NCT00001618

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 1996

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 1996

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 1999

Completed
18.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2018

Completed
Last Updated

September 5, 2018

Status Verified

August 31, 2018

First QC Date

November 3, 1999

Last Update Submit

September 1, 2018

Conditions

Keywords

Cystic FibrosisHealthy VolunteersAsthmaNormal VolunteerChronic Lung Disease

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 15358694BACKGROUND
  • 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.

    PMID: 12904711BACKGROUND
  • 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.

    PMID: 9517577BACKGROUND

MeSH Terms

Conditions

AsthmaPulmonary FibrosisCystic Fibrosis

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, InterstitialFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsPancreatic DiseasesDigestive System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Joel Moss, M.D.

    National Heart, Lung, and Blood Institute (NHLBI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 1999

First Posted

November 4, 1999

Study Start

November 18, 1996

Study Completion

August 31, 2018

Last Updated

September 5, 2018

Record last verified: 2018-08-31

Locations