This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR).
PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining.
This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days.
The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.
Clinical history of seasonal AR, as reported by the subject, with symptoms for more than two years and exacerbations during the study season for the relevant seasonal allergen (e.g., tree/grass pollen/ragweed).
Positive skin prick test (i.e., wheal ≥3 mm larger than the diluent control with erythema) or positive in vitro tests for specific IgE against allergen(s) relevant to the enrollment period at Baseline or within 12 months before enrollment .
Age ≥ 18 years and ≤ 75 years at Screening.
Active symptoms of seasonal AR with an rTNSS score ≥5 at randomization (based on the average rTNSS score during the Run-in Period and rounded to the nearest whole number).
1. Presence of active, moderate or severe symptoms of non-allergic rhinitis , acute inflammation of the nose, or paranasal sinusitis at Screening or within the 7 days prior.
Nasal septal deviation associated with clinically significant nasal obstruction, as determined by the investigator based on physical examination, and resulting in functional impairment (e.g., patient-reported difficulty in airflow).
Nasal polyps
Chronic rhinosinusitis (with or without nasal polyposis)
Parallel
PL-14 Allergy Blocker
DevicePL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act as a mechanical barrier in the nasal cavity to reduce contact between inhaled allergens and the nasal mucosa.
Ayr® Saline Nasal Mist
DeviceAyr® Saline Nasal Mist is a non-medicated isotonic saline nasal spray used as the control comparator in this study.
Difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between treatment groups
Assessment of the difference in mean daily reflective Total Nasal Symptom Score (rTNSS) between PL-14 Allergy Blocker and Ayr® Saline Nasal Mist during the first 14 treatment days. The rTNSS is the sum of four nasal symptom scores (rhinorrhea, nasal congestion, nasal itching and sneezing), each rated on a 0-3 scale (0 = none, 3 = severe), for a total score range of 0-12. Higher scores indicate more severe symptoms (worse outcome).
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