Clinical trial NCT00001618: Segmental Bronchoalveolar Lavage
Official title: Bronchoscopy in Patients With Pulmonary Diseases and Research Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Pulmonary Fibrosis
Keywords: Cystic Fibrosis
Healthy Volunteers
Asthma
Normal Volunteer
Chronic Lung Disease
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Bronchoalveolar lavage (BAL) is a diagnostic and therapeutic procedure conducted by placing a small fiberoptic scope into the lung of a patient, and injecting sterile water (saline) into the lung and removing the fluid. The sterile solution removed contains secretions, cells, and protein from the lower respiratory tract. This sample can be analyzed to provide more information about possible disease processes going on in the lungs.

This protocol will be used to perform BAL, bronchial brushing, and bronchial wall biopsy in normal volunteers and patients with pulmonary disease. The samples collected during the study will be used to examine biochemical processes in the lung that may contribute to lung disease

Detailed description: This protocol proposes to perform bronchoalveolar lavage, bronchial brushing and bronchial wall biopsy in research volunteers and in patients with pulmonary disease to evaluate the cellular components of normal and diseased lungs. This research study will help to improve our understanding of pathogenic mechanisms in the lung during progression of pulmonary disease.

Eligibility criteria: * INCLUSION CRITERIA:

Patients and research volunteers will be accepted for bronchoscopy and bronchoalveolar lavage only if their heath status will not be compromised by the procedure. Examples of disease that may be studied under this protocol include alpha-1 antitrypsin deficiency; lymphangioleiomyomatosis and the cystic lung disease; pulmonary fibrosis; and sarcoidosis.

EXCLUSION CRITERIA:

Patients or research volunteers with abnormalities that contraindicate, or increase the risk of, fiberoptic bronchoscopy and bronchoalveolar lavage, including a history of allergy to atropine, lidocaine, or other topical anesthetics or premedications; FEV(1) less than 0.8 liters; PaO(2), on supplemental 02, of less than 70 mmHg or PaCO(2) greater than 45 mmHg; presence of uncorrected clotting disorder, uncontrolled hypertension, significant cardiac disease, renal or liver failure; metastatic disease; hematologic disorders such as severe anemia (hemoglobin less than or equal to 7 g/ml), granulocytopenia, or platelet disorders.

Patients or research volunteers with a positive serum test for human immunodeficiency virus or hepatitis B or C. The rationale for excluding participation on the basis of HIV seropositivity is because of the known effects of HIV on the lungs.

Patients or research volunteers who are pregnant or lactating.

Patients or research volunteers incapable of giving informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Joel Moss, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elston WJ, Whittaker AJ, Khan LN, Flood-Page P, Ramsay C, Jeffery PK, Barnes NC. Safety of research bronchoscopy, biopsy and bronchoalveolar lavage in asthma. Eur Respir J. 2004 Sep;24(3):375-7. doi: 10.1183/09031936.04.00063003.
citation: Chapman JT, Mehta AC. Bronchoscopy in sarcoidosis: diagnostic and therapeutic interventions. Curr Opin Pulm Med. 2003 Sep;9(5):402-7. doi: 10.1097/00063198-200309000-00011.
citation: Jarjour NN, Peters SP, Djukanovic R, Calhoun WJ. Investigative use of bronchoscopy in asthma. Am J Respir Crit Care Med. 1998 Mar;157(3 Pt 1):692-7. doi: 10.1164/ajrccm.157.3.9705020.