Nasya in Allergic Rhinitis

Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01503957

Enrollment

Registered

2012-01-04

Start date

2012-01-31

Completion date

2012-09-30

Last updated

2012-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitis, Allergen, Allergy, Dustmite

Brief summary

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.

Interventions

DEVICENasya

Thixotropic nasal spray suspension, 2 sprays in each nostril

DEVICESaline solution

Nasal spray, 2 sprays in each nostril

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Difference in Total Nasal Symptom Score	75 minutes

Secondary

Measure	Time frame
Difference in Total Nasal Symptom Score	Up to 240 minutes
Difference in Total Ocular Symptom Score	Up to 240 minutes

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026