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

Recruiting

• Conditions: Asthma

• Registration Number: NCT03373045
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-11-20
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Individuals with a diagnosis of severe asthma for at least 12 months prior to<br> enrollment and confirmed by the Investigator not to be due to alternative diagnoses.<br><br> 2. Currently receiving care from specialist physicians (eg, pulmonologists and or<br> allergists) at the Investigator's or sub-investigator's site.<br><br> 3. 18 years of age and older. 4. Meeting at least one of the following three criteria<br> (a, b, or c):<br><br>a. Uncontrolled asthma while receiving high-dose ICS with additional controllers.<br><br>i. Uncontrolled is defined by meeting at least one of the following (as outlined by<br>ATS/ERS [American Thoracic Society/European Respiratory Society] guidelines):<br><br> 1. Poor symptom control: Asthma Control Questionnaire consistently =1.5, ACT <20 (or<br> not well controlled by NAEPP [National Asthma Education and Prevention<br> Program]/Global Initiative for Asthma guidelines).<br><br> 2. Frequent severe exacerbations: two or more bursts of systemic corticosteroids (=3<br> days each) in the previous 12 months.<br><br> 3. Serious exacerbations: at least one hospitalization, intensive care unit stay or<br> mechanical ventilation in the previous 12 months.<br><br> 4. Airflow limitation: after appropriate bronchodilator withhold FEV1 <80% predicted<br> (in the face of reduced FEV1/FVC defined as less than the lower limit of normal).<br><br>ii. For the purposes of this study, high-dose ICS will be defined as<br><br> 1. ICS at a cumulative dose of >500 µg fluticasone propionate equivalents daily as<br> defined in Appendix A, or 2. Highest labeled dose of a combination of ICS/LABA. b.<br> Current use of a Food and Drug Administration (FDA)-approved monoclonal antibody<br> agent for treatment of severe asthma (use is not primarily for an alternative<br> condition).<br><br>c. Use of systemic corticosteroids or other systemic immunosuppressants (any dose level)<br>for approximately 50% or more of the prior 12 months for treatment of severe asthma (use<br>is not primarily for an alternative condition).<br><br>Exclusion Criteria<br><br> 1. Not willing and able to sign written informed consent. Consent can be obtained from<br> having a responsible, legally authorized representative acting on patient's behalf.<br><br> 2. Not fluent in English or Spanish.<br><br> 3. Inability to complete study follow-up or web-based PROs. If the patient does not<br> have email or web access, minimal assistance from others to access the web-based PRO<br> is permitted (ie receiving the email and/or assisting patient in navigating to the<br> web page); PROs must be completed by the patient.<br><br> 4. Received an investigational therapy for asthma, allergy, atopic disease, or<br> eosinophilic disease as part of a clinical trial during the 6 months prior to<br> enrollment.<br><br> 1. Once enrolled in the CHRONICLE Study, patients can enroll in trials of<br> investigational therapies (as well as other non-interventional studies) as long<br> as they continue to complete study follow-up. If a patient enrolls in a trial<br> of an investigational therapy, the identity (National Clinical Trial [NCT]<br> number) of the study and dates of the first and last investigational therapy<br> administrations will be collected. If a patient receives blinded therapy in a<br> trial, the Investigator will request the identity of that therapy at trial<br> conclusion so that treatment information collected for the current study may be<br> updated accordingly.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational [Patient Registry]
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthcare utilization- hospitalizations, clinic Visits, and asthma exacerbations;Asthma treatment;Treatment adherence;Asthma control test (ACT);Patient-reported asthma exacerbations;Asthma Impairment and Risk Questionnaire (AIRQ);Work Productivity and Activity Impairment Asthma questionnaire (WPAI-Asthma);St. George's Respiratory Questionnaire (SGRQ);Global evaluation of treatment effectiveness (GETE);Number of Participants With Adverse Events associated with corticosteroid therapy;Relevant respiratory medical events;Respiratory comorbidities;Non-respiratory comorbidities;Events of special interest;Complete blood count with differential including blood eosinophil count.;Total immunoglobulin E (IgE);Radiographic changes in asthma evaluation.;Forced Vital Capacity (FVC);Forced Expiratory Volume in 1 second (FEV1);Fractional exhaled nitric oxide (FENO)