Longitudinal Observational Study of Severe Asthma

Launched by NATIONAL HEART, LUNG, AND BLOOD INSTITUTE (NHLBI) · Jan 29, 2013

Keywords

ClinConnect Summary

This clinical trial is studying severe asthma, a condition that makes it hard for some people to breathe and can be difficult to treat. Researchers want to learn more about how severe asthma differs from mild or moderate asthma and from people who don’t have asthma at all. By looking at these groups over time, they hope to find new ways to help those with severe asthma who don’t respond well to standard treatments like steroids.

To participate in the study, individuals must be at least 18 years old and have been diagnosed with asthma for at least a year. Healthy volunteers who also meet the age requirement are welcome to join. Participants will start with an initial visit at the NIH Clinical Center, where they will undergo various tests to assess their health and asthma condition. Some may be invited for follow-up visits over several years. Throughout the study, participants will provide valuable information that might lead to better treatments for asthma in the future.

Gender

ALL

Eligibility 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