Pulmonary FibrosisNCT02055222
Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
An observational study of Pulmonary Fibrosis and Lung Disease, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
Despite the implementation of modern public health interventions, 1 in 5 adults in the United States are either current or former smokers and remain at risk for the development of chronic lung diseases. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Fibrosis, Lung Disease
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Oct 2014to 23 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: One hundred thirty-eight study subjects with chronic obstructive pulmonary diseases (COPD) and interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF) along with 85 control subjects will be enrolled in this study.
Who may be able to join
- Men and women age 40-80 years
- Smokers with greater than or equal to 10 pack-year history of ever-smoking
- Men and women age 40-80 years
- No prior history of smoking (this is a non-smoking cohort)
- For Smoking Controls
- Men and women age 40-80 years
- Subjects who have a prior smoking history
Who cannot join
- Subjects will be excluded from the study if they meet one or more of the following criteria:
- Subjects who are under the age of 40 or over 80 years old
- Women who are pregnant or lactating
- Have known allergies to lidocaine or medications used for moderate sedation
- Active coronary artery disease
- Cerebral-vascular accident within the past 12 months
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- Active anticoagulation
- Active infections
- Cancer, or a history of cancer within the previous 5 years of screening (other than adequately treated cutaneous basal cell, squamous cell carcinoma, excised melanoma, or carcinoma in situ of the uterine cervix with no evidence of recurrence).
- Poorly controlled chronic diseases
- Unable to provide consent
- Impaired renal function (including dialysis)
- Contraindications to MRI scan including:
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pre-existing medical conditions, including a likelihood of developing seizures or anxiety disorders such as claustrophobia, panic attacks or any psychiatric disorder
- Subjects who are under the age of 40 or over 80 years old
- Women who are pregnant or lactating
- Have known allergies to lidocaine or medications used for moderate sedation
- Active coronary artery disease
- Cerebral-vascular accident within the past 12 months
- Active anticoagulation
- Active infections
- Cancer, or a history of cancer within the previous 5 years of screening (other than adequately treated cutaneous basal cell, squamous cell carcinoma, excised melanoma, or carcinoma in situ of the uterine cervix with no evidence of recurrence).
- Poorly controlled chronic diseases
- Unable to provide consent
- Impaired renal function (including dialysis)
- Contraindications to MRI scan including:
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pre-existing medical conditions, including a likelihood of developing seizures or anxiety disorders such as claustrophobia, panic attacks or any psychiatric disorder
- For Smoking Controls
- Subjects who are under the age of 40 or over 80 years old
- Women who are pregnant or lactating
- Have known allergies to lidocaine or medications used for moderate sedation
- Active coronary artery disease
- Cerebral-vascular accident within the past 12 months
- Active anticoagulation
- Active infections
- Cancer, or a history of cancer within the previous 5 years of screening (other than adequately treated cutaneous basal cell, squamous cell carcinoma, excised melanoma, or carcinoma in situ of the uterine cervix with no evidence of recurrence).
- Poorly controlled chronic diseases
- Unable to provide consent
- Impaired renal function (including dialysis)
- Contraindications to MRI scan including:
- electrical implants such as cardiac pacemakers or perfusion pumps
- ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos near the eye, or steel implants
- ferromagnetic objects such as jewelry or metal clips in clothing
- pre-existing medical conditions, including a likelihood of developing seizures or anxiety disorders such as claustrophobia, panic attacks or any psychiatric disorder
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
Despite the implementation of modern public health interventions, 1 in 5 adults in the United States are either current or former smokers and remain at risk for the development of chronic lung diseases. It is unknown how or why any one individual smoker can develop a wide range of lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles that correspond to divergent pathways in the expression of such proteins as the transforming growth factor-beta1 (TGF-beta <=1). The information generated from this study will provide insight into the pathogenesis of smoking-related lung injury and potentially allow for the development of early therapeutic interventions.
Read the detailed description
Despite the implementation of modern public health interventions, 1 in 5 adults in the United States are either current or former smokers and remain at risk for the development of chronic lung diseases. It is unknown how or why any one individual smoker can develop a wide range of lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles that correspond to divergent pathways in the expression of such proteins as the transforming growth factor-beta1 (TGF-beta1). The information generated from this study will provide insight into the pathogenesis of smoking-related lung injury and potentially allow for the development of early therapeutic interventions.
- Conditions
- Pulmonary Fibrosis, Lung Disease
- Keywords
- COPD, Smoking, Idiopathic Pulmonary Fibrosis, Natural History
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Pulmonary Disease, Chronic Obstructive, Smoking, Idiopathic Pulmonary Fibrosis
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 |
|---|---|---|
| Lung disease (IPF) and smoking history | 50 IPF and 50 COPD patients, and 30 subjects with early interstitial lung abnormalities seen on previous radiographs | |
| Lung disease COPD and smoking history | 50 IPF and 50 COPD patients, and 30 subjects with early interstitial lung abnormalities seen on previous radiographs | |
| Normal Volunteers- Non-smokers, and Smokers | 50 smoking and 30 non-smoking controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine changes in validated clinical parameters of smokers with interstitial lung abnormalities (ILA) as compared to controls and patients with IPF and COPD.
Determine changes in validated clinical parameters of smokers with interstitial lung abnormalities (ILA) as compared to controls and patients with IPF and COPD
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study start14 Oct 2014
- Primary completion1 Jan 2018
- Study completion23 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 7 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
- NCT02055222
- Sponsor's protocol ID
- 140049
- Other IDs
- 14-H-0049
- Status last verified
- May 2022
- First submitted
- 4 Feb 2014
- Last updated
- 1 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
- Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease
- ClinicalTrials.gov ID
- NCT02055222
- Acronym / sponsor ID
- 140049
- Conditions
- Pulmonary Fibrosis, Lung Disease
- Keywords
- COPD, Smoking, Idiopathic Pulmonary Fibrosis, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 14 Oct 2014 (actual)
- Primary completion
- 1 Jan 2018 (actual)
- Study completion
- 23 Aug 2018 (actual)
- First posted
- 5 Feb 2014 (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.
Despite the implementation of modern public health interventions, 1 in 5 adults in the United States are either current or former smokers and remain at risk for the development of chronic lung diseases. It is unknown how or why any one individual smoker can develop a wide range of lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles that correspond to divergent pathways in the expression of such proteins as the transforming growth factor-beta1 (TGF-beta <=1). The information generated from this study will provide insight into the pathogenesis of smoking-related lung injury and potentially allow for the development of early therapeutic interventions.
Detailed description
Despite the implementation of modern public health interventions, 1 in 5 adults in the United States are either current or former smokers and remain at risk for the development of chronic lung diseases. It is unknown how or why any one individual smoker can develop a wide range of lung diseases including chronic obstructive lung disease and/or pulmonary fibrosis. The purpose of this protocol is to collect clinical data, blood, urine, and bronchoalveolar samples from smokers and non-smokers in an attempt to establish phenotypic clinical profiles that correspond to divergent pathways in the expression of such proteins as the transforming growth factor-beta1 (TGF-beta1). The information generated from this study will provide insight into the pathogenesis of smoking-related lung injury and potentially allow for the development of early therapeutic interventions.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lung disease (IPF) and smoking history | – | –50 IPF and 50 COPD patients, and 30 subjects with early interstitial lung abnormalities seen on previous radiographs |
| Lung disease COPD and smoking history | – | –50 IPF and 50 COPD patients, and 30 subjects with early interstitial lung abnormalities seen on previous radiographs |
| Normal Volunteers- Non-smokers, and Smokers | – | –50 smoking and 30 non-smoking controls |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred thirty-eight study subjects with chronic obstructive pulmonary diseases (COPD) and interstitial lung diseases such as idiopathic pulmonary fibrosis (IPF) along with 85 control subjects will be enrolled in this study.
Key inclusion criteria (7 listed)
- Men and women age 40-80 years
- Smokers with greater than or equal to 10 pack-year history of ever-smoking
- Men and women age 40-80 years
- No prior history of smoking (this is a non-smoking cohort)
- For Smoking Controls
Key exclusion criteria (50 listed)
- Subjects will be excluded from the study if they meet one or more of the following criteria:
- Subjects who are under the age of 40 or over 80 years old
- Women who are pregnant or lactating
- Have known allergies to lidocaine or medications used for moderate sedation
- Active coronary artery 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
Determine changes in validated clinical parameters of smokers with interstitial lung abnormalities (ILA) as compared to controls and patients with IPF and COPD.
Time frame: 3 years
Determine changes in validated clinical parameters of smokers with interstitial lung abnormalities (ILA) as compared to controls and patients with IPF and COPD
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.
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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 Fibrosis and Lung 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 7 inclusion and 50 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?
Determine changes in validated clinical parameters of smokers with interstitial lung abnormalities (ILA) as compared to controls and patients with IPF and COPD. (time frame: 3 years). 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.