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

March 8, 2018 updated by: Johns Hopkins University

Screening Evaluation for Studies of COPD

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

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

670

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21224
        • Johns Hopkins Asthma and Allergy Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Both Male and Female 40 years and older

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Determined during screening clinical visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Gregory Diette, MD,MHS, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2008

Primary Completion (ACTUAL)

May 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

April 27, 2009

First Submitted That Met QC Criteria

April 28, 2009

First Posted (ESTIMATE)

April 29, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 12, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00013323
  • 1P50HL084945 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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