Nasya in Allergic Rhinitis

Phase 3

Completed

• Conditions: Allergic Rhinitis
• Interventions: Device: Saline solution; Device: Nasya

• Registration Number: NCT01503957
• Lead Sponsor: InQpharm Group

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-12-27
• Study Start: 2012-01
• Study First Submitted QC: 2012-01-02
• Study First Posted: 2012-01-04
• Primary Completion: 2012-09
• Study Completion: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline solution	Saline solution	Nasal spray
Nasya	Nasya	Thixotropic nasal spray suspension

Primary Outcome Measures

Name	Time	Method
Difference in Total Nasal Symptom Score	75 minutes

Secondary Outcome Measures

Name	Time	Method
Difference in Total Nasal Symptom Score	Up to 240 minutes
Difference in Total Ocular Symptom Score	Up to 240 minutes

Trial Locations

Locations (1)

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