Collecting airway samples from asthmatic patients

Asthma Sample Collection Protocol

This study is trying to collect samples from the airways of people with asthma to learn more about what causes their symptoms and how asthma affects their lungs.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT00001888 on ClinicalTrials.gov

What this trial studies

This observational study involves performing fiberoptic bronchoscopy on patients with asthma and normal volunteers to collect fluid and cells from the airways. The procedures include bronchial brushings, bronchoalveolar lavage, and the collection of sputum and exhaled breath condensates. The goal is to evaluate the molecular mechanisms underlying airway inflammation, hyperresponsiveness, and remodeling in asthmatic subjects. By understanding these processes, researchers aim to enhance the knowledge of asthma pathogenesis.

Who should consider this trial

Good fit: Ideal candidates are asthmatic patients aged 18 to 75 with a documented history of reversible airway obstruction.

Not a fit: Patients with a history of allergy to methacholine or those who do not meet the asthma diagnostic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this research could lead to improved understanding and management of asthma.

How similar studies have performed: Other studies utilizing similar bronchoscopy techniques have shown promise in understanding asthma and related conditions.

Eligibility criteria

* INCLUSION CRITERIA:

ASTHMATICS:

1. Patients undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female. The diagnosis of asthma requires a history of intermittent, reversible expiratory flow limitation. In addition, patients will have demonstrated evidence of either an abnormal methacholine challenge or reversible airway obstruction. An abnormal methacholine challenge will be defined as a decrease in FEV1 of at least 20% at a PD20 dose \< 200 microgram. Reversible airway obstruction will be defined as an improvement of at least 10% in either the FEV1 or FVC following bronchodilator treatment. Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of reversible airflow obstruction.
2. For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to

   bronchoscopy or sputum induction.
3. Asthmatic research subjects who will only be providing research blood specimens, nasal epithelial lining fluid, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may participate in the protocol by providing a clinical history that they have asthma and are not pregnant. Documentation of an abnormal methacholine challenge or reversible airflow obstruction or a negative pregnancy test, for women of childbearing age, will not be required for donation of research blood specimens, or other non-invasive samples, such as nasal epithelial lining fluid, sputum, or exhaled breath condensate.

EXCLUSION CRITERIA:

ASTHMATICS:

Diagnosis of a pulmonary disorder other than asthma (e.g., chronic bronchitis, cystic fibrosis, HIV-related lymphocytic airway inflammation).

History of drug or alcohol abuse within the past year.

Positive test for human immunodeficiency virus (to exclude patients with HIV-related lymphocytic airway inflammation) or hepatitis virus.

INCLUSION CRITERIA - RESEARCH VOLUNTEERS:

1. Research volunteers undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female.
2. A negative inhalational methacholine challenge as defined by the absence of a 20% decrease in FEV1 at a PD20 dose of \> 400 microgram (normal bronchial hyperresponsiveness). Methacholine challenge testing will not be performed if the subject has a history of allergy to methacholine. Results of testing performed by the subject s primary care provider may be accepted as evidence of a negative methacholine challenge.
3. For women of childbearing potential, negative pregnancy test within 2 weeks prior to bronchoscopy and willingness to adhere to reliable birth control methods prior to bronchoscopy or sputum induction.
4. Research volunteers who will only be providing research blood specimens, nasal epithelial lining fluid, sputum, spontaneously expectorated sputum, or exhaled breath condensate, and will not be undergoing a research bronchoscopy or sputum induction, may be included in the protocol without documentation of a negative inhalational methacholine challenge or a negative pregnancy test if they provide a history that they do not have asthma and that they are not currently pregnant, for women of childbearing age.

EXCLUSION CRITERIA - RESEARCH VOLUNTEERS:

Same as the asthmatic exclusion criteria plus a history of asthma.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Amisha V Barochia, M.D. — National Heart, Lung, and Blood Institute (NHLBI)
• Study coordinator: Joni Y Mills, C.R.N.P.

Conditions Asthma; Induced Sputum; Exhaled Breath Condensate; Fiberoptic Bronchoscopy; Bronchoscopy; mRNA; Natural History