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AstraZeneca’s Respiratory & Immunology medical resource centre for healthcare professionals

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What is the CHRONICLE Study?

The CHRONICLE study is a long-term prospective observational study of disease characteristics, treatment patterns and health outcomes in individuals with severe asthma who do not achieve control with high-dose inhaled corticosteroid (ICS) therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy.

 

The study, sponsored by AstraZeneca, aims to provide a contemporary view of the epidemiology and management of severe asthma in the United States. Patients (≥18 years old; ≥12 months diagnosis of severe asthma) will meet one of the three following treatment criteria for severe asthma:

  1. Received systemic corticosteroids or other systemic immunosuppressants over ~50% or more of the prior 12 months.
  2. Uncontrolled on asthma treatment consistent with the GINA Step 4 or 5, receiving high-dose ICS with additional controllers.
  3. Current use of an FDA-approved monoclonal antibody agent for treatment of severe asthma.

 

If you would like more information on the CHRONICLE study, contact the AstraZeneca Information Center or take a look at the AstraZeneca clinical trials website.

Study Design

Patients:

  • ≥18 years
  • ≥12 months diagnosis of severe asthma
  • Meet study criteria for severe asthma treatment

 

Enrolling:

  • 4000 patients enrolled across multiple academic and community-based specialist centres by asthma treating specialists (e.g., allergists and pulmonologists).

 

Collection:

  • Information from medical records and specialists at baseline and every 6 months
  • Patient completed web-based disease characteristics and quality of life patient surveys at baseline, monthly, every 3 months and every 6 months depending on the specific endpoint.

 

Completion:

  • Patients will be followed until study discontinuation, patient withdrawal or death, whichever occurs first (expected to be at least 3 years).

 

ClinicalTrials.gov Identifier: NCT03373045

Recruitment status: Recruiting

https://clinicaltrials.gov/ct2/show/NCT03373045

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