Table 3.
Characteristic | TENOR study20 | ISAR15,20 | CHRONICLE study |
Age range, years | ≥6 | ≥18 | ≥18 |
Type of asthma | Severe or difficult-to-treat | Severe | Severe |
Study period | 2001–2004 | Initiated in 2018, no end date | Initiated in 2018, no end date |
Patients, n | 4756 | >10,000 (currently >5000) | 4000 |
Sites, n | 283 | TBD | 102 as of February 2019; targeting 125 |
Country | USA | >14; one site in USA | USA |
Physicians, n | >400 | TBD | 423 (at 102 sites) |
Specialty of physicians at enrolling sites | AIs (54%), pulmonologists (41%) | AIs, pulmonologists | AIs (40%), pulmonologists (42%), both (18%) |
Duration of follow-up, years | 3 | Indefinite | Indefinite; target average of 5 |
Data collected | Natural history of disease, treatments, outcomes, comorbidities, IgE levels | Patient demographics and medical history, outcomes, diagnostic information, clinical characteristics, treatments | Patient demographics and medical history, outcomes, diagnostic information, clinical characteristics, treatments, PROs |
Fixed mandatory study visit(s) | Baseline and every 6 months | Baseline, with no mandatory follow-up visit. Informed consent addressed per local requirements and existing registry structure. Data are collected at subsequent patient visits as they occur | Baseline only; no mandated study visits; however, data are routinely collected from medical records every 6 months |
PROs | Every 6 months: ATAQ Every 12 months: WPAI-Asthma, AQLQ |
None; HCP-reported GINA control questions at every visit | Every month: ACT, treatment adherence, exacerbations Every 3 months: WPAI-Asthma, HCRU; GETE Every 6 months: SGRQ, asthma treatment plan, prescription medication source HCP-reported GINA control questions also collected every 6 months |
Abbreviations: ACT, Asthma Control Test; AI, allergist/immunologist; AQLQ, Asthma Quality of Life Questionnaire; ATAQ, Asthma Therapy Assessment Questionnaire; GETE, Global Evaluation of Treatment Effectiveness; GINA, Global Initiative for Asthma; HCP, health care provider; HCRU, health care resource utilization; IgE, immunoglobulin E; ISAR, International Severe Asthma Registry; PRO, patient-reported outcome; SGRQ, St. George’s Respiratory Questionnaire; TBD, to be determined; TENOR, The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens; WPAI-Asthma, Work Productivity and Activity Impairment Asthma questionnaire.