Pulmonary DiseaseNCT00001183
Evaluation of the Causes and Disease Processes of Chronic Lung Disease
An observational study of Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Chronic lung diseases are disorders associated with abnormalities in any of the structures involved in the process of breathing and bringing oxygen into the lungs and blood. This includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the tissue covering the lungs (pleura). Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Pulmonary Disease
- How many people
- 6,564 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 1984to 16 Dec 2019
- 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 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients being screened for lung disease
Who may be able to join
- Symptoms consistent with pulmonary disease.
- May have family history of lung disease.
- Patients with diseases of organs with known association with lung disease.
- Ranging in age from 7 to 90 years old.
- Pregnant and nursing women may participate in minimal risk procedures
Who cannot join
- Persons with no clinical evidence of lung disease.
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: Comprehensive Evaluation of the Etiology and Pathogenesis of Chronic Lung Disease (Screening Protocol)
Chronic lung diseases are disorders associated with abnormalities in any of the structures involved in the process of breathing and bringing oxygen into the lungs and blood. This includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the tissue covering the lungs (pleura).
The purpose of this research study is to evaluate patients referred to the Cardiovascular and Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to;
- Develop a better understanding of the causes and disease processes involved in disorders of the lungs
- Identify patients eligible to participate in other P-CCMB research studies
Read the detailed description
The chronic lung diseases are those disorders associated with functional and/or structural derangement to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. The purpose of this project is to permit the comprehensive evaluation of patients referred to the Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other NHLBI protocols. Testing and procedures will only be performed when medically indicated for the purposes of making a diagnosis or obtaining information likely to be useful in the management of the subjects' disease or condition.
- Conditions
- Pulmonary Disease
- Keywords
- Computed Tomography, Fiberoptic Bronchoscopy, Pulmonary Function Testing, Cardiopulmonary Exercise Testing, Allergen Skin Testing
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Pulmonary Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
N/A-screening protocol
Evaluate
Measured: 1 Visit
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 1984
- Primary completion16 Dec 2019
- Study completion16 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 6,564 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
- NCT00001183
- Sponsor's protocol ID
- 820032
- Other IDs
- 82-H-0032
- Status last verified
- May 2022
- First submitted
- 3 Nov 1999
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Evaluation of the Etiology and Pathogenesis of Chronic Lung Disease (Screening Protocol)
- ClinicalTrials.gov ID
- NCT00001183
- Acronym / sponsor ID
- 820032
- Conditions
- Pulmonary Disease
- Keywords
- Computed Tomography, Fiberoptic Bronchoscopy, Pulmonary Function Testing, Cardiopulmonary Exercise Testing, Allergen Skin Testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,564 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 18 Nov 1984 (actual)
- Primary completion
- 16 Dec 2019 (actual)
- Study completion
- 16 Dec 2019 (actual)
- 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.
Chronic lung diseases are disorders associated with abnormalities in any of the structures involved in the process of breathing and bringing oxygen into the lungs and blood. This includes abnormalities in the airways, lungs, blood vessels in and around the lungs, and the tissue covering the lungs (pleura).
The purpose of this research study is to evaluate patients referred to the Cardiovascular and Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to;
- Develop a better understanding of the causes and disease processes involved in disorders of the lungs
- Identify patients eligible to participate in other P-CCMB research studies
Detailed description
The chronic lung diseases are those disorders associated with functional and/or structural derangement to the alveolar structures, airways, pulmonary blood vessels, pleura and/or mediastinum. The purpose of this project is to permit the comprehensive evaluation of patients referred to the Pulmonary Branch of the National Heart, Lung, and Blood Institute (NHLBI) in order to: (1) develop an understanding of the etiology and pathogenesis of these disorders; and (2) identify individuals who will be suitable candidates for other NHLBI protocols. Testing and procedures will only be performed when medically indicated for the purposes of making a diagnosis or obtaining information likely to be useful in the management of the subjects' disease or condition.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Pulmonary Patients |
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients being screened for lung disease
Key inclusion criteria (5 listed)
- Symptoms consistent with pulmonary disease.
- May have family history of lung disease.
- Patients with diseases of organs with known association with lung disease.
- Ranging in age from 7 to 90 years old.
- Pregnant and nursing women may participate in minimal risk procedures
Key exclusion criteria (1 listed)
- Persons with no clinical evidence of lung disease.
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
N/A-screening protocol
Time frame: 1 Visit
Evaluate
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 1 Jun 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Disease
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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 Pulmonary Disease, 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 5 inclusion and 1 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 1 Jun 2022. 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.
What does the primary outcome measure?
N/A-screening protocol (time frame: 1 Visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2022; AzTrials last refreshed its copy on 7 Nov 2026.