Phase 3
Completed N=446
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
Seasonal Allergic Rhinitis (SAR)
Source: ClinicalTrials.gov NCT03463031 ↗
Enrolled (actual)
446
Serious AEs
0.2%
Results posted
Oct 2019
Primary outcomePrimary: Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period — 8.83; 8.84; -2.2; -1.6 units on a scale — p=0.001
◆ Published Evidence
Emerging
15citations · ~4 / year
Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis.
Summary
Study to evaluate the efficacy, safety and tolerability of GSP 301 nasal spray (NS) compared with placebo NS in pediatric subjects (aged 6 to under 12 years) with Seasonal Allergic Rhinitis (SAR).
Linked Publications
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Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score ( rTNSS) Over the 14-day Treatment Period |
8.83; 8.84; -2.2; -1.6 | 0.001 sig |
| SECONDARY Change From Baseline in Average AM and PM Subject-reported 12-hour Instantaneous Total Nasal Symptom Score (iTNSS) Over the 14-day Treatment Period. |
7.89; 7.82; -1.8; -1.1 | <0.001 sig |
| SECONDARY Change From Baseline in the Overall Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Score on Day 15 (Visit 4) |
2.51; 2.42; -0.8; -0.5 | < 0.001 sig |
| SECONDARY Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Ocular Symptom Score (rTOSS) Over the 14-day Treatment Period. |
3.84; 3.59; -0.8; -0.6 | 0.233 |
Eligibility Criteria
Inclusion Criteria
- Male and female subjects aged ≥6 to <12 years
- Clinical history of SAR (at least 2 years) with exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen)
- Demonstrated sensitivity to at least 1 seasonal allergen through positive skin prick test within 12 months prior to screening
- A 12-hour rTNSS value ≥6 out of a possible 12 for the morning assessment at screening
- Signed informed consent/assent form (subject and parent/caregiver/legal guardian)
Exclusion Criteria
- Females of childbearing potential or pregnant
- Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period.
- History of anaphylaxis and/or other severe local reaction(s) to skin testing
- History and evidence of acute or significant chronic sinusitis or chronic purulent post nasal drip
- Subjects with an active pulmonary disorder or infection.
- Subjects with posterior subcapsular cataracts or glaucoma
Data sourced from ClinicalTrials.gov (NCT03463031) 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.