Perennial Allergic RhinitisPhase 3GSP 301-303NCT02709538
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
A Phase 3 study testing GSP 301 NS in people with Perennial Allergic Rhinitis, run by Glenmark Specialty S.A. at 34 sites in United States.
Trial summary
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older) Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- GSP 301 NS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 601 participants
- Where
- 34 sitesUnited States
- Study dates
- Apr 2016to Jul 2017
- 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 PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.
Who cannot join
- Pregnant or lactating women.
- 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
34 sites in 1 country.
34 sites in 1 country
United States34 sites
Investigational Site 23
Austin, Texas
Investigational Site 24
Austin, Texas
Investigational Site 3
Austin, Texas
Investigational Site 26
Aventura, Florida
Investigational Site 30
Bellevue, Nebraska
Investigational Site 5
Bethesda, Maryland
Investigational Site 18
Corning, New York
Investigational Site 31
Dallas, Texas
Investigational Site 32
Denver, Colorado
Investigational Site 34
El Paso, Texas
Investigational Site 28
Encinitas, California
Investigational Site 7
High Point, North Carolina
Investigational Site 2
Hot Springs, Arkansas
Investigational Site 6
Kerrville, Texas
Investigational Site 4
Louisville, Kentucky
Investigational Site 9
Miami, Florida
Investigational Site 14
New Braunfels, Texas
Investigational Site 22
Pittsburgh, Pennsylvania
Investigational Site 21
Raleigh, North Carolina
Investigational Site 10
San Antonio, Texas
Investigational Site 12
San Antonio, Texas
Investigational Site 17
San Antonio, Texas
Investigational Site 1
San Antonio, Texas
Investigational Site 20
San Antonio, Texas
Investigational Site 27
San Diego, California
Investigational Site 29
San Diego, California
Investigational Site 19
Skillman, New Jersey
Investigational Site 13
Spartanburg, South Carolina
Investigational Site 15
St Louis, Missouri
Investigational Site 11
Stockbridge, Georgia
Investigational Site 16
Sylvania, Ohio
Investigational Site 33
Tallahassee, Florida
Investigational Site 25
Waco, Texas
Investigational Site 8
Waco, Texas
About this study
Official title: A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- GSP 301 NS, GSP 301 Placebo NS pH 3.7, GSP 301 Placebo NS pH 7.0
- Medical subject headings
- Rhinitis, Allergic, Perennial
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 spray in each nostril twice daily for 52 weeks
GSP 301 Placebo NS pH 3.7Drug
2 spray in each nostril twice daily for 52 weeks
GSP 301 Placebo NS pH 7.0Drug
2 spray in each nostril twice daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| GSP 301 NS | Experimental | Not described Receives: Drug: GSP 301 NS |
| GSP 301 Placebo NS pH 3.7 | Placebo comparator | Not described Receives: Drug: GSP 301 Placebo NS pH 3.7 |
| GSP 301 Placebo NS pH 7.0 | Placebo comparator | Not described Receives: Drug: GSP 301 Placebo NS pH 7.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startApr 2016
- Primary completionJul 2017
- Study completionJul 2017
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 Perennial 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
- 601 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Specialty S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sudeesh Tantry, Study director, Glenmark Pharmaceuticals S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709538
- Sponsor's protocol ID
- GPL/CT/2014/018/III
- Acronym
- GSP 301-303
- Status last verified
- Feb 2020
- First submitted
- 11 Mar 2016
- Last updated
- 26 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Segall N, Prenner B, Lumry W, Caracta CF, Tantry SK. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019 Sep 1;40(5):301-310. doi: 10.2500/aap.2019.40.4233. Epub 2019 Jun 27.
PubMed 31248471
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
- ClinicalTrials.gov ID
- NCT02709538
- Acronym / sponsor ID
- GSP 301-303 / GPL/CT/2014/018/III
- Conditions
- Perennial Allergic Rhinitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 601 participants (actual)
- Lead sponsor
- Glenmark Specialty S.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GSP 301 NS | Experimental | Drug: GSP 301 NS |
| GSP 301 Placebo NS pH 3.7 | Placebo comparator | Drug: GSP 301 Placebo NS pH 3.7 |
| GSP 301 Placebo NS pH 7.0 | Placebo comparator | Drug: GSP 301 Placebo NS pH 7.0 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Aged ≥12 years and older inclusive of either sex.
- Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable.
Key exclusion criteria (6 listed)
- Pregnant or lactating women.
- 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.
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 spray in each nostril twice daily for 52 weeks | Drug | GSP 301 NS |
| GSP 301 Placebo NS pH 3.72 spray in each nostril twice daily for 52 weeks | Drug | GSP 301 Placebo NS pH 3.7 |
| GSP 301 Placebo NS pH 7.02 spray in each nostril twice daily for 52 weeks | Drug | GSP 301 Placebo NS pH 7.0 |
Primary outcome
Number of Participants With Treatment-emergent Adverse Events (TEAEs).
Time frame: 52 weeks
All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31248471Segall N, Prenner B, Lumry W, Caracta CF, Tantry SK. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019 Sep 1;40(5):301-310. doi: 10.2500/aap.2019.40.4233. Epub 2019 Jun 27.
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Perennial Allergic Rhinitis, Seasonal Allergic Rhinitis
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 study director
Glenmark Pharmaceuticals S.A.
34 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 Perennial Allergic Rhinitis, run by Glenmark Specialty S.A. at 34 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 2 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 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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 13 Sep 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?
Number of Participants With Treatment-emergent Adverse Events (TEAEs). (time frame: 52 weeks). 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 NCT02709538, 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 26 Feb 2020; AzTrials last refreshed its copy on 26 Oct 2026.