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

Last updated: March 13, 2025
Sponsor: AstraZeneca
Overall Status: Completed

Phase

N/A

Condition

Asthma

Treatment

N/A

Clinical Study ID

NCT03373045
D3250R00023
  • Ages 18-130
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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.

  5. 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.

Study Design

Total Participants: 4519
Study Start date:
February 27, 2018
Estimated Completion Date:
February 14, 2025

Study 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.

Connect with a study center

  • Research Site

    Guaynabo, 00968
    Puerto Rico

    Site Not Available

  • Research Site

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Research Site

    Hoover, Alabama 35244
    United States

    Site Not Available

  • Research Site

    Gilbert, Arizona 85234
    United States

    Site Not Available

  • Research Site

    Peoria, Arizona 85381
    United States

    Site Not Available

  • Research Site

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Research Site

    Bakersfield, California 93301
    United States

    Site Not Available

  • Research Site

    Loma Linda, California 92354
    United States

    Site Not Available

  • Research Site

    Los Angeles, California 90025
    United States

    Site Not Available

  • Research Site

    Mission Viejo, California 92691
    United States

    Site Not Available

  • Research Site

    Modesto, California 95355-4201
    United States

    Site Not Available

  • Research Site

    Redondo Beach, California 90277
    United States

    Site Not Available

  • Research Site

    Riverside, California 92506
    United States

    Site Not Available

  • Research Site

    Roseville, California 95661
    United States

    Site Not Available

  • Research Site

    Sacramento, California 95819
    United States

    Site Not Available

  • Research Site

    San Diego, California 92123
    United States

    Site Not Available

  • Research Site

    Santa Monica, California 90404
    United States

    Site Not Available

  • Research Site

    Studio City, California 91607
    United States

    Site Not Available

  • Research Site

    Ventura, California 93003
    United States

    Site Not Available

  • Research Site

    Westminster, California 92683
    United States

    Site Not Available

  • Research Site

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Research Site

    Danbury, Connecticut 06810
    United States

    Site Not Available

  • Research Site

    Farmington, Connecticut 06030
    United States

    Site Not Available

  • Research Site

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Research Site

    Waterbury, Connecticut 06708
    United States

    Site Not Available

  • Research Site

    Newark, Delaware 19713
    United States

    Site Not Available

  • Research Site

    Brandon, Florida 33511
    United States

    Site Not Available

  • Research Site

    Clearwater, Florida 33765
    United States

    Site Not Available

  • Research Site

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Research Site

    Gainesville, Florida 32608
    United States

    Site Not Available

  • Research Site

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • Research Site

    Kissimmee, Florida 34759
    United States

    Site Not Available

  • Research Site

    Lake Mary, Florida 32746
    United States

    Site Not Available

  • Research Site

    Miami, Florida 33176
    United States

    Site Not Available

  • Research Site

    Miami Beach, Florida 33140
    United States

    Site Not Available

  • Research Site

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Research Site

    Plantation, Florida 33317
    United States

    Site Not Available

  • Research Site

    Saint Petersburg, Florida 33704
    United States

    Site Not Available

  • Research Site

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • Research Site

    Tampa, Florida 32789
    United States

    Site Not Available

  • Research Site

    Albany, Georgia 31707
    United States

    Site Not Available

  • Research Site

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Research Site

    Villa Rica, Georgia 30180
    United States

    Site Not Available

  • Research Site

    Boise, Idaho 83706
    United States

    Site Not Available

  • Research Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Research Site

    Glen Ellyn, Illinois 60137
    United States

    Site Not Available

  • Research Site

    Fort Wayne, Indiana 46804
    United States

    Site Not Available

  • Research Site

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Research Site

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Research Site

    Overland Park, Kansas 66210
    United States

    Site Not Available

  • Research Site

    Georgetown, Kentucky 40324
    United States

    Site Not Available

  • Research Site

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Research Site

    Louisville, Kentucky 40215
    United States

    Site Not Available

  • Research Site

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • Research Site

    Shreveport, Louisiana 71106
    United States

    Site Not Available

  • Research Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • Research Site

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Research Site

    Silver Spring, Maryland 20902
    United States

    Site Not Available

  • Research Site

    Upper Marlboro, Maryland 20772
    United States

    Site Not Available

  • Research Site

    Wheaton, Maryland 20902
    United States

    Site Not Available

  • Research Site

    Burlington, Massachusetts 01805
    United States

    Site Not Available

  • Research Site

    North Dartmouth, Massachusetts 02747
    United States

    Site Not Available

  • Research Site

    Ann Arbor, Michigan 48106
    United States

    Site Not Available

  • Research Site

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Research Site

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Research Site

    Flint, Michigan 48532
    United States

    Site Not Available

  • Research Site

    Hamtramck, Michigan 48211
    United States

    Site Not Available

  • Research Site

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Research Site

    Maplewood, Minnesota 55109
    United States

    Site Not Available

  • Research Site

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Research Site

    Plymouth, Minnesota 55402
    United States

    Site Not Available

  • Research Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Research Site

    Bellevue, Nebraska 68123
    United States

    Site Not Available

  • Research Site

    Lincoln, Nebraska 68505
    United States

    Site Not Available

  • Research Site

    Omaha, Nebraska 68114
    United States

    Site Not Available

  • Research Site

    Las Vegas, Nevada 89106
    United States

    Site Not Available

  • Research Site

    Brick, New Jersey 08724
    United States

    Site Not Available

  • Research Site

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Research Site

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Research Site

    North Bergen, New Jersey 07047
    United States

    Site Not Available

  • Research Site

    Northfield, New Jersey 08225
    United States

    Site Not Available

  • Research Site

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Research Site

    Verona, New Jersey 07044
    United States

    Site Not Available

  • Research Site

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Research Site

    Bayside, New York 11361
    United States

    Site Not Available

  • Research Site

    Bronx, New York 10459
    United States

    Site Not Available

  • Research Site

    Brooklyn, New York 11230
    United States

    Site Not Available

  • Research Site

    Corning, New York 14830
    United States

    Site Not Available

  • Research Site

    Great Neck, New York 11023
    United States

    Site Not Available

  • Research Site

    Jamaica, New York 11418
    United States

    Site Not Available

  • Research Site

    Mineola, New York 11501
    United States

    Site Not Available

  • Research Site

    New Hyde Park, New York 11042
    United States

    Site Not Available

  • Research Site

    New Paltz, New York 12561
    United States

    Site Not Available

  • Research Site

    New York, New York 10022
    United States

    Site Not Available

  • Research Site

    Rochester, New York 14642
    United States

    Site Not Available

  • Research Site

    Rockville Centre, New York 11570
    United States

    Site Not Available

  • Research Site

    Staten Island, New York 10305
    United States

    Site Not Available

  • Research Site

    Valhalla, New York 10595
    United States

    Site Not Available

  • Research Site

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • Research Site

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Research Site

    Charlotte, North Carolina 28204
    United States

    Site Not Available

  • Research Site

    Durham, North Carolina 27701
    United States

    Site Not Available

  • Research Site

    Fayetteville, North Carolina 28304
    United States

    Site Not Available

  • Research Site

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Research Site

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • Research Site

    Toledo, Ohio 43617
    United States

    Site Not Available

  • Research Site

    Oklahoma City, Oklahoma 73131
    United States

    Site Not Available

  • Research Site

    Corvallis, Oregon 97330
    United States

    Site Not Available

  • Research Site

    Portland, Oregon 97225
    United States

    Site Not Available

  • Research Site

    Altoona, Pennsylvania 16601
    United States

    Site Not Available

  • Research Site

    Blue Bell, Pennsylvania 19422
    United States

    Site Not Available

  • Research Site

    DuBois, Pennsylvania 15801
    United States

    Site Not Available

  • Research Site

    Harrisburg, Pennsylvania 17109
    United States

    Site Not Available

  • Research Site

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Research Site

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Research Site

    Sayre, Pennsylvania 18840
    United States

    Site Not Available

  • Research Site

    Yardley, Pennsylvania 19067
    United States

    Site Not Available

  • Research Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • Research Site

    Clinton, South Carolina 29325
    United States

    Site Not Available

  • Research Site

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Research Site

    Mount Pleasant, South Carolina 29464
    United States

    Site Not Available

  • Research Site

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Research Site

    Rock Hill, South Carolina 29732
    United States

    Site Not Available

  • Research Site

    Franklin, Tennessee 37064
    United States

    Site Not Available

  • Research Site

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • Research Site

    Aransas Pass, Texas 78336
    United States

    Site Not Available

  • Research Site

    Beaumont, Texas 77702
    United States

    Site Not Available

  • Research Site

    Dallas, Texas 75246
    United States

    Site Not Available

  • Research Site

    Denison, Texas 75020
    United States

    Site Not Available

  • Research Site

    Duncanville, Texas 75116
    United States

    Site Not Available

  • Research Site

    Fort Worth, Texas 76107
    United States

    Site Not Available

  • Research Site

    Houston, Texas 77030
    United States

    Site Not Available

  • Research Site

    Katy, Texas 77450
    United States

    Site Not Available

  • Research Site

    Kingwood, Texas 77339
    United States

    Site Not Available

  • Research Site

    Live Oak, Texas 78233
    United States

    Site Not Available

  • Research Site

    McKinney, Texas 75069
    United States

    Site Not Available

  • Research Site

    San Antonio, Texas 78251
    United States

    Site Not Available

  • Research Site

    Sugar Land, Texas 77478
    United States

    Site Not Available

  • Research Site

    Murray, Utah 84107
    United States

    Site Not Available

  • Research Site

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Research Site

    Lynchburg, Virginia 24501
    United States

    Site Not Available

  • Research Site

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Research Site

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Research Site

    Richmond, Virginia 23229
    United States

    Site Not Available

  • Research Site

    Williamsburg, Virginia 23188
    United States

    Site Not Available

  • Research Site

    Tacoma, Washington 98405
    United States

    Site Not Available

  • Research Site

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Research Site

    Charleston, West Virginia 25304
    United States

    Site Not Available

  • Research Site

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

  • Research Site

    Madison, Wisconsin 53792-9988
    United States

    Site Not Available

  • Research Site

    Onalaska, Wisconsin 54650
    United States

    Site Not Available

  • Research Site

    Wausau, Wisconsin 54401
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.