Nasya in Allergic Rhinitis

October 25, 2012 updated by: InQpharm Group

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline solution
Nasal spray
Device: Saline solution
Nasal spray, 2 sprays in each nostril
Experimental: Nasya
Thixotropic nasal spray suspension
Device: Nasya
Thixotropic nasal spray suspension, 2 sprays in each nostril

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in Total Nasal Symptom Score
Time Frame: 75 minutes
75 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in Total Nasal Symptom Score
Time Frame: Up to 240 minutes
Up to 240 minutes
Difference in Total Ocular Symptom Score
Time Frame: Up to 240 minutes
Up to 240 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InQpharm Group

Investigators

  • Principal Investigator: Minoo Lenarz, MD, Charite University, Berlin, Germany

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

December 27, 2011

First Submitted That Met QC Criteria

January 2, 2012

First Posted (Estimate)

January 4, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INQ/023411

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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