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Topical Allstate and Nasal Allergen Challenge

Primary Purpose

Allergic Rhinitis

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Allstate Nasal Spray
Placebo Nasal Spray
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

  1. Males and females between 18 and 55 years of age.
  2. History of grass and/or ragweed allergic rhinitis for at least 2 years.
  3. Positive skin test to grass and/or ragweed antigen within prior 12 months.
  4. Positive response to screening nasal challenge.

Exclusion Criteria

  1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
  2. Use of nasal steroids, antihistamines in the last 2 weeks.
  3. Upper respiratory infection, sinusitis less than 2 weeks before screening.
  4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
  5. Having poorly tolerated previous administration of allergens
  6. Nasolacrimal drainage system malfunctions.
  7. Participation in other investigational therapy in the last 30 days.
  8. Any systemic disorder or medication interfering with the study.
  9. FEV1<80% of predicted at screening for subjects with mild asthma.
  10. Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline)
  11. Undergoing allergen desensitization therapy.
  12. Current smokers or recent ex-smokers.
  13. Not willing to give informed consent
  14. Inability to understand the nature and requirements of the study, or to comply with the study procedures.
  15. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allstate Nasal Spray

Placebo Nasal Spray

Arm Description

Outcomes

Primary Outcome Measures

Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.

Secondary Outcome Measures

Full Information

First Posted
October 28, 2010
Last Updated
May 30, 2013
Sponsor
University of Chicago
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01231724
Brief Title
Topical Allstate and Nasal Allergen Challenge
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Withdrawn
Why Stopped
study halted prematurely, prior to enrollment of first participant
Study Start Date
November 2011 (undefined)
Primary Completion Date
February 2012 (Anticipated)
Study Completion Date
April 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chicago
Collaborators
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).

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
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Allstate Nasal Spray
Arm Type
Active Comparator
Arm Title
Placebo Nasal Spray
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
Allstate Nasal Spray
Intervention Description
Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.
Intervention Type
Device
Intervention Name(s)
Placebo Nasal Spray
Intervention Description
2 sprays in each nostril
Primary Outcome Measure Information:
Title
Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.
Time Frame
10 minutes following each nasal challenge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Males and females between 18 and 55 years of age. History of grass and/or ragweed allergic rhinitis for at least 2 years. Positive skin test to grass and/or ragweed antigen within prior 12 months. Positive response to screening nasal challenge. Exclusion Criteria Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma. Use of nasal steroids, antihistamines in the last 2 weeks. Upper respiratory infection, sinusitis less than 2 weeks before screening. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days). Having poorly tolerated previous administration of allergens Nasolacrimal drainage system malfunctions. Participation in other investigational therapy in the last 30 days. Any systemic disorder or medication interfering with the study. FEV1<80% of predicted at screening for subjects with mild asthma. Presence of allergic rhinitis symptoms in the screening period with TNSS >3 at baseline) Undergoing allergen desensitization therapy. Current smokers or recent ex-smokers. Not willing to give informed consent Inability to understand the nature and requirements of the study, or to comply with the study procedures. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
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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Topical Allstate and Nasal Allergen Challenge

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