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Searching Chronic Obstructive Pulmonary Disease Onset (SOON)

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ClinicalTrials.gov Identifier: NCT03026439
Recruitment Status : Recruiting
First Posted : January 20, 2017
Last Update Posted : January 24, 2017
Sponsor:
Information provided by (Responsible Party):
Pontificia Universidad Catolica de Chile

Brief Summary:
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.

Condition or disease
Copd

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: The Boundaries of Early Chronic Obstructive Pulmonary Disease: Searching COPD Onset
Study Start Date : September 2014
Estimated Primary Completion Date : March 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD

Group/Cohort
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.



Primary Outcome Measures :
  1. Walking distance during the six-minute walking test [ Time Frame: Baseline ]

Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: Baseline ]
    St. George's Respiratory Questionnaire

  2. 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).

  3. 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.

  4. 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.

  5. Lung function [ Time Frame: Baseline ]
    Spirometry, single-breath DLCO, and plethysmographic lung volume assessment will be performed

  6. 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

  7. 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).

  8. 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.



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study subjects will be recruited from the outpatient clinics and the pulmonary function labs at the Pontifical Catholic University of Chile Health Network by means of physician referral, advertisement in clinical areas, or self-referral at the study centre.
Criteria

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

Information from the National Library of Medicine

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


Contacts
Contact: Orlando Diaz, MD 562 ext 226331541 odiaz@med.puc.cl
Contact: Fernando Saldias, MD 562 ext 26331541 fernando.saldias.p@gmail.com

Locations
Chile
Respiratory Department; Hospital Clinico Universidad Catolica Recruiting
Santiago, Region Metropolitana, Chile, 8330033
Contact: Orlando Diaz, MD    562 ext 226331541    odiaz@med.puc.cl   
Contact: Fernando Saldias, MD    562 ext 226331541    fernando.saldias.p@gmail.com   
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Investigators
Principal Investigator: Orlando Diaz, MD Pontificia Universidad Catolica de Chile

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT03026439     History of Changes
Other Study ID Numbers: 13-125b
1141108 ( Other Grant/Funding Number: FONDECYT )
First Posted: January 20, 2017    Key Record Dates
Last Update Posted: January 24, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Pontificia Universidad Catolica de Chile:
mild COPD
early COPD
six-min walk test
computed tomography
emphysema
airway disease
peripheral muscle mass
Saint George's Respiratory Questionnaire

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases