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

NCT ID: NCT00890136

Last Updated: 2019-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-07-31

Study Completion Date

2014-11-30

Brief Summary

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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

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Conditions

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Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nadia Hansel, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Karina Romero

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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NA_00017777

Identifier Type: -

Identifier Source: org_study_id

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