Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Rhinitis, Allergic, Seasonal

In brief

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, and each of three study visits during that time will last a few hours. Subjects will be required to have several tests done including allergy and breathing tests. They will be exposed to the item they are allergic to and will have small paper discs put in their noses. Subjects will also have the inside of their noses examined and will be asked questions about the level of their allergy symptoms.

Key facts

Study ID

NCT01500629

Run by

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.

People needed

21

Starts

2012-01-01

Expected to finish

2012-12-01

Last updated by the study team

2017-02-27

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• The University of Chicago — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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