AsthmaNCT00001618
Segmental Bronchoalveolar Lavage
An observational study of Asthma and Pulmonary Fibrosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Pulmonary Fibrosis
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 1996to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Bronchoscopy in Patients With Pulmonary Diseases and Research Volunteers
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
Read the 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.
- Conditions
- Asthma, Pulmonary Fibrosis
- Keywords
- Cystic Fibrosis, Healthy Volunteers, Asthma, Normal Volunteer, Chronic Lung Disease
- Medical subject headings
- Asthma, Pulmonary Fibrosis, Cystic Fibrosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start18 Nov 1996
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joel Moss, M.D., Principal investigator, National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001618
- Sponsor's protocol ID
- 970022
- Other IDs
- 97-H-0022
- Status last verified
- 31 Aug 2018
- First submitted
- 3 Nov 1999
- Last updated
- 5 Sep 2018
- Results posted
- No
Publications
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.
PubMed 15358694Chapman 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.
PubMed 12904711Jarjour 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.
PubMed 9517577
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopy in Patients With Pulmonary Diseases and Research Volunteers
- ClinicalTrials.gov ID
- NCT00001618
- Acronym / sponsor ID
- 970022
- Conditions
- Asthma, Pulmonary Fibrosis
- Keywords
- Cystic Fibrosis, Healthy Volunteers, Asthma, Normal Volunteer, Chronic Lung Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 18 Nov 1996
- Study completion
- 31 Aug 2018
- First posted
- 4 Nov 1999 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2018.
- Background: PubMed 15358694Elston 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.
- Background: PubMed 12904711Chapman 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.
- Background: PubMed 9517577Jarjour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joel Moss, M.D. principal investigator
National Heart, Lung, and Blood Institute (NHLBI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma and Pulmonary Fibrosis, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001618, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2018.