Bethesda, Maryland 20892

  • Asthma

Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

130059


NCT ID:

NCT01780142


Secondary ID:

13-H-0059


Study Acronym:


Brief Title:

Longitudinal Observational Study of Severe Asthma


Official Title:

Longitudinal Observational Study of Severe Asthma


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

99 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

2


Total Enrollment:

600


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Amisha V Barochia, M.D.
Principal Investigator
National Heart, Lung, and Blood Institute (NHLBI)
Primary Contact:Joni Y Mills, C.R.N.P.
(301) 402-6623
joni.mills@nih.gov
Backup Contact:Amisha V Barochia, M.D.
(301) 443-7790
barochiaav@mail.nih.gov

Study Dates

Start Date:March 1, 2013
Completion Date:October 1, 2032
Completion Type:Anticipated
Primary Completion Date:October 1, 2032
Primary Completion Type:Anticipated
Verification Date:May 10, 2021
Last Changed Date:May 11, 2021
First Received Date:January 29, 2013

Study Outcomes

Outcome Type: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
Safety Issues:False
Description:we hope to discover novel pathways that can be manipulated to achieve our primary aim of developing new therapies for severe asthmatics.

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:asthmatics
Description:Subjects with confirmed diagnosis of asthma without other lung disease followed forcollection of clinical data & specimens
Study Arm Type:Other
Arm Name:non-asthmatic healthy volunteers
Description:Healthy volunteers in whom asthma has been ruled out and without other lung diseasefollowed for comparison to asthmatics

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Samples and Retentions

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.
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Braman SS. The global burden of asthma. Chest. 2006 Jul;130(1 Suppl):4S-12S. Review.
PMID:16840363
Reference Type:Reference
Citation:Moore WC, Bleecker ER, Curran-Everett D, Erzurum SC, Ameredes BT, Bacharier L, Calhoun WJ, Castro M, Chung KF, Clark MP, Dweik RA, Fitzpatrick AM, Gaston B, Hew M, Hussain I, Jarjour NN, Israel E, Levy BD, Murphy JR, Peters SP, Teague WG, Meyers DA, Busse WW, Wenzel SE; National Heart, Lung, Blood Institute's Severe Asthma Research Program. Characterization of the severe asthma phenotype by the National Heart, Lung, and Blood Institute's Severe Asthma Research Program. J Allergy Clin Immunol. 2007 Feb;119(2):405-13.
PMID:17291857
Reference Type:Reference
Citation:Jarjour NN, Erzurum SC, Bleecker ER, Calhoun WJ, Castro M, Comhair SA, Chung KF, Curran-Everett D, Dweik RA, Fain SB, Fitzpatrick AM, Gaston BM, Israel E, Hastie A, Hoffman EA, Holguin F, Levy BD, Meyers DA, Moore WC, Peters SP, Sorkness RL, Teague WG, Wenzel SE, Busse WW; NHLBI Severe Asthma Research Program (SARP). Severe asthma: lessons learned from the National Heart, Lung, and Blood Institute Severe Asthma Research Program. Am J Respir Crit Care Med. 2012 Feb 15;185(4):356-62. doi: 10.1164/rccm.201107-1317PP. Epub 2011 Nov 17.
PMID:22095547

Data Source: ClinicalTrials.gov

Date Processed: July 28, 2021

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