Phase 3
N=601
Long Term Safety and Efficacy of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Perennial Allergic Rhinitis (PAR)
Perennial Allergic Rhinitis
Bottom Line
View on ClinicalTrials.gov: NCT02709538 ↗Enrolled (actual)
601
Serious AEs
1.8%
Results posted
Sep 2018
Primary outcome: Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs). — 203; 41; 54 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- GSP 301 NS (Drug); GSP 301 Placebo NS pH 3.7 (Drug); GSP 301 Placebo NS pH 7.0 (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Glenmark Specialty S.A.
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs). |
203; 41; 54 | — |
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)
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02709538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.