvania
Investigational Site 403
Plymouth, Minnesota
Investigational Site 427
Raleigh, North Carolina
Investigational Site 408
Rochester, New York
Investigational Site 418
Rockville Centre, New York
Investigational Site 441
Rolla, Missouri
Investigational Site 401
San Antonio, Texas
Investigational Site 413
San Antonio, Texas
Investigational Site 425
San Antonio, Texas
Investigational Site 437
San Antonio, Texas
Investigational Site 435
San Diego, California
Investigational Site 434
Skillman, New Jersey
Investigational Site 432
South Dartmouth, Massachusetts
Investigational Site 416
Spartanburg, South Carolina
Investigational Site 440
St Louis, Missouri
Investigational Site 424
Tulsa, Oklahoma
Investigational Site 400
Waco, Texas
Investigational Site 409
Waco, Texas

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)

Conditions: Seasonal Allergic Rhinitis (SAR)
Being tested: GSP 301 NS, GOM-NS, GMM-2 NS, GSP 301 placebo NS
Medical subject headings: Rhinitis, Allergic, Seasonal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSP 301 NSDrug
2 spray in each nostril twice daily for 14 days
GOM-NSDrug
2 spray in each nostril twice daily for 14 days
GMM-2 NSDrug
2 spray in each nostril twice daily for 14 days
GSP 301 placebo NSDrug
2 spray in each nostril twice daily for 14 days

Study groups in NCT02870205
Study group	Role	What they receive
GSP 301 NS	Experimental	Not described Receives: Drug: GSP 301 NS
GOM-NS	Active comparator	Not described Receives: Drug: GOM-NS
GMM-2 NS	Active comparator	Not described Receives: Drug: GMM-2 NS
GSP 301 placebo NS	Placebo comparator	Not described Receives: Drug: GSP 301 placebo NS

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
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).
Measured: Baseline and day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2016Jan 2017

First posted17 Aug 2016 (estimated)
Study startAug 2016
Primary completionJan 2017
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Seasonal Allergic Rhinitis (SAR)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,176 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02870205
Sponsor's protocol ID: GPL/CT/2015/004/III
Other IDs: Study Number: GSP 301-304
Acronym: GSP 301-304
Status last verified: Apr 2018
First submitted: 12 Aug 2016
Last updated: 6 Apr 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.
PubMed 30910440

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
RecruitingPhase 3
Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis
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Not yet recruitingPhase 2
Study of Stapokibart Injection in Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
Seasonal Allergic Rhinitis (SAR)
RecruitingPhase 2
A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure
Seasonal Allergic Rhinitis (SAR)
Not yet recruitingPhase 3
A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis, SAR

All Seasonal Allergic Rhinitis (SAR) trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
ClinicalTrials.gov ID: NCT02870205
Acronym / sponsor ID: GSP 301-304 / GPL/CT/2015/004/III
Conditions: Seasonal Allergic Rhinitis (SAR)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,176 participants (actual)
Lead sponsor: Glenmark Specialty S.A.Industry (pharma, biotech, devices)
Study start: Aug 2016 (actual)
Primary completion: Jan 2017 (actual)
Study completion: Jan 2017 (actual)
First posted: 17 Aug 2016 (estimated)
Results: Posted 6 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
GSP 301 NS	Experimental	Drug: GSP 301 NS
GOM-NS	Active comparator	Drug: GOM-NS
GMM-2 NS	Active comparator	Drug: GMM-2 NS
GSP 301 placebo NS	Placebo comparator	Drug: GSP 301 placebo NS

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Males and non-pregnant females who are 12 years of age and older.
Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen)
A 12-hour rTNSS ≥8 out of a possible 12 and a congestion score ≥2 for the AM assessment at the Screening Visit (Visit 1).

Key exclusion criteria (7 listed)

Pregnant or lactating women.
History of anaphylaxis and/or other severe local reaction(s) to skin testing.
History of positive test for HIV, Hepatitis B or Hepatitis C infection.
Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip.
Subjects with an active pulmonary disorder or infection.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GSP 301 NS2 spray in each nostril twice daily for 14 days	Drug	GSP 301 NS
GOM-NS2 spray in each nostril twice daily for 14 days	Drug	GOM-NS
GMM-2 NS2 spray in each nostril twice daily for 14 days	Drug	GMM-2 NS
GSP 301 placebo NS2 spray in each nostril twice daily for 14 days	Drug	GSP 301 placebo NS

Primary outcome

Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)
Time frame: Baseline and day 14
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).

Results and safety

Results posted to the registry on 6 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSP 301 Placebo NS	294	284
GSP 301 NS	294	289
Olopatadine HCl NS	294	287
Mometasone Furoate NS	294	287

Primary outcome: Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS)

Time frame: Baseline and day 14. Mean (Standard Deviation). Unit: units on a scale

Measure	GSP 301 Placebo NS n = 293	GSP 301 NS n = 292	Olopatadine HCl NS n = 293	Mometasone Furoate NS n = 294
Baseline	10.3 (1.2)	10.1 (1.2)	10.2 (1.3)	10.2 (1.3)
Change from baseline to end of treatment	-2.9 (3.2)	-4.3 (3.1)	-3.6 (3.3)	-3.5 (3.5)

GSP 301 Placebo NS vs GSP 301 NS: p <0.001, ANCOVA
GSP 301 NS vs Olopatadine HCl NS: p = 0.028, ANCOVA
GSP 301 NS vs Mometasone Furoate NS: p = 0.019, ANCOVA

Population analysed: 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.

Adverse events

Time frame: 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.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSP 301 Placebo NS	1 of 294 (0.3%)	0 of 294 (0%)	Not reported
GSP 301 NS	0 of 294 (0%)	0 of 294 (0%)	Not reported
Olopatadine HCl NS	2 of 294 (0.7%)	0 of 294 (0%)	Not reported
Mometasone Furoate NS	1 of 293 (0.3%)	0 of 293 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30910440Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22.

Related trials for Seasonal Allergic Rhinitis (SAR)

Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis (SAR), Allergic Rhinitis
RecruitingPhase 3
Study on the Treatment of Adolescent Patients With Seasonal Allergic Rhinitis
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Not yet recruitingPhase 2
Study of Stapokibart Injection in Adolescent Subjects With Seasonal Allergic Rhinitis (SAR)
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RecruitingPhase 2
A Study to Determine the Optimal Dose and Frequency of ALDP001 Nasal Spray in Adults With Seasonal Allergic Rhinitis Under Allergen Exposure
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Not yet recruitingPhase 3
A Phase III Study to Assess the Efficacy and Safety of PG-011 Nasal Spray in Adults With Moderate to Severe Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis, SAR

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sudeesh Tantry, PhD study director

Glenmark Pharmaceuticals Ltd

43 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSP 301 NS, GOM-NS and GMM-2 NS in people with Seasonal Allergic Rhinitis (SAR), run by Glenmark Specialty S.A. at 43 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) (time frame: Baseline and day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02870205, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018; AzTrials last refreshed its copy on 8 Nov 2026.