Observational Study of Characteristics, Treatment and Outcomes With Severe Asthma in the United States (CHRONICLE)

Korábbi kezelés

• Inability to complete study follow-up or web-based PROs. If the patient does not have email or web access, minimal assistance from others to access the web-based PRO is permitted (ie receiving the email and/or assisting patient in navigating to the web page); PROs must be completed by the patient.
• Received an investigational therapy for asthma, allergy, atopic disease, or eosinophilic disease as part of a clinical trial during the 6 months prior to enrollment.
  • Once enrolled in the CHRONICLE Study, patients can enroll in trials of investigational therapies (as well as other non-interventional studies) as long as they continue to complete study follow-up. If a patient enrolls in a trial of an investigational therapy, the identity (National Clinical Trial \[NCT\] number) of the study and dates of the first and last investigational therapy administrations will be collected. If a patient receives blinded therapy in a trial, the Investigator will request the identity of that therapy at trial conclusion so that treatment information collected for the current study may be updated accordingly.

Egyéb

• Not willing and able to sign written informed consent. Consent can be obtained from having a responsible, legally authorized representative acting on patient's behalf.
• Not fluent in English or Spanish.

• 1\. Individuals with a diagnosis of severe asthma for at least 12 months prior to enrollment and confirmed by the Investigator not to be due to alternative diagnoses.
• 2\. Currently receiving care from specialist physicians (eg, pulmonologists and or allergists) at the Investigator's or sub-investigator's site.
• 3\. 18 years of age and older. 4. Meeting at least one of the following three criteria (a, b, or c):
• Uncontrolled asthma while receiving high-dose ICS with additional controllers.
• Uncontrolled is defined by meeting at least one of the following (as outlined by ATS/ERS \[American Thoracic Society/European Respiratory Society\] guidelines):
• Poor symptom control: Asthma Control Questionnaire consistently ≥1.5, ACT \<20 (or "not well controlled" by NAEPP \[National Asthma Education and Prevention Program\]/Global Initiative for Asthma guidelines).
• Frequent severe exacerbations: two or more bursts of systemic corticosteroids (≥3 days each) in the previous 12 months.
• Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous 12 months.
• Airflow limitation: after appropriate bronchodilator withhold FEV1 \<80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal).
• For the purposes of this study, high-dose ICS will be defined as
  • 1\. ICS at a cumulative dose of \>500 μg fluticasone propionate equivalents daily as defined in Appendix A, or 2. Highest labeled dose of a combination of ICS/LABA. b. Current use of a Food and Drug Administration (FDA)-approved monoclonal antibody agent for treatment of severe asthma (use is not primarily for an alternative condition).
• Use of systemic corticosteroids or other systemic immunosuppressants (any dose level) for approximately 50% or more of the prior 12 months for treatment of severe asthma (use is not primarily for an alternative condition).