Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease

Completed

• Conditions: Lung Disease; Pulmonary Fibrosis

• Registration Number: NCT02055222
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

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.

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 Timeline

• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Study Start: 2014-10-14
• Primary Completion: 2018-01-01
• Study Completion: 2018-08-23
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-27
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	Determine changes in validated clinical parameters of smokers with interstitial lung abnormalities (ILA) as compared to controls and patients with IPF and COPD

Trial Locations

Locations (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States