Phase
Condition
Asthma
Treatment
N/AClinical Study ID
Ages 18-130 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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.
Currently receiving care from specialist physicians (eg, pulmonologists and or allergists) at the Investigator's or sub-investigator's site.
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):
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).
Frequent severe exacerbations: two or more bursts of systemic corticosteroids (≥3 days each) in the previous 12 months.
Serious exacerbations: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous 12 months.
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
- 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
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.
Not fluent in English or Spanish.
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.
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 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
Study Description
Connect with a study center
Research Site
Guaynabo, 00968
Puerto RicoSite Not Available
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Birmingham, Alabama 35209
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Hoover, Alabama 35244
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Gilbert, Arizona 85234
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Peoria, Arizona 85381
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Little Rock, Arkansas 72205
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Bakersfield, California 93301
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Loma Linda, California 92354
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Los Angeles, California 90025
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Mission Viejo, California 92691
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Modesto, California 95355-4201
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Redondo Beach, California 90277
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Riverside, California 92506
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Roseville, California 95661
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Sacramento, California 95819
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San Diego, California 92123
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Santa Monica, California 90404
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Studio City, California 91607
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Ventura, California 93003
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Westminster, California 92683
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Aurora, Colorado 80045
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Danbury, Connecticut 06810
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Farmington, Connecticut 06030
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New Haven, Connecticut 06510
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Waterbury, Connecticut 06708
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Newark, Delaware 19713
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Brandon, Florida 33511
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Clearwater, Florida 33765
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Coral Gables, Florida 33134
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Gainesville, Florida 32608
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Jacksonville, Florida 32204
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Kissimmee, Florida 34759
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Lake Mary, Florida 32746
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Miami, Florida 33176
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Miami Beach, Florida 33140
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Pensacola, Florida 32504
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Plantation, Florida 33317
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Saint Petersburg, Florida 33704
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Tallahassee, Florida 32308
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Tampa, Florida 32789
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Albany, Georgia 31707
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Decatur, Georgia 30033
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Villa Rica, Georgia 30180
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Boise, Idaho 83706
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Chicago, Illinois 60611
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Glen Ellyn, Illinois 60137
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Fort Wayne, Indiana 46804
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Iowa City, Iowa 52242
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West Des Moines, Iowa 50266
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Overland Park, Kansas 66210
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Georgetown, Kentucky 40324
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Lexington, Kentucky 40509
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Louisville, Kentucky 40215
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New Orleans, Louisiana 70112
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Shreveport, Louisiana 71106
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Bangor, Maine 04401
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Rockville, Maryland 20850
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Silver Spring, Maryland 20902
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Upper Marlboro, Maryland 20772
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Wheaton, Maryland 20902
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Burlington, Massachusetts 01805
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North Dartmouth, Massachusetts 02747
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Ann Arbor, Michigan 48106
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Clinton Township, Michigan 48038
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Detroit, Michigan 48202
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Flint, Michigan 48532
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Hamtramck, Michigan 48211
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Wyoming, Michigan 49519
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Maplewood, Minnesota 55109
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Minneapolis, Minnesota 55455
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Plymouth, Minnesota 55402
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Saint Louis, Missouri 63110
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Bellevue, Nebraska 68123
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Lincoln, Nebraska 68505
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Omaha, Nebraska 68114
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Las Vegas, Nevada 89106
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Brick, New Jersey 08724
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Marlton, New Jersey 08053
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New Brunswick, New Jersey 08901
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North Bergen, New Jersey 07047
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Northfield, New Jersey 08225
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Toms River, New Jersey 08755
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Verona, New Jersey 07044
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Albuquerque, New Mexico 87109
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Bayside, New York 11361
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Bronx, New York 10459
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Brooklyn, New York 11230
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Corning, New York 14830
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Great Neck, New York 11023
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Jamaica, New York 11418
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Mineola, New York 11501
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New Hyde Park, New York 11042
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New Paltz, New York 12561
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New York, New York 10022
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Rochester, New York 14642
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Rockville Centre, New York 11570
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Staten Island, New York 10305
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Valhalla, New York 10595
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Asheville, North Carolina 28801
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Chapel Hill, North Carolina 27599
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Charlotte, North Carolina 28204
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Durham, North Carolina 27701
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Fayetteville, North Carolina 28304
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Winston-Salem, North Carolina 27157
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Fargo, North Dakota 58104
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Toledo, Ohio 43617
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Oklahoma City, Oklahoma 73131
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Corvallis, Oregon 97330
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Portland, Oregon 97225
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Altoona, Pennsylvania 16601
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Blue Bell, Pennsylvania 19422
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DuBois, Pennsylvania 15801
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Harrisburg, Pennsylvania 17109
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Philadelphia, Pennsylvania 19107
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Pittsburgh, Pennsylvania 15241
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Sayre, Pennsylvania 18840
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Yardley, Pennsylvania 19067
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Warwick, Rhode Island 02886
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Clinton, South Carolina 29325
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Greenville, South Carolina 29607
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Mount Pleasant, South Carolina 29464
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North Charleston, South Carolina 29420
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Rock Hill, South Carolina 29732
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Franklin, Tennessee 37064
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Hendersonville, Tennessee 37075
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Aransas Pass, Texas 78336
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Beaumont, Texas 77702
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Dallas, Texas 75246
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Denison, Texas 75020
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Duncanville, Texas 75116
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Fort Worth, Texas 76107
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Houston, Texas 77030
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Katy, Texas 77450
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Kingwood, Texas 77339
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Live Oak, Texas 78233
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McKinney, Texas 75069
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San Antonio, Texas 78251
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Sugar Land, Texas 77478
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Murray, Utah 84107
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Salt Lake City, Utah 84132
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Lynchburg, Virginia 24501
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Newport News, Virginia 23606
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Norfolk, Virginia 23507
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Richmond, Virginia 23229
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Williamsburg, Virginia 23188
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Tacoma, Washington 98405
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Vancouver, Washington 98664
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Charleston, West Virginia 25304
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Greenfield, Wisconsin 53228
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Madison, Wisconsin 53792-9988
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Onalaska, Wisconsin 54650
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Wausau, Wisconsin 54401
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