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Nasya in Allergic Rhinitis

NCT ID: NCT01503957

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis

Keywords

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Allergic rhinitis Allergen Allergy Dustmite

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Saline solution

Nasal spray

Group Type PLACEBO_COMPARATOR

Saline solution

Intervention Type DEVICE

Nasal spray, 2 sprays in each nostril

Nasya

Thixotropic nasal spray suspension

Group Type EXPERIMENTAL

Nasya

Intervention Type DEVICE

Thixotropic nasal spray suspension, 2 sprays in each nostril

Interventions

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Nasya

Thixotropic nasal spray suspension, 2 sprays in each nostril

Intervention Type DEVICE

Saline solution

Nasal spray, 2 sprays in each nostril

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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InQpharm Group

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Minoo Lenarz, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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INQ/023411

Identifier Type: -

Identifier Source: org_study_id