Nasya in Allergic Rhinitis

InQpharm Group20 enrolled

Overview

The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Allergic Rhinitis

Interventions

NasyaDEVICE

Thixotropic nasal spray suspension, 2 sprays in each nostril

Saline solutionDEVICE

Nasal spray, 2 sprays in each nostril

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

Inclusion Criteria: * History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years * Written informed consent Exclusion Criteria: * Clinically significant disease that could interfere with the evaluation of study medication * Participation in other studies within the last 4 weeks / during the study

Locations (1)

Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1

Berlin, State of Berlin, Germany

Outcomes

Primary Outcomes

Difference in Total Nasal Symptom Score

Time frame: 75 minutes

Secondary Outcomes

Difference in Total Nasal Symptom Score

Time frame: Up to 240 minutes

Difference in Total Ocular Symptom Score

Time frame: Up to 240 minutes

Data from ClinicalTrials.gov

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