Pulmonary DiseaseNCT00001621
Evaluation and Treatment of Patients With Lung Disease Not Participating in Research
An observational study of Pulmonary Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study was developed in order for the professional-staff at the Pulmonary-Critical Care Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their skills and increase their understanding of lung diseases. Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Pulmonary Disease
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 1997to 25 Sep 2020
- 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 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pulmonary disease who do not meet the criteria for existing research protocols.
Who may be able to join
- Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician.
- Consenting to pregnancy testing in minors of childbearing age:
- We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end.
Who cannot join
- Patients without symptoms of pulmonary disease will be excluded from this protocol.
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: Evaluation and Treatment of Pulmonary Patients Not Participating in Research (Training Protocol)
This study was developed in order for the professional-staff at the Pulmonary-Critical Care Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their skills and increase their understanding of lung diseases.
The study will permit PCCMB staff members to evaluate and treat patients with lung disease who do not meet the criteria for other research studies.
Read the detailed description
The professional staff in the Cardiovascular and Pulmonary Branch (CPB) needs to maintain their clinical skills and to enhance their clinical knowledge. The purpose of this protocol is to permit CPB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
- Conditions
- Pulmonary Disease
- Keywords
- Teaching, Pulmonary Disease, Routine Testing, Medically Indicated, Pulmonary Function Test
- 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 |
|---|---|---|
| 1 | Pulmonary Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
The purpose of this protocol is to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
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 start12 Feb 1997
- Primary completion25 Sep 2020
- Study completion25 Sep 2020
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 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
- NCT00001621
- Sponsor's protocol ID
- 970061
- Other IDs
- 97-H-0061
- Status last verified
- Sep 2020
- First submitted
- 3 Nov 1999
- Last updated
- 28 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Pulmonary Patients Not Participating in Research (Training Protocol)
- ClinicalTrials.gov ID
- NCT00001621
- Acronym / sponsor ID
- 970061
- Conditions
- Pulmonary Disease
- Keywords
- Teaching, Pulmonary Disease, Routine Testing, Medically Indicated, Pulmonary Function Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 12 Feb 1997 (actual)
- Primary completion
- 25 Sep 2020 (actual)
- Study completion
- 25 Sep 2020 (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.
This study was developed in order for the professional-staff at the Pulmonary-Critical Care Medical Branch (PCCMB) of the National Heart, Lung, and Blood Institute to maintain their skills and increase their understanding of lung diseases.
The study will permit PCCMB staff members to evaluate and treat patients with lung disease who do not meet the criteria for other research studies.
Detailed description
The professional staff in the Cardiovascular and Pulmonary Branch (CPB) needs to maintain their clinical skills and to enhance their clinical knowledge. The purpose of this protocol is to permit CPB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Pulmonary Patients |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pulmonary disease who do not meet the criteria for existing research protocols.
Key inclusion criteria (3 listed)
- Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician.
- We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end.
Key exclusion criteria (1 listed)
- Patients without symptoms of pulmonary disease will be excluded from this protocol.
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
to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
Time frame: 1 visit
The purpose of this protocol is to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols.
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 28 Sep 2020.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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 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 3 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 28 Sep 2020. 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?
to permit PB staff to evaluate and treat patients with pulmonary disease who do not meet the criteria for existing research protocols. (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 28 Sep 2020; AzTrials last refreshed its copy on 8 Nov 2026.