Seasonal Allergic RhinitisPhase 2GSP 301- PoCNCT03444506

Efficacy and Safety of Fixed Dose Combination (FDC) of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray (Molo; Also Referred as GSP 301) in the Treatment of Seasonal Allergic Rhinitis (SAR)

A Phase 2 study testing Molo 1 (also referred as GSP 301-2 NS), Molo 2 (also referred as GSP 301-1 NS) and DYMISTA nasal spray in people with Seasonal Allergic Rhinitis, run by Glenmark Pharmaceuticals Ltd. India at 1 site in Canada.

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

A single-center, double-blind, placebo-controlled study of FDC olopatadine hydrochloride and mometasone furoate nasal spray (Molo; also referred as GSP 301) was conducted in subjects with seasonal allergic rhinitis. In this study, the efficacy and safety of two regimens (BID and QD) of the FDC (i.e. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Seasonal Allergic Rhinitis
What is being tested?: Molo 1 (also referred as GSP 301-2 NS), Molo 2 (also referred as GSP 301-1 NS) and DYMISTA nasal spray
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 180 participants
Where: 1 siteCanada
Study dates: 27 Jan 2014to 28 Feb 2014
Phase: Phase 2
Are there results?: None posted in the registry

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 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test

Who cannot join

Pregnant or lactating women
Patients with known hypersensitivity to any of the components of the formulation
Patients with a history of seasonal asthma during ragweed season.
Patient requiring chronic use of inhaled or systemic corticosteroids
Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening
Patients with history of acute or significant chronic sinusitis or chronic purulent post-nasal drip or Rhinitis Medicamentosa as determined by the Investigator.
Patients with history of narrow-angle glaucoma, increased intraocular pressure, posterior subcapsular cataract, urinary retention, uncontrolled hypertension, severe Coronary Artery Disease, Ischemic Heart Disease, uncontrolled Diabetes Mellitus, Hyperthyroidism, Renal Impairment or Prostatic Hypertrophy, and those receiving MAO inhibitor therapy.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Glenmark Investigational Site 1
Mississauga, Ontario, L4W 1V7

Other trials in Canada

About this study

Official title: A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.

Conditions: Seasonal Allergic Rhinitis
Being tested: Molo 1 (also referred as GSP 301-2 NS), Molo 2 (also referred as GSP 301-1 NS), Placebo nasal spray, DYMISTA nasal spray, PATANASE nasal spray
Keywords: SAR
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.

Molo 1 (also referred as GSP 301-2 NS)Drug
Molo 2 (also referred as GSP 301-1 NS)Drug
Placebo nasal sprayDrug
DYMISTA nasal sprayDrug
PATANASE nasal sprayDrug

Study groups in NCT03444506
Study group	Role	What they receive
Placebo nasal spray	Placebo comparator	Placebo nasal spray - 2 sprays per nostril, BID Receives: Drug: Placebo nasal spray
Molo 1 (also referred as GSP 301-2 NS)	Experimental	Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg nasal spray) - 2 sprays per nostril, BID Receives: Drug: Molo 1 (also referred as GSP 301-2 NS)
Molo 2 (also referred as GSP 301-1 NS)	Experimental	Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 50 mcg nasal spray) - 2 sprays per nostril, QD Receives: Drug: Molo 2 (also referred as GSP 301-1 NS)
DYMISTA nasal spray	Active comparator	Fixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID Receives: Drug: DYMISTA nasal spray
PATANASE nasal spray	Active comparator	Olopatadine hydrochloride 665 mcg nasal spray - 2 sprays per nostril, BID Receives: Drug: PATANASE nasal spray

What is being measured

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

Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment
Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Measured: 15 days

Secondary outcomes (8)

Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase
Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Measured: 15 days
Change in mean post-treatment iTNSS for reference products Dymista and Patanase compared with placebo
Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Measured: 15 days
Onset of action assessed by comparing change in iTNSS after the first dose
Measured: 15 days
Change from baseline in post-treatment instantaneous Total Symptoms Score (iTSS) (Molo 1 and Molo 2 versus Active Comparator)
Instantaneous Total Symptom Score (iTSS) is calculated as the sum of the four individual nasal symptom (nasal congestion, rhinorrhea, nasal itching, sneezing) scores and the three individual ocular symptom (ocular itching, tearing/watering eyes, and ocular redness) scores. Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Measured: 15 days
Change from baseline in individual instantaneous Nasal Symptoms Scores (iNSS) (Molo 1 and Molo 2 versus Active Comparator)
Individual Instantaneous Nasal Symptoms Scores (iNSS) is calculated as the score of individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Measured: 15 days
Change from baseline in instantaneous Total Ocular Symptom Score (iTOSS) (Molo 1 and Molo 2 versus Active Comparator)
Instantaneous Total Ocular Symptom Score (iTOSS) is calculated as the sum of the three individual ocular symptoms (ocular itching, tearing/watering eyes, and ocular redness). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).
Measured: 15 days
Change in mean post-treatment Environmental Exposure Chamber - Rhinoconjunctivitis Quality-of-Life Questionnaire (EEC-QoLQ) scores
The EEC-QoLQ has questions in three domains (non-nose/eye symptoms, practical problems and emotional) related to how much a subject was bothered with symptoms. Subject responds on a 7-point scale with score ranging from 0 (better outcome) to 6 (worse outcome).
Measured: 15 days
Responses to a reflective Global Assessment of Tolerability and Acceptance Questionnaire (GATAQ)
Scale of 0 (very much acceptable) - 6 (not acceptable)
Measured: 15 days

Timeline

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

27 Jan 201428 Feb 2014

First posted23 Feb 2018
Study start27 Jan 2014
Primary completion28 Feb 2014
Study completion28 Feb 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 180 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03444506
Sponsor's protocol ID: GPL/CT/2013/001/II
Acronym: GSP 301- PoC
Status last verified: Jun 2018
First submitted: 15 Feb 2018
Last updated: 20 Jun 2018
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):160-166.e1. doi: 10.1016/j.anai.2018.10.011. Epub 2018 Oct 12.
PubMed 30321655

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 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Center, Double-Blind, Double-Dummy, Randomized, Parallel-Group, Comparative Environmental Exposure Chamber (EEC) Study to Evaluate Efficacy, Safety and Tolerability of Two Fixed Dose Combination (FDC) Products of Olopatadine Hydrochloride and Mometasone Furoate Nasal Spray as Compared to the FDC of Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, Olopatadine Nasal Spray, and Placebo in Patients With Seasonal Allergic Rhinitis.
ClinicalTrials.gov ID: NCT03444506
Acronym / sponsor ID: GSP 301- PoC / GPL/CT/2013/001/II
Conditions: Seasonal Allergic Rhinitis
Keywords: SAR
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 180 participants (actual)
Lead sponsor: Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
Study start: 27 Jan 2014 (actual)
Primary completion: 28 Feb 2014 (actual)
Study completion: 28 Feb 2014 (actual)
First posted: 23 Feb 2018 (actual)
Results: Not posted in the source record

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: 5

Arm	Type	Receives
Placebo nasal spray	Placebo comparator	Drug: Placebo nasal sprayPlacebo nasal spray - 2 sprays per nostril, BID
Molo 1 (also referred as GSP 301-2 NS)	Experimental	Drug: Molo 1 (also referred as GSP 301-2 NS)Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 25 mcg nasal spray) - 2 sprays per nostril, BID
Molo 2 (also referred as GSP 301-1 NS)	Experimental	Drug: Molo 2 (also referred as GSP 301-1 NS)Fixed Dose Combination of Molo nasal spray (olopatadine hydrochloride 665 mcg and mometasone furoate 50 mcg nasal spray) - 2 sprays per nostril, QD
DYMISTA nasal spray	Active comparator	Drug: DYMISTA nasal sprayFixed Dose Combination of azelastine hydrochloride 137 mcg and fluticasone propionate 50 mcg nasal spray - 1 spray per nostril, BID
PATANASE nasal spray	Active comparator	Drug: PATANASE nasal sprayOlopatadine hydrochloride 665 mcg nasal spray - 2 sprays per nostril, BID

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Male and female patients aged 18 to 65 years (inclusive) with a clinical history of seasonal allergic rhinitis (SAR) (for at least 2 years) and exhibiting a positive skin prick test

Key exclusion criteria (7 listed)

Pregnant or lactating women
Patients with known hypersensitivity to any of the components of the formulation
Patients with a history of seasonal asthma during ragweed season.
Patient requiring chronic use of inhaled or systemic corticosteroids
Patients with perennial rhinitis; non-allergic rhinitis; or ocular infection within 3 weeks before the screening

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
Molo 1 (also referred as GSP 301-2 NS)	Drug	Molo 1 (also referred as GSP 301-2 NS)
Molo 2 (also referred as GSP 301-1 NS)	Drug	Molo 2 (also referred as GSP 301-1 NS)
Placebo nasal spray	Drug	Placebo nasal spray
DYMISTA nasal spray	Drug	DYMISTA nasal spray
PATANASE nasal spray	Drug	PATANASE nasal spray

Primary outcome

Change in mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment
Time frame: 15 days
Instantaneous Total Nasal Symptom Score (iTNSS) is calculated as the sum of instantaneous scoring of the severity of four individual nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subject responds on a 4-point severity scale with scores ranging from 0 (no signs/absent) to 3 (severe signs).

8 secondary outcomes

Change in mean post-treatment iTNSS for Molo 1 and Molo 2 compared with reference products Dymista and Patanase
Time frame: 15 days
Change in mean post-treatment iTNSS for reference products Dymista and Patanase compared with placebo
Time frame: 15 days
Onset of action assessed by comparing change in iTNSS after the first dose
Time frame: 15 days
Change from baseline in post-treatment instantaneous Total Symptoms Score (iTSS) (Molo 1 and Molo 2 versus Active Comparator)
Time frame: 15 days
Change from baseline in individual instantaneous Nasal Symptoms Scores (iNSS) (Molo 1 and Molo 2 versus Active Comparator)
Time frame: 15 days
Change from baseline in instantaneous Total Ocular Symptom Score (iTOSS) (Molo 1 and Molo 2 versus Active Comparator)
Time frame: 15 days
Change in mean post-treatment Environmental Exposure Chamber - Rhinoconjunctivitis Quality-of-Life Questionnaire (EEC-QoLQ) scores
Time frame: 15 days
Responses to a reflective Global Assessment of Tolerability and Acceptance Questionnaire (GATAQ)
Time frame: 15 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Derived from this study: PubMed 30321655Patel P, Salapatek AM, Tantry SK. Effect of olopatadine-mometasone combination nasal spray on seasonal allergic rhinitis symptoms in an environmental exposure chamber study. Ann Allergy Asthma Immunol. 2019 Feb;122(2):160-166.e1. doi: 10.1016/j.anai.2018.10.011. Epub 2018 Oct 12.

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
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RecruitingObservational study
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Recruiting
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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.

1 site 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 1 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 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 mean post-treatment instantaneous Total Nasal Symptoms Score (iTNSS) for Molo 1 and Molo 2 compared with placebo from baseline to end of treatment (time frame: 15 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 NCT03444506, 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 Jun 2018.