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Nasya in Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status

Completed

Phase

Phase 3

Locations

Germany

Study Type

Interventional

Intervention

Nasya

Saline solution

About this trial

This is an interventional prevention trial for Allergic Rhinitis focused on measuring Allergic rhinitis, Allergen, Allergy, Dustmite

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Saline solution

Nasya

Arm Description

Nasal spray

Thixotropic nasal spray suspension

Outcomes

Primary Outcome Measures

Difference in Total Nasal Symptom Score

Secondary Outcome Measures

Difference in Total Nasal Symptom Score

Difference in Total Ocular Symptom Score

Full Information

NCT ID

NCT01503957

First Posted

December 27, 2011

Last Updated

October 25, 2012

Sponsor

InQpharm Group

1. Study Identification

Unique Protocol Identification Number

NCT01503957

Brief Title

Nasya in Allergic Rhinitis

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2012

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

September 2012 (Actual)

Study Completion Date

September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

InQpharm Group

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis

Keywords

Allergic rhinitis, Allergen, Allergy, Dustmite

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saline solution

Arm Type

Placebo Comparator

Arm Description

Nasal spray

Arm Title

Nasya

Arm Type

Experimental

Arm Description

Thixotropic nasal spray suspension

Intervention Type

Device

Intervention Name(s)

Nasya

Intervention Description

Thixotropic nasal spray suspension, 2 sprays in each nostril

Intervention Type

Device

Intervention Name(s)

Saline solution

Intervention Description

Nasal spray, 2 sprays in each nostril

Primary Outcome Measure Information:

Title

Difference in Total Nasal Symptom Score

Time Frame

75 minutes

Secondary Outcome Measure Information:

Title

Difference in Total Nasal Symptom Score

Time Frame

Up to 240 minutes

Title

Difference in Total Ocular Symptom Score

Time Frame

Up to 240 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Minoo Lenarz, MD

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

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Nasya in Allergic Rhinitis

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