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

NCT00889447 | Completed DMC

• 2 other identifiers: NA_000133231P50HL084945
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Establish a screening evaluation or characterization

  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

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Both Male and Female 40 years and older

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gregory Diette, MD,MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2009
• First Posted: April 29, 2009
• Study Start: January 1, 2008
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: March 12, 2018

Record last verified: 2018-03

Locations

US (1)