Searching Clinical Chronic Obstructive Pulmonary Disease Onset (SOON)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03026439|
Recruitment Status : Completed
First Posted : January 20, 2017
Last Update Posted : October 11, 2019
|Condition or disease|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||240 participants|
|Official Title:||The Boundaries of Mild Chronic Obstructive Pulmonary Disease: Searching Clinical COPD Onset|
|Actual Study Start Date :||September 2014|
|Actual Primary Completion Date :||June 30, 2018|
|Actual Study Completion Date :||September 30, 2018|
Non-dyspneic smokers/ normal spirometry
Male or female current or former smokers. Forced expiratory volume in 1 s (FEV1)/forced vital capacity (FVC) >0.7. FVC >lower limit of normal (LLN). Modified Medical Research Council (mMRC) dyspnea score = 0.
Dyspneic smokers/ normal spirometry
Male or female current or former smokers. FEV1/FVC >0.7. FVC >LLN. mMRC dyspnea score ≥1.
Non-dyspneic mild COPD patients
Male or female current or former smokers. FEV1/FVC ≤0.7. FEV1 >80% of predicted value. mMRC dyspnea score =0.
Dyspneic mild COPD patients
Male or female current or former smokers. FEV1/FVC ≤0.7. FEV1 >80% of predicted value. mMRC dyspnea score ≥1.
- Walking distance during the six-minute walking test [ Time Frame: Baseline ]
- Health related quality of life [ Time Frame: Baseline ]St. George's Respiratory Questionnaire
- Computed tomography emphysema [ Time Frame: Baseline ]Emphysema will be quantitated using the percentage of low-attenuation units less than −950 Hounsfield units (HU) using open source software (www.Slicer.org).
- Computed tomography airway thickness [ Time Frame: Baseline ]Single-slice airway measurements will be collected in the apical bronchus of the right upper lobe and the right lower lobe posterior basal bronchus. Measurements will be performed in the 3rd, 4th, and 5th airway generation.
- Computed tomography cross-sectional area of the right thigh muscle [ Time Frame: Baseline ]The cross-sectional area of the right thigh muscle will be measured at halfway between the pubic symphysis and the inferior condyle of the femur, in the surface area of the tissue with a density of 40 to 100 HU. This range of density corresponds to the density of muscle tissue.
- Lung function [ Time Frame: Baseline ]Spirometry, single-breath DLCO, and plethysmographic lung volume assessment will be performed
- Stress echocardiography [ Time Frame: Baseline ]Transthoracic stress echocardiography will be performed with a VIVID-7 echocardiography system and echo cardiac stress table, with electrical adjustable slope for an optimal position of the heart. Function in each segment of the left ventricle (LV) will be graded at rest and with stress as normal or hyperdynamic, hypokinetic, akinetic, dyskinetic, or aneurysmal. In addition to the evaluation of segmental function, the global LV response to stress be assessed. Diastolic function will be analysed at rest, and systolic function at rest and end exercise
- Physical activity [ Time Frame: Baseline ]A triaxial accelerometer will be used. This accelerometer measures activity counts and vector magnitude, energy expenditure, steps taken, physical activity intensity, subject position, and ambient light levels. We will retrieve, collect and study three physical activity (PA) outcomes: step count (i.e. movement); spent physical activity time per day (i.e., moderate or vigorous), and PA level (i.e., activity related energy expenditure).
- Exercise testing [ Time Frame: Baseline ]A symptom-limited incremental cycle exercise test will be conducted to measure the maximal workload. A constant work rate cycle endurance test will be performed afterwards.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03026439
|Respiratory Department; Hospital Clinico Universidad Catolica|
|Santiago, Region Metropolitana, Chile, 8330033|
|Principal Investigator:||Orlando Diaz, MD||Pontificia Universidad Catolica de Chile|