Longitudinal Observational Study of Severe Asthma
| Status: | Recruiting |
|---|---|
| Conditions: | Asthma |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | March 1, 2013 |
| End Date: | October 1, 2032 |
| Contact: | Maryann M Kaler, C.R.N.P. |
| Email: | mk371e@nih.gov |
| Phone: | (301) 451-5916 |
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.
- 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.
Asthma is a common disease and a significant public health problem, affecting one in every 10
individuals, nearly 30 million people in the US alone. About 5-10% of asthmatics have severe
disease that is difficult to control with standard therapies. Severe asthmatics are
considered to be relatively resistant to corticosteroids, a mainstay of therapy in asthma.
Furthermore, chronic corticosteroid therapy often results in side effects that adversely
affect outcomes. Thus, more effective treatment options, which are safe, cost-effective and
easy to administer, are needed for severe asthmatics.
As our understanding of asthma evolves, it is becoming clearer that there are distinct
phenotypes that differ regarding demographic factors such as age, sex and race, but also,
perhaps more importantly, with regards to clinical, physiologic and biologic characteristics.
This heterogeneity may reflect distinct pathogenic mechanisms that result in airflow
obstruction and the clinical presentation of asthma. In turn, a better understanding of the
different factors that contribute to disease severity and pathogenesis will be necessary to
identify new, personalized treatment and management approaches for severe asthmatics. Our
goal is to gain a better understanding of the pathogenic mechanisms that differentiate severe
asthma from mild to moderate asthma, including the role of the above-mentioned factors on
disease control. In so doing, we hope to discover novel pathways that can be manipulated to
achieve our primary aim of developing new therapies for severe asthmatics.
individuals, nearly 30 million people in the US alone. About 5-10% of asthmatics have severe
disease that is difficult to control with standard therapies. Severe asthmatics are
considered to be relatively resistant to corticosteroids, a mainstay of therapy in asthma.
Furthermore, chronic corticosteroid therapy often results in side effects that adversely
affect outcomes. Thus, more effective treatment options, which are safe, cost-effective and
easy to administer, are needed for severe asthmatics.
As our understanding of asthma evolves, it is becoming clearer that there are distinct
phenotypes that differ regarding demographic factors such as age, sex and race, but also,
perhaps more importantly, with regards to clinical, physiologic and biologic characteristics.
This heterogeneity may reflect distinct pathogenic mechanisms that result in airflow
obstruction and the clinical presentation of asthma. In turn, a better understanding of the
different factors that contribute to disease severity and pathogenesis will be necessary to
identify new, personalized treatment and management approaches for severe asthmatics. Our
goal is to gain a better understanding of the pathogenic mechanisms that differentiate severe
asthma from mild to moderate asthma, including the role of the above-mentioned factors on
disease control. In so doing, we hope to discover novel pathways that can be manipulated to
achieve our primary aim of developing new therapies for severe asthmatics.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
Click here to add this to my saved trials
