Copd Clinical Trial
— SOONOfficial title:
The Boundaries of Mild Chronic Obstructive Pulmonary Disease: Searching Clinical COPD Onset
Verified date | October 2019 |
Source | Pontificia Universidad Catolica de Chile |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The aim of this study is to determine if presence of dyspnea identifies differences in the 6-min walk test performance among smokers with normal or mild spirometric obstruction, accounting for the confounding effect of heart failure on dyspnea with stress echocardiography.
Status | Completed |
Enrollment | 240 |
Est. completion date | September 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 45 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Age 45 to 80 years - Smoking history >10 pack-year - Mild COPD subjects: Male or female individuals; post-bronchodilator forced expiratory volume in 1 s (FEV1) =80% of predicted normal and post-bronchodilator FEV1/forced vital capacity (FVC) ratio <0.70 - Non-COPD subjects: Male or female individuals; post-bronchodilator FEV1 =80% of predicted normal and post-bronchodilator FEV1/FVC ratio =0.70 Exclusion Criteria: - Unable to tolerate study procedures - Unable to walk or cycle without assistance - Dementia or cognitive disorder, which would prevent the participant from consenting the study or completing study procedures - Major depressive disorder - Locomotor disease that seriously limits exercise tolerance - Untreated symptomatic peripheral artery disease - Body Mass Index >40 kg/m2 - Non-COPD significant pulmonary disease such as asthma; interstitial lung disease; sarcoidosis; tuberculosis; cystic fibrosis; diffuse bronchiectasis; and others - Primary pulmonary hypertension - Current lung cancer - Previous lung resection - Large thoracic metal implants that in opinion of the investigator limit CT scan analyses - Current use of prednisone >5 mg daily - Current use of immunosuppressive agent - Current exposure to chemotherapy or radiation treatments that, in the opinion of the investigator could limit interpretation of pulmonary function, exercise tolerance and CT scan imaging - Current illicit substance abuse, excluding marijuana - Known HIV/AIDS infection - Current extra thoracic cancer, which, in the opinion of their physicians, limits life expectancy to less than 3 years - Recent myocardial infarction (6 months or less) - Chronic congestive heart failure |
Country | Name | City | State |
---|---|---|---|
Chile | Respiratory Department; Hospital Clinico Universidad Catolica | Santiago | Region Metropolitana |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile |
Chile,
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* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Walking distance during the six-minute walking test | Baseline | ||
Secondary | Health related quality of life | St. George's Respiratory Questionnaire | Baseline | |
Secondary | Computed tomography emphysema | Emphysema will be quantitated using the percentage of low-attenuation units less than -950 Hounsfield units (HU) using open source software (www.Slicer.org). | Baseline | |
Secondary | Computed tomography airway thickness | 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. | Baseline | |
Secondary | Computed tomography cross-sectional area of the right thigh muscle | 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. | Baseline | |
Secondary | Lung function | Spirometry, single-breath DLCO, and plethysmographic lung volume assessment will be performed | Baseline | |
Secondary | Stress echocardiography | 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 | Baseline | |
Secondary | Physical activity | 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). | Baseline | |
Secondary | Exercise testing | 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. | Baseline |
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