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Effect of Nasaleze on Nasal Challenge With Allergen

Primary Purpose

Allergic Rhinitis

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Nasaleze Spray

Placebo spray

Allergen

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria:

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

Sites / Locations

University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nasaleze spray

Placebo spray

Arm Description

Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Outcomes

Primary Outcome Measures

Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01723397

First Posted

November 5, 2012

Last Updated

November 7, 2016

Sponsor

University of Chicago

1. Study Identification

Unique Protocol Identification Number

NCT01723397

Brief Title

Effect of Nasaleze on Nasal Challenge With Allergen

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Terminated

Why Stopped

Poor recruitment

Study Start Date

November 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Chicago

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The objectives of this protocol are: to confirm the inhibitory effect of Nasaleze on the immediate response to nasal challenge with antigen, and to show that inhibition of the immediate response to nasal challenge with antigen by Nasaleze inhibits subsequent inflammatory events.

6. Conditions and Keywords

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

Allergic Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

14 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Nasaleze spray

Arm Type

Active Comparator

Arm Description

Nasaleze spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Arm Title

Placebo spray

Arm Type

Placebo Comparator

Arm Description

Placebo spray 1 puff via "spray device" in each nostril 3 times daily for 1 week followed by allergen challenge

Intervention Type

Drug

Intervention Name(s)

Nasaleze Spray

Intervention Description

Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen

Intervention Type

Other

Intervention Name(s)

Placebo spray

Intervention Description

Subjects are treated with placebo nasal spray then challenged with allergen

Intervention Type

Biological

Intervention Name(s)

Allergen

Intervention Description

Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo

Primary Outcome Measure Information:

Title

Change in Total Nasal Symptom Score After Nasal Challenge With Allergen Versus Diluent

Description

Time Frame

Day 2 after one week pretreatment with Nasaleze or placebo.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Males and females between 18 and 45 years of age. History of grass and/or ragweed allergic rhinitis. Positive skin test to grass and/or ragweed antigen. Positive response to screening nasal challenge. Exclusion Criteria: Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. Pregnant or lactating women. Upper respiratory infection within 14 days of study start. FEV1<80% of predicted at screening for subjects with history of mild asthma.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert M Naclerio, MD

Organizational Affiliation

University of Chicago

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

12. IPD Sharing Statement

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Effect of Nasaleze on Nasal Challenge With Allergen

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