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Clinical Trials/NCT00889447
NCT00889447
Completed
Not Applicable

Screening Evaluation for Studies of COPD

Johns Hopkins University1 site in 1 country670 target enrollmentJanuary 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Johns Hopkins University
Enrollment
670
Locations
1
Primary Endpoint
Establish a screening evaluation or characterization
Status
Completed
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2008
End Date
May 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Establish a screening evaluation or characterization

Time Frame: Determined during screening clinical visit

We 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

Study Sites (1)

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