Late Phase Administration Anakinra as a Rescue Treatment for Inhaled Allergen Challenge-Induced Airway Inflammation
Status:
Withdrawn
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
Purpose: The primary objective of this study is to examine the effectiveness of anakinra as a
rescue treatment for allergic airway inflammation. Utilizing an inhaled allergen challenge
model, the investigators will determine the effectiveness of a single 1 mg/kg dose of
anakinra administered after inhaled allergen challenge for mitigating features of airway
inflammation.
Participants: 25 mild allergic asthmatics sensitized to Dermatophagoides farinae (D. farinae)
Procedures (methods): 12 eligible subjects of 25 volunteers will participate in a double
blind cross-over study. Following randomization to the placebo or anakinra treatment group,
subjects will undergo inhalation of D. farinae, and their early and late phase asthmatic
responses will be measured. Subjects will undergo induced sputum sampling, methacholine
challenge, and mucociliary clearance measures. After completion of period 1, subjects will
cross over to the alternate study arm.