Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier:
NCT02055222
First received: February 4, 2014
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

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- <=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....


Condition
Pulmonary Fibrosis
Lung Disease

Study Type: Observational
Official Title: Clinical Outcomes and Molecular Phenotypes in Smokers With Parenchymal Lung Disease

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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: 4 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Demonstrate divergent regulation of TGF-B1 related molecular pathways in smokers with ILA and IPF patients when compared to patients with COPD. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 223
Study Start Date: January 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
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- <=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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA

For subjects with lung diseases:

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

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, 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

INCLUSION CRITERIA

For Non-Smoking Controls

  • Men and women age 40-80 years
  • No prior history of smoking (this is a non-smoking cohort)

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, 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

INCLUSION CRITERIA

For Smoking Controls

  • Men and women age 40-80 years
  • Subjects who have a prior smoking history

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, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02055222

Contacts
Contact: Mary Haughey, R.N. (301) 496-3632 mhaughey@nhlbi.nih.gov
Contact: Joel Moss, M.D. (301) 496-1597 mossj@nhlbi.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Joel Moss, M.D. National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Heart, Lung, and Blood Institute (NHLBI) )
ClinicalTrials.gov Identifier: NCT02055222     History of Changes
Other Study ID Numbers: 140049, 14-H-0049
Study First Received: February 4, 2014
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
COPD
Smoking
Idiopathic Pulmonary Fibrosis

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Fibrosis
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014