Please select the outcome measures that correspond to the clinical trial below.
Title: The CHRONICLE Study: A Longitudinal Prospective Observational Study of the Characteristics, Treatment Patterns and Health Outcomes of Individuals With Severe Asthma in the United States
Brief Summary: The CHRONICLE Study is a multi-center, non-interventional, prospective cohort study of adults 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. Data will be collected from the healthcare provider in a uniform manner for every patient enrolled using an electronic case report form (eCRF). Data will be collected monthly from patients via web-based surveys. Patients will be followed until study discontinuation or the patient withdraws from the study or death, whichever occurs first. The expectation is that patients will be followed for a period of at least 3 years.


Options:
A: Persistency of Response and Non-response as Based on Investigator's Global Evaluation of Treatment Effectiveness (GETE) (Weeks 16 and 32)
B: Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (Throughout the study); Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis. (Throughout the study)
C: Healthcare utilization- hospitalizations, clinic Visits, and asthma exacerbations (At baseline, every 6 months, through study completion, assessed up to 7 years.); Asthma treatment (At baseline, every 6 months, through study completion, assessed up to 7 years.); Treatment adherence (At baseline, every 1 month, through study completion, assessed up to 7 years.); Asthma control test (ACT) (Change from baseline, every 1 month, through study completion, assessed up to 4 years.); Patient-reported asthma exacerbations (Change from baseline, every 1 month, through study completion, assessed up to 4 years.); Asthma Impairment and Risk Questionnaire (AIRQ) (At baseline, every 1 month, through study completion, assessed up to 4 years); Work Productivity and Activity Impairment Asthma questionnaire (WPAI-Asthma) (At baseline, every 3 months, through study completion, assessed up to 7 years.); St. George's Respiratory Questionnaire (SGRQ) (At baseline, every 6 months, through study completion, assessed up to 7 years.); Global evaluation of treatment effectiveness (GETE) (At baseline, every 6 months, through study completion, assessed maximum up to 7 years.); Number of Participants With Adverse Events associated with corticosteroid therapy (At baseline, every 6 months, through study completion, assessed up to 7 years.); Relevant respiratory medical events (At baseline, every 6 months, through study completion,assessed up to 7 years.); Respiratory comorbidities (At baseline, every 6 months, through study completion, assessed up to 7 years.); Non-respiratory comorbidities (At baseline, every 6 months, through study completion, assessed up to 7 years.); Events of special interest (At baseline, every 6 months, through study completion, assessed up to 7 years.); Complete blood count with differential including blood eosinophil count. (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Total immunoglobulin E (IgE) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Radiographic changes in asthma evaluation. (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Forced Vital Capacity (FVC) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Forced Expiratory Volume in 1 second (FEV1) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.); Fractional exhaled nitric oxide (FENO) (Change from baseline, every 6 months, through study completion, assessed up to 7 years.)
D: Annual Asthma Exacerbation Rate in Adult and Adolescent Patients With Uncontrolled Asthma for Eosinophils >=300/uL (Immediately following the first administration of study drug through Study Week 48.)

Answer: C