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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert A. Wise, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00889447
First received: April 27, 2009
Last updated: April 1, 2013
Last verified: April 2013
History of Changes
  Purpose

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

Condition
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Screening Evaluation for Studies of COPD

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Biospecimen Retention:   Samples Without DNA

blood


Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Both Male and Female 40 years and older

Criteria

Inclusion Criteria:

  • Age 40 years and older, either sex
  • Mild to moderate COPD (FEV1/FVC ratio ≤ 0.70, FEV1 30-70% predicted, 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 > 2L/m at rest
  • Failure to keep screening appointments
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00889447

Locations
United States, Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Gregory Diette, MD,MHS Johns Hopkins University
  More Information

No publications provided

Responsible Party: Robert A. Wise, Professor of Medicine, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00889447     History of Changes
Other Study ID Numbers: NA_00013323
Study First Received: April 27, 2009
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Chronic Obstructive Pulmonary disease (COPD)

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013