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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Screening Evaluation for Studies of COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00889447
• Other study ID #: NA_00013323
• Secondary ID: 1P50HL084945
• Status: Completed
• Phase: N/A
• First received: April 27, 2009
• Last updated: March 8, 2018
• Start date: January 2008
• Est. completion date: May 2017

Study information

• Verified date: March 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
United States	Johns Hopkins Asthma and Allergy Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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