Study of a Topical Nasal Spray to Ease the Symptoms of Hayfever
Condition: Rhinitis, Allergic, Seasonal
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Early Phase 1

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, 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.
    

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 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.
    

Intervention name(s): C-1266-7; C-1266-6 (placebo)
Intervention type(s): Device; Device
Intervention description(s): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.; Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.
Other intervention name(s): Not yet marketed; Not yet marketed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Allergic Rhinitis; Hayfever; Pollen Allergy