Seasonal Allergic RhinitisPhase 2NCT02318303

To Study GSP 301 in Patients With Seasonal Allergic Rhinitis

A Phase 2 study testing GSP 301-1 NS (QD), GSP 301-2 NS (BID) and Olopatadine HCl-1 NS (QD) in people with Seasonal Allergic Rhinitis, run by Glenmark Pharmaceuticals Ltd. India at 10 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 two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis. 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 301-1 NS (QD), GSP 301-2 NS (BID) and Olopatadine HCl-1 NS (QD)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,111 participants
Where: 10 sitesUnited States
Study dates: Dec 2014to Feb 2015
Phase: Phase 2
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 study season for the mountain cedar 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 nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
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

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Glenmark Investigational Site 10
Austin, Texas
Glenmark Investigational Site 5
Austin, Texas
Glenmark Investigational Site 6
Austin, Texas
Glenmark Investigational Site 2
Kerrville, Texas
Glenmark Investigational Site 7
New Braunfels, Texas
Glenmark Investigational Site 3
San Antonio, Texas
Glenmark Investigational Site 4
San Antonio, Texas
Glenmark Investigational Site 8
San Antonio, Texas
Glenmark Investigational Site 9
San Antonio, Texas
Glenmark Investigational Site 1
Waco, Texas

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 Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Conditions: Seasonal Allergic Rhinitis
Being tested: GSP 301-1 NS (QD), GSP 301-2 NS (BID), GSP 301 Placebo NS, Olopatadine HCl-1 NS (QD), Olopatadine HCl-2 NS (BID)
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 301-1 NS (QD)Drug
GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301-2 NS (BID)Drug
GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
GSP 301 Placebo NSDrug
GSP 301 placebo NS administered as 2 sprays/nostril
Olopatadine HCl-1 NS (QD)Drug
Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
Olopatadine HCl-2 NS (BID)Drug
Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
Mometasone Furoate-1 NS (QD)Drug
Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
Mometasone Furoate-2 NS (BID)Drug
Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril

Study groups in NCT02318303
Study group	Role	What they receive
GSP 301 Placebo NS	Placebo comparator	Not described Receives: Drug: GSP 301 Placebo NS
GSP 301-1 NS (QD)	Experimental	Not described Receives: Drug: GSP 301-1 NS (QD)
GSP 301-2 NS (BID)	Experimental	Not described Receives: Drug: GSP 301-2 NS (BID)
Olopatadine HCl-1 NS (QD)	Active comparator	Not described Receives: Drug: Olopatadine HCl-1 NS (QD)
Olopatadine HCl-2 NS (BID)	Active comparator	Not described Receives: Drug: Olopatadine HCl-2 NS (BID)
Mometasone Furoate-1 NS (QD)	Active comparator	Not described Receives: Drug: Mometasone Furoate-1 NS (QD)
Mometasone Furoate-2 NS (BID)	Active comparator	Not described Receives: Drug: Mometasone Furoate-2 NS (BID)

What is being measured

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

Change in rTNSS From Baseline to End of Treatment
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])
Measured: 14 days

Timeline

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

Dec 2014Feb 2015

First posted17 Dec 2014 (estimated)
Study startDec 2014
Primary completionFeb 2015
Study completionFeb 2015

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,111 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02318303
Sponsor's protocol ID: GPL/CT/2014/004/II
Other IDs: IND Number: 123164, Study Number (GSP 301-201)
Status last verified: Sep 2020
First submitted: 3 Dec 2014
Last updated: 20 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.
PubMed 31734334

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 20 Oct 2020. 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 Two Different Strengths and Regimens of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Comparators), in Subjects (12 Years of Age and Older) With Seasonal Allergic Rhinitis (SAR)
ClinicalTrials.gov ID: NCT02318303
Acronym / sponsor ID: GPL/CT/2014/004/II
Conditions: Seasonal Allergic Rhinitis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,111 participants (actual)
Lead sponsor: Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Feb 2015 (actual)
Study completion: Feb 2015 (actual)
First posted: 17 Dec 2014 (estimated)
Results: Posted 28 Jun 2017

Clinical summary

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

Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
GSP 301 Placebo NS	Placebo comparator	Drug: GSP 301 Placebo NS
GSP 301-1 NS (QD)	Experimental	Drug: GSP 301-1 NS (QD)
GSP 301-2 NS (BID)	Experimental	Drug: GSP 301-2 NS (BID)
Olopatadine HCl-1 NS (QD)	Active comparator	Drug: Olopatadine HCl-1 NS (QD)
Olopatadine HCl-2 NS (BID)	Active comparator	Drug: Olopatadine HCl-2 NS (BID)
Mometasone Furoate-1 NS (QD)	Active comparator	Drug: Mometasone Furoate-1 NS (QD)
Mometasone Furoate-2 NS (BID)	Active comparator	Drug: Mometasone Furoate-2 NS (BID)

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 study season for the mountain cedar 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 (8 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 nasal polyps of other clinically significant respiratory tract malformations, recent nasal biopsy, nasal trauma (such as nasal piercing) or surgery, atopic dermatitis or rhinitis medicamentosa.
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.

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 301-1 NS (QD)GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril	Drug	GSP 301-1 NS (QD)
GSP 301-2 NS (BID)GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril	Drug	GSP 301-2 NS (BID)
GSP 301 Placebo NSGSP 301 placebo NS administered as 2 sprays/nostril	Drug	GSP 301 Placebo NS
Olopatadine HCl-1 NS (QD)Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril	Drug	Olopatadine HCl-1 NS (QD)
Olopatadine HCl-2 NS (BID)Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril	Drug	Olopatadine HCl-2 NS (BID)
Mometasone Furoate-1 NS (QD)Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril	Drug	Mometasone Furoate-1 NS (QD)
Mometasone Furoate-2 NS (BID)Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril	Drug	Mometasone Furoate-2 NS (BID)

Primary outcome

Change in rTNSS From Baseline to End of Treatment
Time frame: 14 days
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])

Results and safety

Results posted to the registry on 28 Jun 2017, 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	159	155
GSP 301-1 NS (QD)	158	155
Mometasone Furoate-1 NS (QD)	160	157
Olopatadine HCl-1 NS (QD)	158	155
GSP 301-2 NS (BID)	157	152
Mometasone Furoate-2 NS (BID)	159	153
Olopatadine HCl-2 NS (BID)	160	158

Primary outcome: Change in rTNSS From Baseline to End of Treatment

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

Measure	GSP 301 Placebo n = 158	GSP 301-1 NS (QD) n = 158	Mometasone Furoate-1 NS (QD) n = 160	Olopatadine HCl-1 NS (QD) n = 158	GSP 301-2 NS (BID) n = 157	Mometasone Furoate-2 NS (BID) n = 159	Olopatadine HCl-2 NS (BID) n = 160
Baseline	10.3 (1.18)	10.4 (1.24)	10.4 (1.30)	10.3 (1.26)	10.4 (1.19)	10.5 (1.13)	10.3 (1.24)
Change from Baseline to Visit 4	-1.4 (2.00)	-2.5 (2.52)	-2.2 (2.68)	-1.7 (2.09)	-2.6 (2.56)	-1.9 (1.88)	-2.1 (2.26)

GSP 301 Placebo vs GSP 301-1 NS (QD): Mean Difference (Final Values): -1.1087 (97.5% CI -1.6690 to -0.5485), p <0.0001, ANCOVA
GSP 301 Placebo vs GSP 301-2 NS (BID): Mean Difference (Final Values): -1.1703 (97.5% CI -1.7315 to -0.6090), p <0.0001, ANCOVA
GSP 301-1 NS (QD) vs Olopatadine HCl-1 NS (QD): Mean Difference (Final Values): -0.7718 (95% CI -1.2616 to -0.2820), p = 0.0020, ANCOVA

Population analysed: 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.

Adverse events

Time frame: AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSP 301 Placebo NS	0 of 159 (0%)	0 of 159 (0%)	Not reported
GSP 301-1 NS (QD)	1 of 158 (0.6%)	0 of 158 (0%)	Not reported
Mometasone Furoate-1 NS (QD)	0 of 160 (0%)	0 of 160 (0%)	Not reported
Olopatadine HCl-1 NS (QD)	0 of 158 (0%)	0 of 158 (0%)	Not reported
GSP 301-2 NS (BID)	0 of 157 (0%)	0 of 157 (0%)	Not reported
Mometasone Furoate-2 NS (BID)	0 of 159 (0%)	0 of 159 (0%)	Not reported
Olopatadine HCl-2 NS (BID)	0 of 160 (0%)	0 of 160 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31734334Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15.

Related trials for 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, Ph.D study director

Glenmark Pharmaceuticals Ltd

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

Questions about this trial

What is this clinical trial studying?

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 8 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 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 28 Jun 2017). 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 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 NCT02318303, 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 20 Oct 2020.