Status:
WITHDRAWN
Topical Allstate and Nasal Allergen Challenge
Lead Sponsor:
University of Chicago
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
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).
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01231724
Start Date
November 1 2011
End Date
April 1 2012
Last Update
June 3 2013
Active Locations (1)
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1
University of Chicago
Chicago, Illinois, United States, 60637