Lung DiseasesNCT00005295
Idiopathic Pulmonary Fibrosis: a Case-control Study
An observational study of Lung Diseases and Pulmonary Fibrosis, run by University of New Mexico.
Trial summary
To determine risk factors for idiopathic pulmonary fibrosis. Read more about this study
- Who is it for?
- Ages 0 to 100 years, men only
- Conditions the study is for
- Lung Diseases, Pulmonary Fibrosis, Lung Diseases, Interstitial
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Jul 1989to Jun 1995
- 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 0 to 100 years
- Men only
- No healthy volunteers
- Child, Adult, Older adult
No eligibility criteria
About this study
To determine risk factors for idiopathic pulmonary fibrosis.
Read the detailed description
BACKGROUND:
Idiopathic pulmonary fibrosis is a progressive and generally fatal disease that causes fibrosis of the pulmonary interstitium. While many environmental agents cause diseases clinically similar, the etiology of idiopathic pulmonary fibrosis suggests that environmental agents could incite the tissue injury that results in the disease; furthermore, host characteristics could have an important role in determining the magnitude of the host response to the agent initiating injury.
DESIGN NARRATIVE:
In this case control study, cases were ascertained at the multiple collaborating centers and controls were identified by telephone screening. A telephone interview was conducted to collect information needed to test hypotheses concerning cigarette smoking, occupational exposure, indoor exposures, other environmental factors, and host factors. To limit disease misclassification, two pathologists experienced with interstitial diseases of the lung reviewed histopathological material from all cases to exclude entities other than interstitial lung fibrosis and to fully characterize the cases clinically. The mortality of this large series of cases was also described.
- Medical subject headings
- Lung Diseases, Pulmonary Fibrosis, Lung Diseases, Interstitial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2000 (estimated)
- Study startJul 1989
- Study completionJun 1995
Why it stopped: Not a clinical Trial \& inadvertently entered in the system.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- 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
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00005295
- Sponsor's protocol ID
- 2018
- Other IDs
- R01HL043153
- Status last verified
- Mar 2024
- First submitted
- 25 May 2000
- Last updated
- 12 Mar 2024
- Results posted
- No
Publications
Baumgartner KB, Samet JM, Stidley CA, Colby TV, Waldron JA. Cigarette smoking: a risk factor for idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1997 Jan;155(1):242-8. doi: 10.1164/ajrccm.155.1.9001319.
PubMed 9001319Coultas DB, Gong H Jr, Grad R, Handler A, McCurdy SA, Player R, Rhoades ER, Samet JM, Thomas A, Westley M. Respiratory diseases in minorities of the United States. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 2):S93-131. doi: 10.1164/ajrccm/149.3_Pt_2.S93. No abstract available.
PubMed 8118656
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pulmonary Fibrosis: a Case-control Study
- ClinicalTrials.gov ID
- NCT00005295
- Acronym / sponsor ID
- 2018
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not a clinical Trial \& inadvertently entered in the system.
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 1989
- Study completion
- Jun 1995
- First posted
- 26 May 2000 (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.
To determine risk factors for idiopathic pulmonary fibrosis.
Detailed description
BACKGROUND:
Idiopathic pulmonary fibrosis is a progressive and generally fatal disease that causes fibrosis of the pulmonary interstitium. While many environmental agents cause diseases clinically similar, the etiology of idiopathic pulmonary fibrosis suggests that environmental agents could incite the tissue injury that results in the disease; furthermore, host characteristics could have an important role in determining the magnitude of the host response to the agent initiating injury.
DESIGN NARRATIVE:
In this case control study, cases were ascertained at the multiple collaborating centers and controls were identified by telephone screening. A telephone interview was conducted to collect information needed to test hypotheses concerning cigarette smoking, occupational exposure, indoor exposures, other environmental factors, and host factors. To limit disease misclassification, two pathologists experienced with interstitial diseases of the lung reviewed histopathological material from all cases to exclude entities other than interstitial lung fibrosis and to fully characterize the cases clinically. The mortality of this large series of cases was also described.
Study design
Who may qualify
- Ages
- 0 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 was stopped early (reason given: Not a clinical Trial \& inadvertently entered in the system.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 9001319Baumgartner KB, Samet JM, Stidley CA, Colby TV, Waldron JA. Cigarette smoking: a risk factor for idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 1997 Jan;155(1):242-8. doi: 10.1164/ajrccm.155.1.9001319.
- Background: PubMed 8118656Coultas DB, Gong H Jr, Grad R, Handler A, McCurdy SA, Player R, Rhoades ER, Samet JM, Thomas A, Westley M. Respiratory diseases in minorities of the United States. Am J Respir Crit Care Med. 1994 Mar;149(3 Pt 2):S93-131. doi: 10.1164/ajrccm/149.3_Pt_2.S93. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Pulmonary Fibrosis, run by University of New Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: Not a clinical Trial \& inadvertently entered in the system.). Results are not available in the source record.
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 NCT00005295, which also lists 2 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 12 Mar 2024.