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Protocol Details

Longitudinal Observational Study of Severe Asthma

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

13-H-0059

Sponsoring Institute

National Heart, Lung and Blood Institute (NHLBI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Airflow Obstruction;
Corticosteroid Resistance;
Exacerbations;
Quality of Life;
Airway Inflammation

Recruitment Keyword(s)

None

Condition(s)

Asthma

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Heart, Lung, and Blood Institute

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.

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Eligibility

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


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Amisha V. Barochia, M.D.
National Heart, Lung and Blood Institute (NHLBI)
BG 10-CRC RM 6-3130
10 CENTER DR
BETHESDA MD 20814
(301) 443-7790
barochiaav@mail.nih.gov

Joni Y. Mills, C.R.N.P.
National Heart, Lung and Blood Institute (NHLBI)
BG 10 RM 6D03
10 CENTER DR
BETHESDA MD 20814
(301) 402-6623
joni.mills@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01780142

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