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. 2020 Jul 16;11:77–90. doi: 10.2147/POR.S251120

Table 1.

Patient Inclusion and Exclusion Criteria in the CHRONICLE Study

Inclusion criteria Exclusion criteria

  1. Diagnosis of severe asthma, per ERS/ATS guidelines,2 for ≥12 months prior to enrollment, with investigator confirmation that severe asthma symptoms are not due to an alternative diagnosis

  2. Currently receiving care from specialist physicians (eg, AI) at the investigator’s or sub-investigator’s site

  3. Age ≥18 years

  4. Meeting ≥1 of the following criteria:

    1. Uncontrolled on asthma treatment consistent with GINA Step 4 or 5, receiving high-dosage ICS with additional controllers

      1. Uncontrolled is defined by meeting ≥1 of the following (as outlined by ATS/ERS guidelines):
        1. Poor symptom control: Asthma Control Questionnaire consistently >1.5, ACT <20 (or “not well controlled” by NAEPP/GINA guidelines)
        2. Frequent severe exacerbations: ≥2 bursts of systemic corticosteroids (>3 days each) in the previous 12 months
        3. Serious exacerbations: ≥1 hospitalization, ICU stay, or mechanical ventilation in the last 12 months
        4. Airflow limitation: after appropriate bronchodilator withheld FEV1 <80% predicted (in the face of reduced FEV1/FVC defined as less than the LLN)
      2. For the purposes of this study, high-dosage ICS will be defined as:
        1. ICS at a cumulative dosage of >500 µg fluticasone propionate equivalents daily, or
        2. Highest labeled dosage of a combination of ICS/LABA

    2. Current use of an FDA-approved monoclonal antibody agent for treatment of severe asthma (with use not primarily for an alternative condition)

    3. Use of systemic corticosteroids or other systemic immunosuppressants (any dosage level) for ≥50% of the prior 12 months for treatment of severe asthma (with use not primarily for an alternative condition)

  • Not willing and able to sign written informed consent

  • Not fluent in English or Spanish

  • Unable to complete study follow-up or web-based PROs

  • 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 CHRONICLE, patients can enroll in trials of investigational therapies (as well as other noninterventional studies) as long as they continue to complete study follow-up. If a patient enrolls in a trial of investigational therapy, the identity (NCT number) of the study and dates of the first and last investigational therapy administration will be collected. If the 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

Abbreviations: ACT, Asthma Control Test; AI, allergist/immunologist; ATS, American Thoracic Society; ERS, European Respiratory Society; FDA, US Food and Drug Administration; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; GINA, Global Initiative for Asthma; ICS, inhaled corticosteroids; ICU, intensive care unit; LABA, long-acting beta-agonist; LLN, lower limit of normal; NAEPP, National Asthma Education and Prevention Program; NCT, National Clinical Trial; PRO, patient-reported outcome.