Overview

Early Phase Administration of 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Withdrawn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: 12 mild allergic asthmatics sensitized to Dermatophagoides farinae (D. farinae) Procedures (methods): Eligible subjects 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Treatments:
Interleukin 1 Receptor Antagonist Protein