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.
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.
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
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)
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
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Glenmark Specialty S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudeesh Tantry, PhD, Study director, Glenmark Pharmaceuticals S.A.
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
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 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
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
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.
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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.