Status:
COMPLETED
Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever
Lead Sponsor:
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
Collaborating Sponsors:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Rhinitis, Allergic, Seasonal
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this study is to see if a new nasal spray can reduce the signs and symptoms of allergic rhinitis (hayfever). Subjects' participation in the study will last approximately 4 to 6 weeks, a...
Detailed Description
This study is a randomized, double blind, placebo-controlled, 2-way cross over trial. Approximately 25 subjects with a history of seasonal grass and/or ragweed allergy symptoms will be enrolled in the...
Eligibility Criteria
Inclusion
- History of grass and/or ragweed allergic rhinitis for at least 2 years prior to screening
- Positive skin test to grass and/or ragweed antigen within 12 months prior to screening
- Being asymptomatic of nasal symptoms (i.e., sneezing, itchy nose, runny nose, and nasal congestion) for at least 2 weeks prior to screening.
- Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to screening and agree to continue using it during participation in the study (abstinence is not an approved method).
Exclusion
- Participation in another investigational therapy 30 days prior to screening
- Not willing to give informed consent
- Inability to understand the nature and requirements of the study, or to comply with the study procedures
- Use of antihistamines within 1 week prior to screening (or during study visits)
- History of respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
- Current smoker or recent ex-smoker defined as history of smoking or use of nicotine containing substances within 2 months prior to screening as determined by medical history or subjects verbal report.
- Other severe acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01500629
Start Date
January 1 2012
End Date
December 1 2012
Last Update
February 27 2017
Active Locations (1)
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1
The University of Chicago
Chicago, Illinois, United States, 60637