Longitudinal Observational Study of Severe Asthma (NCT01780142) | Clinical Trial Compass
CompletedNot Applicable
Longitudinal Observational Study of Severe Asthma
United States171 participantsStarted 2013-03-01
Plain-language summary
Background:
\- Asthma is a lung condition that causes difficulty breathing and decreased lung function. Some people with asthma have more severe disease symptoms. They may be less responsive to standard treatments such as steroids. Researchers want to compare severe asthmatics with mild or moderate asthmatics or people without asthma over a long period. This information may help identify new treatments for people whose asthma is not well controlled by standard medications.
Objectives:
\- To compare severe asthmatics with mild or moderate asthmatics, and healthy volunteers, to study the progression and outcomes of the disease.
Eligibility:
* Individuals at least 18 years of age who have been diagnosed with asthma for at least 1 year.
* Healthy volunteers at least 18 years of age.
Design:
* This study will involve an initial visit to the NIH Clinical Center for all participants. Selected participants may be asked to return for repeat visits over a number of years. The test results from participants with asthma will be compared with those from the healthy volunteers.
* All participants will be screened with a physical exam and medical history.
* Participants may (but will not necessarily) have the following tests at each visit:
* Complete medical history and physical exam
* Blood, urine, sputum, and nasal cell samples
* Breath tests and heart and lung function tests
* Six-minute walk test to measure ability to exercise
* Imaging studies such as chest x-rays, bone density scans, and sinus scans
* Allergy skin testing
* Vocal cord exam
* Overnight sleep study
* Participants may remain on the study for as long as they are willing to participate and do not develop health problems that will interfere with the study.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is already completed — is the data it collected about severe versus mild or moderate asthma relevant to understanding my specific situation, and can you walk me through what that research found?
2Since this was an observational study just tracking people over time rather than testing a treatment, does it give us any useful information about the natural course of severe asthma that could help guide decisions about my care?
3The study compared people with severe asthma to those with mild or moderate asthma — based on where my asthma falls on that spectrum, what does the longitudinal data suggest about the complications or outcomes I might be at risk for?
4The trial tracked co-morbid conditions alongside asthma — are there specific conditions that commonly showed up alongside severe asthma in this kind of research that you think I should be monitored for?
5Rather than joining a study like this, would it make more sense for me right now to focus on standard treatment options for my asthma severity, and are there any active trials you'd recommend looking into instead?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To collect longitudinal data regarding the natural history, co-morbid conditions, complications and outcomes of severe asthmatics as compared to mild or moderate asthmatics and non-asthmatics
Timeframe: all
Trial details
NCT IDNCT01780142
SponsorNational Heart, Lung, and Blood Institute (NHLBI)