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coreASTHMA | Core Outcome Set for Moderate to Severe Asthma

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Asthma is a disease of chronic airway inflammation, with multiple symptoms such as coughing, wheezing, and shortness of breath impacting patients’ daily functioning and quality of life. Despite multiple treatment options for management of asthma, patients with severe or poorly controlled asthma still fail to improve with existing treatments. With recent innovations in immunotherapy, new biologic drugs give hope for long-term control of asthma, particularly in patients who have had limited success with traditional therapies.  However, these new therapies come with high price tags and more questions.

The goal is to apply our multi-stakeholder consensus methodology for developing core outcome sets to establish a core outcome set for pivotal or late phase clinical trials of therapies for  moderate to severe asthma, with particular focus on determining a subset of quality-of-life and symptom burden parameters that are patient-important, clinically meaningful to payers, and relevant to guideline-directed steps of treatment escalation to biologics for asthma care.

Clinicians, patients, regulatory agencies, payers, health technology assessors, and researchers will be engaged in three rounds of a modified Delphi process to help identify and understand important outcomes to be used in phase three or late phase clinical trials for moderate to severe asthma. They will also attend an in-person meeting to discuss outcomes in more detail while sharing perceptions and opinions about the importance of some outcomes.

Thank you to our sponsors:

Chiesi

GPC is carrying out this initiative in partnership with Allergy and Asthma Network (AAN). If you are interested in being involved in coreASTHMA, please contact Jen Al Naber.

ASTHMA timeline

This project is in progress, and results are expected to be reported around June 2020. Stay tuned!