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| ID | Type | Description | Link |
|---|---|---|---|
| 14-H-0049 |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 3 years |
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EXCLUSION CRITERIA: For subjects with lung diseases:
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
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:
INCLUSION CRITERIA: For Non-Smoking Controls
EXCLUSION CRITERIA: For Non-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:
INCLUSION CRITERIA
For Smoking Controls
EXCLUSION CRITERIA
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:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Joel Moss, M.D. | National Heart, Lung, and Blood Institute (NHLBI) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | United States |
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| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D008171 | Lung Diseases |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012907 | Smoking |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D008173 | Lung Diseases, Obstructive |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D001519 | Behavior |