Effect of Nasaleze on Nasal Challenge With Allergen

November 7, 2016 updated by: University of Chicago

Effect of Nasaleze on the Early Reaction to Nasal Challenge With Allergen

The objectives of this protocol are:

  1. to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and
  2. to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago

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 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Males and females between 18 and 45 years of age.
  2. History of grass and/or ragweed allergic rhinitis.
  3. Positive skin test to grass and/or ragweed antigen.
  4. Positive response to screening nasal challenge.

Exclusion Criteria:

  1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
  2. Pregnant or lactating women.
  3. Upper respiratory infection within 14 days of study start.
  4. FEV1<80% of predicted at screening for subjects with history of mild asthma.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Nasaleze spray
Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Drug: Nasaleze Spray
Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
Biological: Allergen
Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
Placebo Comparator: Placebo spray
Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge
Biological: Allergen
Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
Other: Placebo spray
Subjects are treated with placebo nasal spray then challenged with allergen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent
Time Frame: Day 2 after one week pretreatment with Nasaleze or placebo.
Change in total nasal symptom score after nasal challenges (the change is calculated as the total nasal symptom score after allergen challenge - total nasal symptom score after diluent challenge) on the second of two days of nasal challenges following one week of pretreatment with Nasaleze or placebo. The nasal symptoms included number of sneezes, symptoms of runny and stuffy nose (separately for each nostril), and itchy nose/throat symptoms. Individual symptoms were score on a scale from 0-3 (0=no symptoms, 1=mild, 2=moderate, 3=severe). The maximum total nasal symptom score possible was 15 with higher scores indicating worse symptoms.
Day 2 after one week pretreatment with Nasaleze or placebo.

Collaborators and Investigators

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

Sponsor

University of Chicago

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

November 1, 2012

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

November 5, 2012

First Submitted That Met QC Criteria

November 6, 2012

First Posted (Estimate)

November 7, 2012

Study Record Updates

Last Update Posted (Estimate)

January 2, 2017

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-1252

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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