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
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