AsthmaNCT01780142
Longitudinal Observational Study of Severe Asthma
An observational study of Asthma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Asthma
- How many people
- 171 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2013to 12 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
- Subjects must be at least 18 years of age without a clinical diagnosis of asthma.
Show all 9Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Asthma
- Keywords
- Airflow Obstruction, Corticosteroid Resistance, Exacerbations, Quality of Life, Airway Inflammation, Natural History
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| asthmatics | Subjects with confirmed diagnosis of asthma without other lung disease followed for collection of clinical data \& specimens | |
| non-asthmatic healthy volunteers | Healthy volunteers in whom asthma has been ruled out and without other lung disease followed for comparison to asthmatics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
we hope to discover novel pathways that can be manipulated to achieve our primary aim of developing new therapies for severe asthmatics.
Measured: all
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study start1 Mar 2013
- Primary completion12 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Amisha V Barochia, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780142
- Sponsor's protocol ID
- 130059
- Other IDs
- 13-H-0059
- Status last verified
- 26 Feb 2026
- First submitted
- 29 Jan 2013
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Publications
Barochia AV, Gordon EM, Kaler M, Cuento RA, Theard P, Figueroa DM, Yao X, Weir NA, Sampson ML, Stylianou M, Choy DF, Holweg CTJ, Remaley AT, Levine SJ. High density lipoproteins and type 2 inflammatory biomarkers are negatively correlated in atopic asthmatics. J Lipid Res. 2017 Aug;58(8):1713-1721. doi: 10.1194/jlr.P077776. Epub 2017 Jun 27.
PubMed 28655726Barochia AV, Kaler M, Cuento RA, Gordon EM, Weir NA, Sampson M, Fontana JR, MacDonald S, Moss J, Manganiello V, Remaley AT, Levine SJ. Serum apolipoprotein A-I and large high-density lipoprotein particles are positively correlated with FEV1 in atopic asthma. Am J Respir Crit Care Med. 2015 May 1;191(9):990-1000. doi: 10.1164/rccm.201411-1990OC.
PubMed 25692941
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Observational Study of Severe Asthma
- ClinicalTrials.gov ID
- NCT01780142
- Acronym / sponsor ID
- 130059
- Conditions
- Asthma
- Keywords
- Airflow Obstruction, Corticosteroid Resistance, Exacerbations, Quality of Life, Airway Inflammation, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 12 Sep 2024 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthmatics | – | –Subjects with confirmed diagnosis of asthma without other lung disease followed for collection of clinical data \& specimens |
| non-asthmatic healthy volunteers | – | –Healthy volunteers in whom asthma has been ruled out and without other lung disease followed for comparison to asthmatics |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: all
we hope to discover novel pathways that can be manipulated to achieve our primary aim of developing new therapies for severe asthmatics.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Background: PubMed 28655726Barochia AV, Gordon EM, Kaler M, Cuento RA, Theard P, Figueroa DM, Yao X, Weir NA, Sampson ML, Stylianou M, Choy DF, Holweg CTJ, Remaley AT, Levine SJ. High density lipoproteins and type 2 inflammatory biomarkers are negatively correlated in atopic asthmatics. J Lipid Res. 2017 Aug;58(8):1713-1721. doi: 10.1194/jlr.P077776. Epub 2017 Jun 27.
- Background: PubMed 25692941Barochia AV, Kaler M, Cuento RA, Gordon EM, Weir NA, Sampson M, Fontana JR, MacDonald S, Moss J, Manganiello V, Remaley AT, Levine SJ. Serum apolipoprotein A-I and large high-density lipoprotein particles are positively correlated with FEV1 in atopic asthma. Am J Respir Crit Care Med. 2015 May 1;191(9):990-1000. doi: 10.1164/rccm.201411-1990OC.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
Construction and Validation of an Impulse Oscillometry (IOS)-Based Platform for Screening, Diagnosis, and Management of Chronic Airway Diseases
Chronic Obstructive Pulmonary Disease (COPD), Asthma (Diagnosis)
RecruitingObservational study
Swiss Severe Asthma Register
Severe Asthma
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amisha V Barochia, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: all). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01780142, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.