Observational study of severe asthma
Longitudinal Observational Study of Severe Asthma
This study looks at people with severe asthma compared to those with milder forms and healthy individuals to see how their condition changes over time and find better treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT01780142 on ClinicalTrials.gov |
What this trial studies
This study aims to compare individuals with severe asthma to those with mild or moderate asthma and healthy volunteers over an extended period. Researchers will analyze the progression and outcomes of asthma, focusing on the differences in disease severity and treatment responses. Participants will undergo an initial visit at the NIH Clinical Center, with potential follow-up visits to gather long-term data on their condition. The goal is to identify new treatment pathways for severe asthma that are more effective and personalized.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with asthma for at least one year, particularly those with severe or refractory asthma.
Not a fit: Patients with mild asthma or those who do not have asthma may not receive any benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to the development of new, more effective treatments for patients with severe asthma.
How similar studies have performed: Other studies have shown success in understanding asthma phenotypes and treatment responses, making this approach promising but still requiring further exploration.
Eligibility criteria
Show full inclusion / exclusion criteria
* 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Amisha V Barochia, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
- Study coordinator: Joni Y Mills, C.R.N.P.
- Email: joni.mills@nih.gov
- Phone: (301) 402-6623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.