Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Aerovance, Inc.
With
Objectives: Primary Objective * To investigate the late asthmatic response in mild to moderate asthmatics.. Secondary Objectives * To examine the effects of AER 001 on cutaneous antigen response, antigen induced airway hyperactivity and sputum eosinophilia. Methodology: Study Design: * Single centre, phase IIa, double-blind, randomised, parallel group, repeated dose study in male and female asthmatic subjects. * A sufficient number of subjects (at least 24 subjects) will be recruited to ensure that at least 20 completed sets of data will be obtained. * Subjects will be randomised to receive either AER 001 25 mg / Placebo in a ratio of 1 active : 1 placebo. * Treatments will be administered as a sub-cutaneous injection. * Subjects are to receive a daily administration of AER 001 / placebo over a 4 week period. * Subjects will be admitted to the unit at least 2 hours prior to the first dose administration. On the first dosing occasion the subjects will remain in the unit under clinical supervision for at least 30 minutes post dose or until the Investigator is satisfied for them to be discharged. On subsequent dosing days the subjects will be admitted to the unit at least 45 minutes prior to dosing and remain in the unit for at least 15 minutes post dose or until the Investigator is satisfied for them to be discharged.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
