Phase 3
Completed 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
Source: ClinicalTrials.gov NCT02709538 ↗
Enrolled (actual)
601
Serious AEs
1.8%
Results posted
Sep 2018
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs). — 203; 41; 54 participants
◆ Published Evidence
Established
36citations · ~5 / year
Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis.
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)
Linked Publications
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Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs). |
203; 41; 54 | — |
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) and the linked publication. 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. Informational only — not medical advice.