Nasya in Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01503957
• Other study ID #: INQ/023411
• Status: Completed
• Phase: Phase 3
• First received: December 27, 2011
• Last updated: October 25, 2012
• Start date: January 2012
• Est. completion date: September 2012

Study information

• Verified date: October 2012
• Source: InQpharm Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Device:
• Nasya
Thixotropic nasal spray suspension, 2 sprays in each nostril
• Saline solution
Nasal spray, 2 sprays in each nostril

Locations

Country	Name	City	State
Germany	Campus Charite´ Mitte Klinik und Poliklinik fu¨r Hals-, Nasen-, Ohren- heilkunde Charite´ - Universita¨tsmedizin Berlin, Charite´platz 1	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
InQpharm Group

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Total Nasal Symptom Score		75 minutes	No
Secondary	Difference in Total Nasal Symptom Score		Up to 240 minutes	No
Secondary	Difference in Total Ocular Symptom Score		Up to 240 minutes	No