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:
- Received systemic corticosteroids or other systemic immunosuppressants over ~50% or more of the prior 12 months.
- Uncontrolled on asthma treatment consistent with the GINA Step 4 or 5, receiving high-dose ICS with additional controllers.
- 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.
- ≥18 years
- ≥12 months diagnosis of severe asthma
- Meet study criteria for severe asthma treatment
- 4000 patients enrolled across multiple academic and community-based specialist centres by asthma treating specialists (e.g., allergists and pulmonologists).
- 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.
- 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