Seasonal Allergic Rhinitis (SAR)Phase 3GSP 301-305NCT03463031

Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

A Phase 3 study testing GSP 301 NS in people with Seasonal Allergic Rhinitis (SAR), run by Glenmark Specialty S.A. at 32 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, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR). Read more about this study

Who is it for?: Ages 6 to 11 years
Conditions the study is for: Seasonal Allergic Rhinitis (SAR)
What is being tested?: GSP 301 NS
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 446 participants
Where: 32 sitesUnited States
Study dates: 16 Mar 2018to 14 Nov 2018
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 6 to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and female subjects aged ≥6 to <12 years
Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Who cannot join

Females of childbearing potential or pregnant
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.
History of anaphylaxis and/or other severe local reaction(s) to skin testing
History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
Subjects with an active pulmonary disorder or infection.
Subjects with posterior subcapsular cataracts or glaucoma

Trial locations and contacts

32 sites in 1 country.

City, postcode or hospital

32 sites in 1 country

United States32 sites

Glenmark Investigational Site 5
Austin, Texas, 78759
Glenmark Investigational Site 14
Baltimore, Maryland, 21236-5992
Glenmark Investigational Site 19
Bethesda, Maryland, 20814-2672
Glenmark Investigational Site 11
Cincinnati, Ohio, 45231
Glenmark Investigational Site 29
Cincinnati, Ohio, 45242
Glenmark Investigational Site 21
Colorado Springs, Colorado, 80907
Glenmark Investigational Site 12
Columbia, Missouri, 65203
Glenmark Investigational Site 22
Draper, Utah, 84020
Glenmark Investigational Site 2
Edmond, Oklahoma, 73034
Glenmark Investigational Site 23
Greenfield, Wisconsin, 53288
Glenmark Investigational Site 3
High Point, North Carolina, 27262-4320
Glenmark Investigational Site 24
Kerrville, Texas, 78028-6071
Glenmark Investigational Site 28
Louisville, Kentucky, 40215
Glenmark Investigational Site 13
Marietta, Georgia, 30060
Glenmark Investigational Site 4
Medford, Oregon, 97504-9741
Glenmark Investigational Site 18
Mission Viejo, California, 19406
Glenmark Investigational Site 1
New Braunfels, Texas, 78130
Glenmark Investigational Site 15
Omaha, Nebraska, 68114
Glenmark Investigational Site 32
Ontario, California, 910762
Glenmark Investigational Site 30
Paramount, California, 90723
Glenmark Investigational Site 8
Raleigh, North Carolina, 27607
Glenmark Investigational Site 10
Rolla, Missouri, 65401
Glenmark Investigational Site 7
San Antonio, Texas, 78229-3749
Glenmark Investigational Site 9
San Antonio, Texas, 78229
Glenmark Investigational Site 17
San Diego, California, 92108
Glenmark Investigational Site 26
Savannah, Georgia, 31312
Glenmark Investigational Site 6
Spartanburg, South Carolina, 29303
Glenmark Investigational Site 33
Tulsa, Oklahoma, 74136
Glenmark Investigational Site 20
Waco, Texas, 76712
Glenmark Investigational Site 31
Waco, Texas, 76712
Glenmark Investigational Site 27
Warrensburg, Missouri, 64093
Glenmark Investigational Site 25
Ypsilanti, Michigan, 48197

Other trials in United States

About this study

Official title: A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)

Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Conditions: Seasonal Allergic Rhinitis (SAR)
Being tested: GSP 301 NS, GSP 301 Placebo NS
Keywords: GSP 301 nasal spray for the treatment of 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
1 spray in each nostril twice daily for 14 days
GSP 301 Placebo NSDrug
1 spray in each nostril twice daily for 14 days

Study groups in NCT03463031
Study group	Role	What they receive
GSP 301 NS	Experimental	Fixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS Receives: Drug: GSP 301 NS
GSP 301 Placebo NS	Placebo comparator	GSP 301 Placebo nasal spray 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) Over the 14-day Treatment Period
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). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.
Measured: Baseline and day 14

Secondary outcomes (3)

Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.
The instantaneous Total Nasal Symptom Score (iTNSS) was assessed by instantaneous (ie, an evaluation of the symptom severity just before taking study medication [within 10 minutes]) of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the iTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the iTNSS is summed. The total score of the iTNSS ranged from 0 to 12.
Measured: Baseline and day 14
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)
The PRQLQ is a validated, disease-specific, quality-of-life (QOL) questionnaire developed to measure the physical, emotional, and social impairments that are experienced by children (aged ≥6 to <12 years) with rhinoconjunctivitis. The PRQLQ has 23 questions in 5 domains (nose symptoms, eye symptoms, practical problems, activity limitation and other symptoms). Subjects recall how they have been during the previous week and respond to each question on a 7-point scale with scores ranging from 6 (extremely bothered), 5 (very bothered), 4 (quite bothered), 3 (somewhat bothered), 2 (bothered a bit), 1 (hardly bothered at all), 0 (not bothered). The Overall PRQLQ score is the mean of all 23 subject-reported responses. The Overall PRQLQ score range from 0 to 6 where 0 represents no impairment and 6 represents maximum impairment.
Measured: Baseline and day 15
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.
The Total Ocular Symptom Score (TOSS) will be calculated using the 3 eye-related non-nasal symptoms: itching/burning eyes, tearing/watering eyes, and redness of eyes. The subject will assess and report his/her non-nasal symptoms twice (AM and PM assessments). Scores ranged from 0 (No sign/symptom evident), 1 (Sign/symptom clearly present but minimal awareness; easily tolerated), 2 (Definite awareness of sign/symptom that is bothersome but tolerable) and 3 (Sign/symptom is hard to tolerate; causes interference with activities of daily living and/or sleeping). The Total Ocular Symptom Score (TOSS) ranged from 0 to 9.
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.

16 Mar 201814 Nov 2018

First posted13 Mar 2018
Study start16 Mar 2018
Primary completion14 Nov 2018
Study completion14 Nov 2018

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: 446 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03463031
Sponsor's protocol ID: GSP 301-305
Acronym: GSP 301-305
Status last verified: Sep 2019
First submitted: 5 Mar 2018
Last updated: 8 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022 Nov;129(5):618-626.e2. doi: 10.1016/j.anai.2022.07.029. Epub 2022 Aug 1.
PubMed 35926824

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 (SAR) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blind, Randomized, Parallel-Group Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination GSP 301 Nasal Spray Compared With Placebo Nasal Spray in Pediatric Subjects (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
ClinicalTrials.gov ID: NCT03463031
Acronym / sponsor ID: GSP 301-305 / GSP 301-305
Conditions: Seasonal Allergic Rhinitis (SAR)
Keywords: GSP 301 nasal spray for the treatment of Seasonal Allergic Rhinitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 446 participants (actual)
Lead sponsor: Glenmark Specialty S.A.Industry (pharma, biotech, devices)
Study start: 16 Mar 2018 (actual)
Primary completion: 14 Nov 2018 (actual)
Study completion: 14 Nov 2018 (actual)
First posted: 13 Mar 2018 (actual)
Results: Posted 8 Oct 2019

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 efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
GSP 301 NS	Experimental	Drug: GSP 301 NSFixed dose combination of olopatadine hydrochloride 665 μg and mometasone furoate 25 μg NS
GSP 301 Placebo NS	Placebo comparator	Drug: GSP 301 Placebo NSGSP 301 Placebo nasal spray

Who may qualify

Ages: 6 to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male and female subjects aged ≥6 to <12 years
Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
Signed informed consent/assent form (subject and parent/caregiver/legal guardian)

Key exclusion criteria (6 listed)

Females of childbearing potential or pregnant
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.
History of anaphylaxis and/or other severe local reaction(s) to skin testing
History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal 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 NS1 spray in each nostril twice daily for 14 days	Drug	GSP 301 NS
GSP 301 Placebo NS1 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) Over the 14-day Treatment Period
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). Scores ranged from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate, causes interference with activities of daily living and/or sleeping). Each of these four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching) of the rTNSS is rated on a scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). The four nasal symptoms of the rTNSS is summed. The total score of the rTNSS ranged from 0 to 12.

3 secondary outcomes

Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period.
Time frame: Baseline and day 14
Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4)
Time frame: Baseline and day 15
Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period.
Time frame: Baseline and day 14

Results and safety

Results posted to the registry on 8 Oct 2019, 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	225	215
Placebo NS	221	216

Primary outcome: Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period

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

Measure	GSP 301 NS n = 222	Placebo NS n = 219
Baseline	8.83 (1.41)	8.84 (1.66)
Mean Change from baseline to end of treatment	-2.2 (0.17)	-1.6 (0.18)

GSP 301 NS vs Placebo NS: Least Square Mean Difference: -0.6 (95% CI -0.9 to -0.2), p = 0.001, Mixed Models Analysis

Population analysed: The Full Analysis Set (FAS) consisted of all subjects who are randomized and received at least 1 dose of IP and had at least 1 post-baseline primary efficacy assessment.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected from the time of signing the informed consent form (ICF) until the follow up contact which was approximately 22 days and up to 27 days with 7 to 10 days of a placebo run-in period and 14 days of treatment period, with allowable window periods for the study visits.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSP 301 NS	0 of 225 (0%)	0 of 225 (0%)	0 of 225
Placebo NS	1 of 221 (0.5%)	0 of 221 (0%)	0 of 221

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35926824Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2022 Nov;129(5):618-626.e2. doi: 10.1016/j.anai.2022.07.029. Epub 2022 Aug 1.

Related trials for Seasonal Allergic Rhinitis (SAR)

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 Ltd.

32 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 in people with Seasonal Allergic Rhinitis (SAR), run by Glenmark Specialty S.A. at 32 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 5 inclusion and 6 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 8 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 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 8 Oct 2019). 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) Over the 14-day Treatment Period (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 NCT03463031, 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 8 Oct 2019.