Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease

NCT02055222 | Completed

• 2 other identifiers: 14004914-H-0049
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Fibrosis; Lung Disease

Keywords

COPD; Smoking; Idiopathic Pulmonary Fibrosis; Natural History

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Men and women age 40-80 years
• Smokers with greater than or equal to 10 pack-year history of ever-smoking

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pulmonary Fibrosis; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Smoking; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Behavior

Study Officials

• Joel Moss, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 5, 2014
• Study Start: October 14, 2014
• Primary Completion: January 1, 2018
• Study Completion: August 23, 2018
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

US (1)