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

Completed

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT00890136
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2009-04-27
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Primary Completion: 2014-03
• Study Completion: 2014-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-21
• Last Update Posted: 2019-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
statistical analysis	one year

Trial Locations

Locations (1)

Karina Romero; 🇺🇸 Baltimore, Maryland, United States