Seasonal Allergic RhinitisPhase 3GSP 301-301NCT02631551

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

A Phase 3 study testing GSP 301 NS, Olopatadine HCl NS and Mometasone furoate NS in people with Seasonal Allergic Rhinitis, run by Glenmark Specialty S.A. at 37 sites in United States.

Completed

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

Official record

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Trial summary

Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Seasonal Allergic Rhinitis
What is being tested?: GSP 301 NS, Olopatadine HCl NS and Mometasone furoate NS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,180 participants
Where: 37 sitesUnited States
Study dates: Mar 2016to Jul 2016
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

Aged 12 years and older inclusive of either sex.
Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)
A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

Who cannot join

Pregnant or lactating women.
Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
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

Trial locations and contacts

37 sites in 1 country.

City, postcode or hospital

37 sites in 1 country

United States37 sites

Investigational Site 3
Austin, Texas
Investigational Site 5
Austin, Texas
Investigational Site 8
Austin, Texas
Investigational Site 14
Baltimore, Maryland
Investigational Site 16
Bellevue, Nebraska
Investigational Site 25
Centennial, Colorado
Investigational Site 27
Cincinnati, Ohio
Investigational Site 22
Colorado Springs, Colorado
Investigational Site 24
Draper, Utah
Investigational Site 10
Jupiter, Florida
Investigational Site 1
Kerrville, Texas
Investigational Site 11
Louisville, Kentucky
Investigational Site 37
Marietta, Georgia
Investigational Site 32
Medford, Oregon
Investigational Site 30
Miami, Florida
Investigational Site 34
Middleburg Heights, Ohio
Investigational Site 19
Minneapolis, Minnesota
Investigational Site 20
Mission Viejo, California
Investigational Site 7
New Braunfels, Texas
Investigational Site 13
Orangeburg, South Carolina
Investigational Site 35
Portland, Oregon
Investigational Site 18
Raleigh, North Carolina
Investigational Site 36
Rochester, New York
Investigational Site 2
San Antonio, Texas
Investigational Site 4
San Antonio, Texas
Investigational Site 6
San Antonio, Texas
Investigational Site 9
San Antonio, Texas
Investigational Site 31
San Diego, California
Investigational Site 29
San Jose, California
Investigational Site 12
Skillman, New Jersey
Investigational Site 17
Spartanburg, South Carolina
Investigational Site 21
St Louis, Missouri
Investigational Site 15
Stockbridge, Georgia
Investigational Site 23
Stockbridge, Georgia
Investigational Site 28
Waco, Texas
Investigational Site 33
Wheaton, Maryland
Investigational Site 26
Ypsilanti, Michigan

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)

Conditions: Seasonal Allergic Rhinitis
Being tested: GSP 301 NS, Olopatadine HCl NS, Mometasone furoate NS, GSP 301 Placebo NS
Keywords: Seasonal Allergic Rhinitis
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
FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
Olopatadine HCl NSDrug
2 sprays in each nostril twice daily for 14 days
Mometasone furoate NSDrug
2 sprays in each nostril twice daily for 14 days
GSP 301 Placebo NSDrug
2 sprays in each nostril twice daily for 14 days

Study groups in NCT02631551
Study group	Role	What they receive
GSP 301 NS	Experimental	Not described Receives: Drug: GSP 301 NS
Olopatadine HCl NS	Active comparator	Not described Receives: Drug: Olopatadine HCl NS
Mometasone furoate NS	Active comparator	Not described Receives: Drug: Mometasone furoate 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 in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
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).
Measured: 14 days

Timeline

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

Mar 2016Jul 2016

First posted16 Dec 2015 (estimated)
Study startMar 2016
Primary completionJul 2016
Study completionJul 2016

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 RhinitisStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02631551
Sponsor's protocol ID: GPL/CT/2014/016/III
Acronym: GSP 301-301
Status last verified: Aug 2018
First submitted: 10 Dec 2015
Last updated: 25 Sep 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3.
PubMed 31053180

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

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All Seasonal Allergic Rhinitis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Parallel-Group, Comparative Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose Combination GSP 301 Nasal Spray (NS) Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators) in Subjects (Aged 12 Years and Older) With Seasonal Allergic Rhinitis (SAR)
ClinicalTrials.gov ID: NCT02631551
Acronym / sponsor ID: GSP 301-301 / GPL/CT/2014/016/III
Conditions: Seasonal Allergic Rhinitis
Keywords: Seasonal Allergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,180 participants (actual)
Lead sponsor: Glenmark Specialty S.A.Industry (pharma, biotech, devices)
Study start: Mar 2016
Primary completion: Jul 2016 (actual)
Study completion: Jul 2016 (actual)
First posted: 16 Dec 2015 (estimated)
Results: Posted 15 Aug 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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
GSP 301 NS	Experimental	Drug: GSP 301 NS
Olopatadine HCl NS	Active comparator	Drug: Olopatadine HCl NS
Mometasone furoate NS	Active comparator	Drug: Mometasone furoate 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)

Aged 12 years and older inclusive of either sex.
Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) during the spring allergy season (tree/grass pollen)
A 12-hour reflective TNSS ≥ 8 out of a possible 12 and a congestion score of ≥ 2 for the AM assessment at the Screening Visit (Visit 1).

Key exclusion criteria (7 listed)

Pregnant or lactating women.
Plans to travel outside the known pollen area for the investigative site for > 24 hours during the last 7 days of run in period.
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.

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 NSFDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days	Drug	GSP 301 NS
Olopatadine HCl NS2 sprays in each nostril twice daily for 14 days	Drug	Olopatadine HCl NS
Mometasone furoate NS2 sprays in each nostril twice daily for 14 days	Drug	Mometasone furoate NS
GSP 301 Placebo NS2 sprays in each nostril twice daily for 14 days	Drug	GSP 301 Placebo NS

Primary outcome

Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.
Time frame: 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).

Results and safety

Results posted to the registry on 15 Aug 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 NS	302	289
Olopatadine HCl NS	297	278
Mometasone Furoate NS	294	283
GSP 301 Placebo NS	287	276

Primary outcome: Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment.

Time frame: 14 days. Mean (Standard Deviation). Unit: units on a scale

Measure	GSP 301 NS n = 299	Olopatadine HCl NS n = 294	Mometasone Furoate NS n = 294	GSP 301 Placebo NS n = 283
Baseline	10.1 (1.2)	10.3 (1.3)	10.2 (1.2)	10.2 (1.2)
Change from baseline to end of treatment	-3.6 (3.2)	-3.2 (3.1)	-3.5 (3.3)	-2.8 (3.2)

GSP 301 NS vs GSP 301 Placebo NS: p <0.0001, Mixed Models Analysis
GSP 301 NS vs Olopatadine HCl NS: p = 0.0029, Mixed Models Analysis
GSP 301 NS vs Mometasone Furoate NS: p = 0.0587, Mixed Models Analysis

Population analysed: 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.

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., screening visit followed by 7-10 days of placebo run-in period and 14 days of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSP 301 NS	1 of 302 (0.3%)	0 of 302 (0%)	0 of 302
Olopatadine HCl NS	0 of 297 (0%)	0 of 297 (0%)	0 of 297
Mometasone Furoate NS	0 of 294 (0%)	0 of 294 (0%)	0 of 294
GSP 301 Placebo NS	0 of 287 (0%)	0 of 287 (0%)	0 of 287

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31053180Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3.

Related trials for Seasonal Allergic Rhinitis

RecruitingPhase 1
Safety, Tolerability And Pharmacodynamics of DM-101PX in Birch Pollen Allergy
Birch Pollen Allergy
Active, not recruitingPhase 3
A Clinical Study Evaluating the Efficacy and Safety of SHR-1819 Injection in Patients With Seasonal Allergic Rhinitis
Seasonal Allergic Rhinitis
Enrolling by invitationObservational study
Identification of Allergen-reactive Antibodies in the Blood of Pollen Allergic Patients
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RecruitingObservational study
Investigating Nasal and Ocular Immune Response to Conjunctival Allergen Exposure
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Recruiting
Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
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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 S.A.

37 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, Olopatadine HCl NS and Mometasone furoate NS in people with Seasonal Allergic Rhinitis, run by Glenmark Specialty S.A. at 37 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 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 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 15 Aug 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 in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. (time frame: 14 days). 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 NCT02631551, 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 25 Sep 2018.