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

NCT ID: NCT00889447

Last Updated: 2018-03-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 670 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2017-05-31

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Diette, MD,MHS

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

1P50HL084945

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00013323

Identifier Type: -

Identifier Source: org_study_id