Study Evaluating Nasal Symptoms Induced by a Nasal Allergen Challenge (NAC) To House Dust Mite Allergen

October 21, 2015 updated by: ORA, Inc.

A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen Challenge (NAC) in a Dust Mite Population

Study Overview

Status

Completed

Conditions

Allergic Rhinitis

Study Type

Observational

Enrollment (Actual)

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

United States
- Massachusetts
  - Andover, Massachusetts, United States, 01810
    - Ora Clinical Research Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

subjects at least 18 years of age of either sex and any race

Description

Inclusion Criteria:

be at least 18 years of age
positive ST to Dust Mite
history of allergic rhinitis

Exclusion Criteria:

no active infections
no disallowed medications
no nasal anatomical deformities or nasal surgical interventions in the past

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
TNSS= total nasal symptoms score Time Frame: 15 minutes	15 minutes

Secondary Outcome Measures

Outcome Measure	Time Frame
Individual nasal symptoms Time Frame: 15 minutes	15 minutes

Collaborators and Investigators

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

Sponsor

ORA, Inc.

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

August 1, 2013

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria