Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis
brief summary
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.
detailed description
Seasonal Allergic Rhinitis (SAR) is a common chronic condition associated with symptoms such as sneezing, rhinorrhea, nasal congestion, and nasal itching triggered by exposure to airborne allergens. PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to act purely as a mechanical barrier in the nasal cavity, significantly reducing contact between inhaled allergens and the nasal mucosa. PL-14 Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting the alleviation of mild allergic symptoms, including itchy, runny, or congested nasal passages, triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs, and dust mites. PL-14 Allergy Blocker functions by forming a non-specific, soft gel-like physical barrier on the nasal mucosa through the rheological and mucoadhesive properties of its primary components, sodium alginate and carrageenan. Upon application, PL-14 Allergy Blocker facilitates the formation of a continuous film that adheres to the nasal cavity and entraps inhaled particles, thereby reducing exposure of the nasal epithelium to airborne allergens. This study is a prospective, randomized, single-blind, saline-controlled, parallel-group, multi-center clinical investigation evaluating the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to Ayr® Saline Nasal Mist in adults with Seasonal Allergic Rhinitis. Up to 120 participants will be enrolled at up to 8 investigational sites in the United States. Eligible participants will undergo a treatment-free run-in period followed by randomization in a 1:1 ratio to either PL-14 Allergy Blocker or saline spray. Participants will self-administer the assigned study product for up to 30 days. Efficacy assessments will primarily focus on the first 14 treatment days and will include reflective and instantaneous Total Nasal Symptom Scores (rTNSS/iTNSS), quality of life assessments using the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), rescue medication use, and symptom-free days. Safety assessments will include adverse events monitoring, local nasal tolerability evaluations, nasal examinations, concomitant medication assessments, and investigator and participant global tolerability assessments throughout the study period. The total participation duration for each subject will be approximately 37 days, including screening, treatment, and follow-up.