Chronic Obstructive Pulmonary Disease (COPD) and Domestic Endotoxin (CODE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nadia Hansel, MD MPH, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00890136
First received: April 27, 2009
Last updated: February 27, 2014
Last verified: February 2014
  Purpose

This project aims to characterize the independent effect of domestic endotoxin exposure on health status, as well as pulmonary and systemic inflammation, in former smokers with COPD. Positive findings from this study would be clinically relevant, as they would provide evidence to support aggressive reduction of ongoing endotoxin exposure in patients with COPD. The investigators also hope to make a methodological advance in the field of endotoxin exposure assessment by elucidating whether settled dust and/or airborne endotoxin measurements are the more relevant exposure of interest in epidemiological studies of respiratory disease. To fulfill the specific aims, the investigators will conduct a longitudinal study, including 75 former smokers with COPD. All subjects will have indoor air monitoring, in-home settled dust collections, home inspections as well as assessments of health status, quality of life (QOL), lung function and pulmonary and systemic inflammation.


Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: COpd and Domestic Endotoxin (CODE)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • statistical analysis [ Time Frame: one year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

blood, sputum


Estimated Enrollment: 75
Study Start Date: July 2008
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Both Male and Female 40 years and older

Criteria

Inclusion Criteria:

  • Patient reported physician diagnosis of COPD/Chronic Bronchitis/Emphysema
  • Cigarette Smoking > 10 pack-years
  • Age > 40 years
  • Has not smoked > 1 year
  • Post BD FEV1/FVC ≤ 70%
  • Post BD FEV1 (% predicted) 30-80%
  • Ability and willingness to provide consent

Exclusion Criteria:

  • Non- English speaking
  • Planning to move or live away from the home during the study period
  • Co-morbid illnesses such as:

    • Current physician diagnosis of Asthma
    • Other pulmonary diseases
    • Systemic disease requiring treatment with immunosuppressive agents
    • Known alpha-1 antitrypsin deficiency
    • Occupational exposure with high endotoxin exposure
  • Within the last 6 months Use of oral corticosteroids
  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: NCT00890136

Locations
United States, Maryland
Johns Hopkins Asthma & Allergy Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Nadia Hansel, MD, MPH Johns Hopkins University
  More Information

No publications provided

Responsible Party: Nadia Hansel, MD MPH, Associate Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00890136     History of Changes
Other Study ID Numbers: NA_00017777
Study First Received: April 27, 2009
Last Updated: February 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Chronic Obstructive Pulmonary Disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014