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Screening Evaluation for Studies of Chronic Obstructive Pulmonary Disease (COPD)

Screening Evaluation for Studies of COPD

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00889447
Enrollment
670
Registered
2009-04-29
Start date
2008-01-31
Completion date
2017-05-31
Last updated
2018-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary disease (COPD)

Brief summary

This research is being done to study mechanisms of progression of COPD and to develop treatments for it. The investigators are doing the present study to identify people age 40 and older with mild to moderate COPD who will qualify for such studies to include in a database. The study will include establishing a screening evaluation or characterization of the following two studies: * Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA\_00009980 * Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA\_00001771

Detailed description

This is a program to recruit and screen participants for clinical trials or more detailed observational studies of COPD. There are no interventions or comparative results to be published from this study.

Interventions

None listed

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Johns Hopkins University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
40 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Age 40 years and older, either sex * Mild to moderate COPD (FEV1/Forced vital capacity (FVC) ratio ≤ 0.70, FEV1 30-70% predicted, Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥35% predicted) * On stable maintenance therapy for 2 months * Current or former smoker (patient report of at least a 10 pack-year history) * Ability to understand and willingness to sign consent documents

Exclusion criteria

* COPD exacerbation requiring treatment within past 6 weeks * Untreated arterial hypertension (systolic blood pressure \> 140 mm Hg, diastolic blood pressure \> 90 mm Hg) * Decompensated heart failure * Myocardial infarction within past 3 months or ever * Evidence of interstitial, occupational or chronic infectious lung disease * Renal dysfunction * Supplemental oxygen \> 2 liters/m at rest * Failure to keep screening appointments

Design outcomes

Primary

MeasureTime frameDescription
Establish a screening evaluation or characterizationDetermined during screening clinical visitWe are doing the present study to identify people to include in a database who are age 40 and older with mild to moderate COPD and who will qualify for studies of COPD. The study will include establishing a screening evaluation or characterization for the following three studies. * Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA\_00009980 * Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease - NA\_00001771 * Genetic Epidemiology of Chronic Obstructive Pulmonary Disease - NA\_00011524

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026