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Severe asthma under the microscope: new study watches Real-World outcomes

NCT ID NCT03373045

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study followed 18 adults with severe asthma in the United States for at least 3 years. Researchers collected data on treatments, symptoms, hospital visits, and quality of life from medical records and monthly patient surveys. The goal was to understand how severe asthma is managed and how it affects patients over time, without testing any new drug or intervention.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

18 people

The number who actually took part.

Started

Feb 2018

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

It is estimated that 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.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

asthma chronic asthma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Asthma

Contacts and locations

Locations

  • Research Site

    Birmingham, Alabama, 35209, United States

  • Research Site

    Birmingham, Alabama, 35294, United States

  • Research Site

    Hoover, Alabama, 35244, United States

  • Research Site

    Gilbert, Arizona, 85234, United States

  • Research Site

    Peoria, Arizona, 85381, United States

  • Research Site

    Little Rock, Arkansas, 72205, United States

  • Research Site

    Bakersfield, California, 93301, United States

  • Research Site

    Loma Linda, California, 92354, United States

  • Research Site

    Los Angeles, California, 90025, United States

  • Research Site

    Mission Viejo, California, 92691, United States

  • Research Site

    Modesto, California, 95355-4201, United States

  • Research Site

    Redondo Beach, California, 90277, United States

  • Research Site

    Riverside, California, 92506, United States

  • Research Site

    Roseville, California, 95661, United States

  • Research Site

    Sacramento, California, 95819, United States

  • Research Site

    San Diego, California, 92103, United States

  • Research Site

    San Diego, California, 92123, United States

  • Research Site

    San Diego, California, 92130-3318, United States

  • Research Site

    Santa Monica, California, 90404, United States

  • Research Site

    Studio City, California, 91607, United States

  • Research Site

    Ventura, California, 93003, United States

  • Research Site

    Westminster, California, 92683, United States

  • Research Site

    Aurora, Colorado, 80045, United States

  • Research Site

    Danbury, Connecticut, 06810, United States

  • Research Site

    Farmington, Connecticut, 06030, United States

  • Research Site

    New Haven, Connecticut, 06510, United States

  • Research Site

    Waterbury, Connecticut, 06708, United States

  • Research Site

    Newark, Delaware, 19713, United States

  • Research Site

    Brandon, Florida, 33511, United States

  • Research Site

    Clearwater, Florida, 33765, United States

  • Research Site

    Coral Gables, Florida, 33134, United States

  • Research Site

    Gainesville, Florida, 32608, United States

  • Research Site

    Jacksonville, Florida, 32204, United States

  • Research Site

    Kissimmee, Florida, 34759, United States

  • Research Site

    Lake Mary, Florida, 32746, United States

  • Research Site

    Miami, Florida, 33032, United States

  • Research Site

    Miami, Florida, 33175, United States

  • Research Site

    Miami, Florida, 33176, United States

  • Research Site

    Miami Beach, Florida, 33140, United States

  • Research Site

    Pensacola, Florida, 32504, United States

  • Research Site

    Plantation, Florida, 33317, United States

  • Research Site

    St. Petersburg, Florida, 33704, United States

  • Research Site

    Tallahassee, Florida, 32308, United States

  • Research Site

    Tampa, Florida, 32789, United States

  • Research Site

    Tampa, Florida, 33613, United States

  • Research Site

    Albany, Georgia, 31707, United States

  • Research Site

    Decatur, Georgia, 30033, United States

  • Research Site

    Gainesville, Georgia, 30501, United States

  • Research Site

    Villa Rica, Georgia, 30180, United States

  • Research Site

    Boise, Idaho, 83706, United States

  • Research Site

    Chicago, Illinois, 60611, United States

  • Research Site

    Chicago, Illinois, 60612, United States

  • Research Site

    Glen Ellyn, Illinois, 60137, United States

  • Research Site

    Fort Wayne, Indiana, 46804, United States

  • Research Site

    Iowa City, Iowa, 52242, United States

  • Research Site

    West Des Moines, Iowa, 50266, United States

  • Research Site

    Overland Park, Kansas, 66210, United States

  • Research Site

    Georgetown, Kentucky, 40324, United States

  • Research Site

    Lexington, Kentucky, 40503, United States

  • Research Site

    Lexington, Kentucky, 40509, United States

  • Research Site

    Louisville, Kentucky, 40215, United States

  • Research Site

    New Orleans, Louisiana, 70112, United States

  • Research Site

    New Orleans, Louisiana, 70127, United States

  • Research Site

    Shreveport, Louisiana, 71106, United States

  • Research Site

    Bangor, Maine, 04401, United States

  • Research Site

    Rockville, Maryland, 20850, United States

  • Research Site

    Rockville, Maryland, 20852, United States

  • Research Site

    Silver Spring, Maryland, 20902, United States

  • Research Site

    Burlington, Massachusetts, 01805, United States

  • Research Site

    North Dartmouth, Massachusetts, 02747, United States

  • Research Site

    Ann Arbor, Michigan, 48106, United States

  • Research Site

    Ann Arbor, Michigan, 48109, United States

  • Research Site

    Clinton Township, Michigan, 48038, United States

  • Research Site

    Detroit, Michigan, 48202, United States

  • Research Site

    Hamtramck, Michigan, 48211, United States

  • Research Site

    Wyoming, Michigan, 49519, United States

  • Research Site

    Maplewood, Minnesota, 55109, United States

  • Research Site

    Minneapolis, Minnesota, 55455, United States

  • Research Site

    Plymouth, Minnesota, 55402, United States

  • Research Site

    Rochester, Minnesota, 55905, United States

  • Research Site

    St Louis, Missouri, 63110, United States

  • Research Site

    Lincoln, Nebraska, 68505, United States

  • Research Site

    Omaha, Nebraska, 68105, United States

  • Research Site

    Omaha, Nebraska, 68114, United States

  • Research Site

    Omaha, Nebraska, 68124, United States

  • Research Site

    Las Vegas, Nevada, 89106, United States

  • Research Site

    Brick, New Jersey, 08724, United States

  • Research Site

    Marlton, New Jersey, 08053, United States

  • Research Site

    New Brunswick, New Jersey, 08901, United States

  • Research Site

    North Bergen, New Jersey, 07047, United States

  • Research Site

    Northfield, New Jersey, 08225, United States

  • Research Site

    Toms River, New Jersey, 08755, United States

  • Research Site

    Verona, New Jersey, 07044, United States

  • Research Site

    Albuquerque, New Mexico, 87109, United States

  • Research Site

    Bayside, New York, 11361, United States

  • Research Site

    Brooklyn, New York, 11230, United States

  • Research Site

    Brooklyn, New York, 11236, United States

  • Research Site

    Corning, New York, 14830, United States

  • Research Site

    Great Neck, New York, 11023, United States

  • Research Site

    Jamaica, New York, 11418, United States

  • Research Site

    Mineola, New York, 11501, United States

  • Research Site

    New Hyde Park, New York, 11042, United States

  • Research Site

    New Paltz, New York, 12561, United States

  • Research Site

    New York, New York, 10022, United States

  • Research Site

    Rochester, New York, 14621, United States

  • Research Site

    Rochester, New York, 14642, United States

  • Research Site

    Rockville Centre, New York, 11570, United States

  • Research Site

    Staten Island, New York, 10305, United States

  • Research Site

    The Bronx, New York, 10458, United States

  • Research Site

    The Bronx, New York, 10459, United States

  • Research Site

    The Bronx, New York, 10461, United States

  • Research Site

    The Bronx, New York, 10465, United States

  • Research Site

    Valhalla, New York, 10595, United States

  • Research Site

    Asheville, North Carolina, 28801, United States

  • Research Site

    Chapel Hill, North Carolina, 27599, United States

  • Research Site

    Charlotte, North Carolina, 28204, United States

  • Research Site

    Charlotte, North Carolina, 28277, United States

  • Research Site

    Durham, North Carolina, 27701, United States

  • Research Site

    Fayetteville, North Carolina, 28304, United States

  • Research Site

    Greenville, North Carolina, 27834, United States

  • Research Site

    Winston-Salem, North Carolina, 27157, United States

  • Research Site

    Fargo, North Dakota, 58104, United States

  • Research Site

    Toledo, Ohio, 43617, United States

  • Research Site

    Oklahoma City, Oklahoma, 73120, United States

  • Research Site

    Oklahoma City, Oklahoma, 73131, United States

  • Research Site

    Corvallis, Oregon, 97330, United States

  • Research Site

    Portland, Oregon, 97220, United States

  • Research Site

    Portland, Oregon, 97225, United States

  • Research Site

    Altoona, Pennsylvania, 16601, United States

  • Research Site

    Blue Bell, Pennsylvania, 19422, United States

  • Research Site

    DuBois, Pennsylvania, 15801, United States

  • Research Site

    Harrisburg, Pennsylvania, 17109, United States

  • Research Site

    Philadelphia, Pennsylvania, 19107, United States

  • Research Site

    Pittsburgh, Pennsylvania, 15241, United States

  • Research Site

    Sayre, Pennsylvania, 18840, United States

  • Research Site

    Yardley, Pennsylvania, 19067, United States

  • Research Site

    Lincoln, Rhode Island, 02865, United States

  • Research Site

    Clinton, South Carolina, 29325, United States

  • Research Site

    Greenville, South Carolina, 29607, United States

  • Research Site

    Mt. Pleasant, South Carolina, 29464, United States

  • Research Site

    North Charleston, South Carolina, 29420, United States

  • Research Site

    Rock Hill, South Carolina, 29732, United States

  • Research Site

    Franklin, Tennessee, 37064, United States

  • Research Site

    Hendersonville, Tennessee, 37075, United States

  • Research Site

    Aransas Pass, Texas, 78336, United States

  • Research Site

    Beaumont, Texas, 77702, United States

  • Research Site

    Dallas, Texas, 75246, United States

  • Research Site

    Denison, Texas, 75020, United States

  • Research Site

    Duncanville, Texas, 75116, United States

  • Research Site

    Fort Worth, Texas, 76107, United States

  • Research Site

    Houston, Texas, 77030, United States

  • Research Site

    Houston, Texas, 77043, United States

  • Research Site

    Houston, Texas, 77079, United States

  • Research Site

    Katy, Texas, 77450, United States

  • Research Site

    Kingwood, Texas, 77339, United States

  • Research Site

    Live Oak, Texas, 78233, United States

  • Research Site

    McKinney, Texas, 75069, United States

  • Research Site

    San Antonio, Texas, 78251, United States

  • Research Site

    Sugar Land, Texas, 77478, United States

  • Research Site

    Murray, Utah, 84107, United States

  • Research Site

    Salt Lake City, Utah, 84132, United States

  • Research Site

    Lynchburg, Virginia, 24501, United States

  • Research Site

    Newport News, Virginia, 23606, United States

  • Research Site

    Norfolk, Virginia, 23507, United States

  • Research Site

    Richmond, Virginia, 23229, United States

  • Research Site

    Richmond, Virginia, 23235, United States

  • Research Site

    Richmond, Virginia, 23298, United States

  • Research Site

    Tacoma, Washington, 98405, United States

  • Research Site

    Vancouver, Washington, 98664, United States

  • Research Site

    Charleston, West Virginia, 25304, United States

  • Research Site

    Greenfield, Wisconsin, 53228, United States

  • Research Site

    Madison, Wisconsin, 53792-9988, United States

  • Research Site

    Onalaska, Wisconsin, 54650, United States

  • Research Site

    Wausau, Wisconsin, 54401, United States

  • Research Site

    Guaynabo, 00968, Puerto Rico

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