Finding studies
Finding studies
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Lead
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
With
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.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
