Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever
Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever
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.
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 study to ensure 20 complete the study.

 Subjects will be randomized to one of two treatment sequences of experimental product
 (investigational nasal spray) and placebo (sham nasal spray). Subjects will be asymptomatic
 of nasal symptoms (i.e., sneezing, itchy nose, runny nose, and nasal congestion) for at least
 2 weeks prior to screening, and at least 1 week after the latest use of concomitant
 medication for symptom control in order to be eligible to participate in this study. Any
 subject with a history of mild asthma will be required to undergo a Forced Expiratory Volume
 in 1 second (FEV1) test prior to each nasal challenge (diluent and allergen) throughout the
 study. Assessments will be completed pre- and post-diluent challenge and post-allergen
 challenge. The baseline assessment for symptom scores is defined as the assessment obtained
 after the diluent challenge but prior (-15 minutes prior to randomization) to the
 administration of the experimental product/sham control.

 Using a 14-day wash out period (± 2days), subjects who continue to meet inclusion criteria
 will receive treatments according to their randomized sequence. Eligible allergic subjects
 will undergo nasal challenges with either grass or ragweed allergen outside their allergy
 season.

 Severity of symptoms will be assessed by the subject on a scale of 0=no symptoms to 3=severe.
 Adverse events will be collected during each visit, as well as the day following each visit
 via telephone.
Inclusion Criteria:

 -  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 Criteria:

 -  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.