Back to resultsTopical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ASP-1001 nasal spray
Placebo for ASP-1001
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
Inclusion Criteria:
- Males and females between 18 and 55 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 or sinusitis within 14 days of study start.
- Use of nasal steroids, antihistamines in the last 2 weeks.
- FEV1<80% of predicted at screening for subjects with history of mild asthma
- current smokers or recent ex-smokers
- 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 Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
1
2
Arm Description
Topical ASP-1001
Placebo for Topical ASP-1001
Outcomes
Primary Outcome Measures
Change in Sneezing Symptom
Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Change in Runny Nose Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Change in Stuffy Nose Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Change in Itching Symptom
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
Secondary Outcome Measures
Nasal Peak Inspiratory Flow Measurements
The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
Full Information
NCT ID
NCT00791102
First Posted
November 13, 2008
Last Updated
July 8, 2013
Sponsor
University of Chicago
Collaborators
Asphelia Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00791102
Brief Title
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical ASP-1001 (Contrast Media Formulation) in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (NAC)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chicago
Collaborators
Asphelia Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to see whether ASP-1001 when given as a nasal spray is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever) following nasal challenge with antigen.
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 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Topical ASP-1001
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo for Topical ASP-1001
Intervention Type
Drug
Intervention Name(s)
ASP-1001 nasal spray
Intervention Description
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Intervention Type
Drug
Intervention Name(s)
Placebo for ASP-1001
Intervention Description
2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge.
Primary Outcome Measure Information:
Title
Change in Sneezing Symptom
Description
Sneezes. The change is calculated by adding the number of sneezes following both antigen challenges minus twice the number of sneezes after the diluent challenge.
Time Frame
10 minutes after diluent challenge and 10 minutes after each antigen challenge
Title
Change in Runny Nose Symptom
Description
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of runny nose following both antigen challenges minus twice the score of runny nose after the diluent challenge.
Time Frame
10 minutes after diluent challenge and 10 minutes after each antigen challenge
Title
Change in Stuffy Nose Symptom
Description
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of stuffy nose following both antigen challenges minus twice the score of stuffy nose after the diluent challenge.
Time Frame
10 minutes after diluent challenge and 10 minutes after each antigen challenge
Title
Change in Itching Symptom
Description
The nasal symptoms on a scale of 0-3 (0=no symptoms, 1=mild, 2= moderate, 3= severe). The change is calculated by adding the score of itchy nose following both antigen challenges minus twice the score of itchy nose after the diluent challenge.
Time Frame
10 minutes after diluent challenge and 10 minutes after each antigen challenge
Secondary Outcome Measure Information:
Title
Nasal Peak Inspiratory Flow Measurements
Description
The value of nasal peak inspiratory flow. The change is calculated by adding the values of nasal peak inspiratory flow following both antigen challenges minus twice the value of nasal peak inspiratory flow after the diluent challenge.
Time Frame
15 minutes after diluent challenge and 15 minutes after each antigen challenge
Title
Change in Nasal Peak Inspiratory Flow Measurements From Before to After Treatment
Time Frame
15 minutes prior to treatment and 15 minutes post antigen challenges
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Days
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Males and females between 18 and 55 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 or sinusitis within 14 days of study start.
Use of nasal steroids, antihistamines in the last 2 weeks.
FEV1<80% of predicted at screening for subjects with history of mild asthma
current smokers or recent ex-smokers
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 Naclerio, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Topical ASP-1001 (Contrast Media Formulation) and the Acute Response to Nasal Allergen Challenge (NAC)
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