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Latin American Study of 24-hs Symptoms in Chronic Obstructive Pulmonary Disease (COPD) Patients; LASSYC Study

NCT02789540 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 900

Last updated 2017-11-07

No results posted yet for this study

Summary

This is a multi-country, multicentre, observational prospective data collection cross sectional study of patients with stable COPD in Latin America. Primary objective is to assess and characterize COPD symptoms over a period of 24 hours, by collecting information about the respiratory symptoms experienced at different times of the day and night-time in patients with stable COPD under real clinical practice conditions. Correlation between each of these symptoms and the Global Initiative for Chronic Obstructive Lung Disease (GOLD) classification, adherence to respiratory treatment, level of dyspnea, disease severity, comorbidities and physical activity as well direct costs will be done as secondary objectives. Study population are patients of 40 years and older, smokers or ex smokers of \>= 10 pack/years with previous COPD diagnosis, attending outpatient specialists consults in Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico. Sample size is targeted to 900 enroled patients in order to ensure 860 patients to achieve statistical power to primary objective.

Conditions

  • Stable COPD Patients

Sponsors & Collaborators

Principal Investigators

  • Marc Miravitlles, MD, PhD · Hospital Universitari Vall d'Hebron. Barcelona

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-10
Primary Completion
2016-10-31
Completion
2016-10-31

Countries

  • Argentina
  • Chile
  • Colombia
  • Costa Rica
  • Mexico
  • Uruguay

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789540 on ClinicalTrials.gov