Phase 3
Completed N=1,180
Efficacy and Safety of Fixed Dose Combination GSP 301 Nasal Spray (NS) in the Treatment of Seasonal Allergic Rhinitis (SAR)
Source: ClinicalTrials.gov NCT02631551 ↗Enrolled (actual)
1,180
Serious AEs
0.1%
Results posted
Aug 2018
Primary outcomePrimary: Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. — 10.1; 10.3; 10.2; 10.2 units on a scale — p=<0.0001
◆ Published Evidence
Established
43citations · ~6 / year
Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis.
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
Linked Publications
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Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. |
10.1; 10.3; 10.2; 10.2; -3.6; -3.2 | <0.0001 sig |
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02631551) 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.