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

NCT ID: NCT03373045

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 18 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2025-02-14

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.

Detailed Description

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 ICS therapy with additional controllers and/or require systemic corticosteroid or monoclonal antibody therapy. This study will provide a contemporary description of the epidemiology and medical management of United States adults with severe asthma who have not achieved control with high-dose ICS therapy and additional controllers. Additionally, the study will describe the use of and outcomes associated with recently approved monoclonal antibody therapies for severe asthma. Patients will be enrolled from a diverse population of academic and community-based specialist centers across the US. Data will be collected in a naturalistic manner and patient management will not be influenced by the study protocol. At least 1500 patients in the US with a confirmed diagnosis of severe asthma will be enrolled by a diverse set of asthma specialists (eg, allergists and pulmonologists who treat asthma) from academic and community-based centers. Basic de-identified information will be collected for all patients meeting study inclusion criteria, including those not approached for enrollment or who decline enrollment, to enable an assessment of the enrolled and non-enrolled populations. This information will include age, sex, insurance status, age at asthma diagnosis, class of asthma treatment per study inclusion criteria, number of asthma exacerbations in the past 12 months, study eligibility, whether the patient was approached for enrollment, study enrollment status, and reason for not enrolling for those who are approached but do not enroll. Patient-reported asthma control (Asthma Control Test [ACT]), asthma exacerbations, and treatment adherence will be solicited monthly. Patient-reported information on asthma-related healthcare utilization, global evaluation of treatment effectiveness (GETE), and work productivity (Work Productivity and Activity Impairment Asthma questionnaire [WPAI-Asthma]) will be collected at baseline and approximately every 3 months. Detailed information on asthma-related quality of life (Saint George's Respiratory Questionnaire [SGRQ]) as well as presence of an asthma treatment plan will be collected from patients approximately every 6 months. All of the questionnaires will be collected via web-based surveys. Patients will then 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.

Conditions

Asthma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cohort of US adults with severe asthma

To describe patient characteristics, treatment patterns, and health outcomes among a large, geographically diverse cohort of US adults with severe asthma who are not controlled on high-dose ICS with additional controllers and/or require chronic systemic corticosteroid or monoclonal antibody therapy.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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):

a. Uncontrolled asthma while receiving high-dose ICS with additional controllers.

i. Uncontrolled is defined by meeting at least one of the following (as outlined by ATS/ERS [American Thoracic Society/European Respiratory Society] guidelines):

1. 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).

2. Frequent severe exacerbations: two or more bursts of systemic corticosteroids (≥3 days each) in the previous 12 months.

3. Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous 12 months.

4. 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).

ii. 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).

c. 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).

Exclusion Criteria

1. 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.

2. Not fluent in English or Spanish.

3. 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.

4. 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.

1. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parexel

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Birmingham, Alabama, United States

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Birmingham, Alabama, United States

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Hoover, Alabama, United States

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Gilbert, Arizona, United States

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Peoria, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Mission Viejo, California, United States

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Modesto, California, United States

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Redondo Beach, California, United States

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Riverside, California, United States

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Roseville, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Santa Monica, California, United States

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Studio City, California, United States

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Ventura, California, United States

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Westminster, California, United States

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Aurora, Colorado, United States

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Danbury, Connecticut, United States

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Farmington, Connecticut, United States

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New Haven, Connecticut, United States

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Waterbury, Connecticut, United States

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Newark, Delaware, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Coral Gables, Florida, United States

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Gainesville, Florida, United States

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Jacksonville, Florida, United States

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Kissimmee, Florida, United States

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Lake Mary, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Beach, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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St. Petersburg, Florida, United States

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Tallahassee, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Albany, Georgia, United States

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Decatur, Georgia, United States

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Gainesville, Georgia, United States

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Villa Rica, Georgia, United States

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Boise, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Glen Ellyn, Illinois, United States

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Fort Wayne, Indiana, United States

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Iowa City, Iowa, United States

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West Des Moines, Iowa, United States

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Overland Park, Kansas, United States

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Georgetown, Kentucky, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Bangor, Maine, United States

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Rockville, Maryland, United States

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Rockville, Maryland, United States

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Silver Spring, Maryland, United States

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Burlington, Massachusetts, United States

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North Dartmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Ann Arbor, Michigan, United States

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Clinton Township, Michigan, United States

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Detroit, Michigan, United States

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Hamtramck, Michigan, United States

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Wyoming, Michigan, United States

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Maplewood, Minnesota, United States

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Minneapolis, Minnesota, United States

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Plymouth, Minnesota, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Brick, New Jersey, United States

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Marlton, New Jersey, United States

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New Brunswick, New Jersey, United States

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North Bergen, New Jersey, United States

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Northfield, New Jersey, United States

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Toms River, New Jersey, United States

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Verona, New Jersey, United States

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Albuquerque, New Mexico, United States

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Bayside, New York, United States

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Brooklyn, New York, United States

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Brooklyn, New York, United States

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Corning, New York, United States

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Great Neck, New York, United States

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Jamaica, New York, United States

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Mineola, New York, United States

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New Hyde Park, New York, United States

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New Paltz, New York, United States

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New York, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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Rockville Centre, New York, United States

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Staten Island, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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The Bronx, New York, United States

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Valhalla, New York, United States

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Asheville, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Fayetteville, North Carolina, United States

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Greenville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Corvallis, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Altoona, Pennsylvania, United States

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Blue Bell, Pennsylvania, United States

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DuBois, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sayre, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Lincoln, Rhode Island, United States

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Clinton, South Carolina, United States

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Greenville, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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North Charleston, South Carolina, United States

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Rock Hill, South Carolina, United States

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Franklin, Tennessee, United States

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Hendersonville, Tennessee, United States

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Aransas Pass, Texas, United States

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Beaumont, Texas, United States

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Dallas, Texas, United States

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Denison, Texas, United States

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Duncanville, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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Kingwood, Texas, United States

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Live Oak, Texas, United States

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McKinney, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Murray, Utah, United States

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Salt Lake City, Utah, United States

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Lynchburg, Virginia, United States

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Newport News, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Vancouver, Washington, United States

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Charleston, West Virginia, United States

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Greenfield, Wisconsin, United States

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Madison, Wisconsin, United States

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Onalaska, Wisconsin, United States

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Wausau, Wisconsin, United States

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Guaynabo, , Puerto Rico

Countries

United States; Puerto Rico

References

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Trevor J, Lugogo N, Carr W, Moore WC, Soong W, Panettieri RA Jr,, Desai P, Trudo F, Ambrose CS. Severe asthma exacerbations in the United States:: Incidence, characteristics, predictors, and effects of biologic treatments. Ann Allergy Asthma Immunol. 2021 Nov;127(5):579-587.e1. doi: 10.1016/j.anai.2021.07.010. Epub 2021 Jul 15.

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Ambrose CS, Chipps BE, Moore WC, Soong W, Trevor J, Ledford DK, Carr WW, Lugogo N, Trudo F, Tran TN, Panettieri RA Jr. The CHRONICLE Study of US Adults with Subspecialist-Treated Severe Asthma: Objectives, Design, and Initial Results. Pragmat Obs Res. 2020 Jul 16;11:77-90. doi: 10.2147/POR.S251120. eCollection 2020.

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Moore WC, Panettieri RA Jr, Trevor J, Ledford DK, Lugogo N, Soong W, Chipps BE, Carr W, Belton L, Gandhi H, Trudo F, Ambrose CS. Biologic and maintenance systemic corticosteroid therapy among US subspecialist-treated patients with severe asthma. Ann Allergy Asthma Immunol. 2020 Sep;125(3):294-303.e1. doi: 10.1016/j.anai.2020.04.004. Epub 2020 Apr 15.

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Related Links

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CSR Synopsis

Other Identifiers

D3250R00023

Identifier Type: -

Identifier Source: org_study_id