Sample Collections From the Airways of Asthmatic Patients

NCT00001888 | Completed

• 2 other identifiers: 99007699-H-0076
• Study Type: observational
• Target: 574
• Locations: 1 country
• Sites: 1

Brief Summary

Fiberoptic bronchoscopy is a procedure which involves passing a pencil-thin tube into the lung in order to collect fluid and cells from the airways. Fiberoptic bronchoscopy can collect cells from the walls of airways by gently brushing them (bronchial brushing). In addition, squirting small amounts of sterile water in to the airway and gently suctioning it back into the bronchoscope (bronchoalveolar lavage) collects cells. In this study, researchers plan to perform these tests on patients with asthma and normal volunteers. This research may help to improve the understanding of the processes involved in airway inflammation and asthma.

Conditions

Asthma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Assess the role of apolipoprotein and lipid pathways in asthmatic and non-asthmatic subjects.

  These studies will increase the understanding of the pathogenic mechanisms underlying asthmatic airway inflammation and may identify novel therapeutic targets.

  ongoing

Secondary Outcomes (4)

• Assess the role of exosome-associated proteins and receptors in the regulation of airway inflammatory responses

  ongoing

• Assess the expression, regulation, and function of differentially expressed proteins and genes in human airway structural and inflammatory cell populations in asthma

  ongoing

• Assess the relative contribution of specific soluble pro-inflammatory cytokines and receptors in asthmatic bronchoalveolar lavage fluid (BALF) in mediating airway structural and inflammatory cell responses

  ongoing

• Assess the expression, regulation, and function of proteins regulating the release of soluble receptors and mediators from asthmatic inflammatory and structural cell populations

  ongoing

Study Arms (2)

1

Asthmatics

2

Research Volunteers

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any individual between the ages of 18 and 75 with asthma will be accepted into the study. Since asthma has a roughly equivalent prevalence in groups differing in race and gender, recruitment of study participants will be aimed at selecting a study population which reflect this diversity. Asthmatic or research volunteers with HIV infection will be excluded from the study so as not to include patients with HIV-related lymphocytic airway inflammation. Volunteers will be obtained through the NIH Clinical Research Volunteer Program or other standard channels at NIH.

You may qualify if:

• ASTHMATICS:
• 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.
• For women of childbearing potential, negative pregnancy test and willingness to adhere to reliable birth control methods prior to
• bronchoscopy or sputum induction.
• 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.

You may not qualify if:

• 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.
• Research volunteers undergoing a research bronchoscopy will be between 18 and 75 years of age, male or female.
• 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.
• 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.
• 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.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

• Yao X, Kaler M, Qu X, Kalidhindi RSR, Sviridov D, Dasseux A, Barr E, Keeran K, Jeffries KR, Yu ZX, Gao M, Gordon S, Barochia AV, Mills J, Shahid S, Weir NA, Kalchiem-Dekel O, Theard P, Playford MP, Stylianou M, Fitzgerald W, Remaley AT, Levine SJ. Asthmatic patients with high serum amyloid A have proinflammatory HDL: Implications for augmented systemic and airway inflammation. J Allergy Clin Immunol. 2024 Apr;153(4):1010-1024.e14. doi: 10.1016/j.jaci.2023.11.917. Epub 2023 Dec 12.

  PMID: 38092139 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Amisha V Barochia, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 1999
• First Posted: November 4, 1999
• Study Start: June 2, 1999
• Last Updated: May 22, 2026

Record last verified: 2025-08-22

Locations

US (1)