MedTrace Logo

A Study to Evaluate the Symptoms Over 24 Hours in Patients With Chronic Obstructive Pulmonary Disease - LASSYC Study

NCT03381560 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 602

Last updated 2019-06-28

No results posted yet for this study

Summary

No previous studies have evaluated the frequency and severity of Chronic Obstructive Pulmonary Disease (COPD) symptoms over a period of 24 hours (early morning, daytime and nigth-time symptoms) in stable COPD patients seen in clinical practice in Brazil. COPD is a common disease seen by primary care physicians and one of the most common diseases referred and diagnosed by pulmonologists. According to previous studies, symptoms of COPD can have a substantial impact on patients' quality of life and present a considerable degree of variation for the same degree of airflow limitation.

The objective of this study is to learn more about the burden of symptoms in the real-world population of COPD patients in Brazil. With the real life data coming from this study, it will be possible to describe 24-hour COPD symptoms in Brazil and their impact on patients' quality of life and other PROs, the relationship with patients´ behaviour regarding adherence to respiratory medication and burden of COPD symptoms in terms of the impact on health economics.

In the present study, the investigators will 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 in patients with stable COPD under real clinical practice conditions. In addition, the investigators will evaluate the correlation between each of these symptoms and the GOLD classification, adherence to respiratory treatment, level of dyspnea, disease severity, comorbidities and physical activity. Finally, the investigators will assess the relationship between 24h symptoms and direct cost related to treatment and HRU in the previous year to assess the burden of COPD symptoms.

The present study is based on a similar protocol applied in Latin-American patients, the LASSYC Study. Extracted data will be used for a Brazilian analysis of these outcomes and may be used in future analyses combined with the results of LASSYC Study for a global view of Latin America.

Conditions

Sponsors & Collaborators

Principal Investigators

  • Alberto Cukier · Instituto do Coração do Hospital das Clínicas da FMUSP

Eligibility

Min Age
40 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-07
Primary Completion
2018-06-30
Completion
2018-06-30

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases
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 NCT03381560 on ClinicalTrials.gov