PILOT STUDY OF THE EFFICACY AND SAFETY OF WF10 IN SUBJECTS SUFFERING FROM PERSISTENT ALLERGIC RHINITIS
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
Objectives To assess the efficacy and safety of WF10 infusions in the treatment of subjects
with persistent allergic rhinitis.
Study Design Randomized, double-blind, placebo-controlled, parallel-group, single-centre
trial.
Subjects 50 subjects (25 per treatment group) with history of persistent allergic rhinitis
for at least 2 years prior to enrolment and a positive allergen skin test. Subjects will be
required to have a minimum mean score ≥6 for the baseline Total Nasal Symptom Score (TNSS)
(mean score of morning and evening reflective TNSS assessments for the 3 days prior to
randomization and treatment.
Treatments At the first treatment visit (T1), subjects that comply with the inclusion and
exclusion criteria will be randomized into one of two treatment groups: WF10, or placebo.
Each individual treatment dose of study drug solution is 0.5 mL/kg body weight, diluted into
500 mL saline solution. Treatment will be administered once daily for 5 consecutive days
(Visits T1-T5) via intravenous infusion.