Scientists track severe asthma over years to unlock new treatments
NCT ID NCT01780142
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 8 times
Summary
This study followed 171 adults with severe asthma, milder asthma, or no asthma over several years. Researchers collected health data, lung tests, and samples to understand how severe asthma progresses and differs from other forms. The goal is to find new ways to treat people whose asthma is not controlled by standard medications.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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171 people
The number who actually took part.
- Started
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Mar 2013
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Recruitment of subjects will be aimed at selecting our study population of interest, severe asthmatics of both genders and all races over the age of 18 years. Mild and moderately severe asthmatics, as well as age (+/- 10 years) and gender matched healthy volunteers (non-asthmatics), will be enrolled for comparison to severe asthmatics. Asthmatics with other concomitant conditions, e.g. other lung diseases such as COPD, which may confound the data collected, may be excluded from the study.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* All volunteer subjects must be at least 18 years of age and must be able to provide informed, written consent for participation in this study. Subjects will be recruited irrespective of age, sex, race or ethnicity. Eligibility in the study is determined on the basis of the following inclusion and exclusion criteria. INCLUSION CRITERIA - ASTHMATICS: * Subjects must be over 18 years of age. * Subjects must have had a diagnosis of asthma, as defined by the American Thoracic Society, for at least one year to enter this study. * Subjects must have a history of reversible airflow obstruction, as defined by a positive response to inhaled bronchodilators or a positive methacholine bronchoprovocation challenge by ATS criteria. Severe, refractory asthma will be defined by the 2000 ATS workshop consensus criteria. Refractory asthmatics will meet one or both of the major criteria and at least two minor criteria as outlined in the Protocol. This definition is applicable only to patients in whom (1) other conditions have been excluded, (2) exacerbating factors have been optimally treated, and (3) poor adherence does not appear to be a confounding issue. Compliance or medication adherence will be assessed at the initial and subsequent visits by questioning the subjects about their medication use (self-report). * If asthmatic subjects do not fulfill the criteria for severe asthma, they will be classified as mild to moderate asthmatics. * Subjects must have the ability to provide informed consent. INCLUSION CRITERIA - NON-ASTHMATICS: * Subjects must be at least 18 years of age without a clinical diagnosis of asthma. * Subjects must have no evidence of obstructive airway disease, as defined by ATS criteria on spirometry, and a negative methacholine bronchoprovocation challenge. * Subjects must have the ability to provide informed consent. * Subjects will be matched to asthmatics by gender and age (+/- 10 years). EXCLUSION CRITERIA: * Any concurrent condition (medical, social or behavioral) that, in the opinion of the research team, would preclude or confound acquisition or interpretation of data or delivery of care. * Subjects must not be pregnant
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
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