Screening Evaluation for Studies of Chronic Obstructive Pulmonary Disease (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

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Key information

Conditions

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

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Screening Evaluation for Studies of COPD

Important dates

Study start: 2008
Primary completion: 2017
Study completion: 2017
First posted: Apr 29, 2009
Registry last updated: Mar 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed