A Study to Evaluate the Symptoms Over 24 Hours in Patients With Chronic Obstructive Pulmonary Disease - LASSYC Study
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

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.
    

Detailed description: 
      Background

      Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease with some
      significant extrapulmonary effects that may contribute to the severity in individual
      patients. Its pulmonary component is characterized by airflow limitation that is not fully
      reversible. The airflow limitation is usually progressive and associated with an abnormal
      inflammatory response of the lung to noxious particles or gases (i). Although smoking is one
      of the major and most frequent causes of COPD, other factors may be associated with its
      development. The narrowing of the airways, which is one of the main features of COPD, results
      from a combination of small airway disease and parenchymal destruction, as well as structural
      changes from the chronic inflammatory process. For this reason bronchoconstriction is one of
      the key targets of pharmacological interventions in the management of COPD.

      This disease affects globally around 15% of all adults older than 40 years, resulting in
      pulmonary and extrapulmonary comorbidities and significant mortality (1,ii). The worldwide
      prevalence in people aged over 40 years is 10.1% overall, 11.8% for men, and 8.5% for women,
      according to the BOLD Study (iii). It is the fourth leading cause of death in the world and
      its prevalence is projected to increase in the coming years due to continued exposure to COPD
      risk factors (1). Two Latin-American epidemiological studies, the PLATINO Project iv and
      PREPOCOL v, have provided information on the prevalence of COPD in this region. PLATINO is a
      study on prevalence of COPD in individuals ≥40 years, carried out in five Latin American
      cities: Mexico City (Mexico), São Paulo (Brazil), Montevideo (Uruguay), Santiago de Chile
      (Chile), and Caracas (Venezuela). Using as diagnostic criteria post-BD FEV1/FVC ratio
      &lt;0.70, the overall prevalence of COPD in PLATINO is 14.3% (ranging from 7.8% in Mexico
      City to 19.7% in Montevideo) and in the city of São Paulo is 15.8 % (4,vi). Using the lower
      limit of normal criteria (LLN) of the post- BD FEV1/FVC ratio, the global COPD prevalence in
      PLATINO is 11.7%. This is even lower (9.5%) when using the post-BD FEV1/VEF6 &lt; LLN ratio
      (vii). PREPOCOL (5) assessed the prevalence in five cities in Colombia and reported an
      overall prevalence of 8.9% (from 6.2% in Barranquilla to 13,5% in Medellin).

      Symptoms of COPD - including progressive dyspnea, chronic cough, excessive sputum production
      and decreased exercise tolerance - may considerably affect the patients' daily activities and
      quality of life (1,viii,ix). COPD symptoms have been reported to be worse at night and in the
      early morning (x,xi), which may be reflected in disturbed sleep and limitations on morning
      activities.

      Moreover, the health-related quality of life (HRQoL) is being recognized as an important
      outcome when evaluating patients with COPD and several studies have demonstrated that those
      patients in more severe disease stages presented worse HRQoL and it varied greatly within
      each stage of disease severity (xii).

      From the patient´s point of view, dyspnea is one of the major symptoms that affect their
      quality of life (xiii). However, dyspnea varies considerably for the same degree of airflow
      limitation.

      It is reported that poor patient's adherence to inhaled medication is shared by COPD and
      asthma patients (xiv). Non-adherence to inhaled therapy is associated with inadequate symptom
      control, higher healthcare utilization and costs, as well as decreases in health-related
      quality of life (12- 14). In practice guidelines of the Global Initiative for Asthma
      Management [GINA) (xv) and Global Initiative for Chronic Obstructive Lung Disease (GOLD) (1)]
      is now specifically recommended evaluation and follow-up of the patient's adherence to
      inhaler devices.

      Previous studies (xvi, xvii, xviii, xix) have shown that physical activity in COPD is
      associated with a better quality of life and less morbidity and mortality. In addition,
      comorbid conditions such as cardiovascular disease, anxiety and depressive disorders, lung
      cancer and osteoporosis are frequently observed in COPD patients and may affect COPD outcomes
      (xx). Sleep disorder is also common in COPD patients. In epidemiologic studies, more than 50%
      of patients with COPD complained of difficulty to maintain and initiate sleep, and 25%
      complained of excessive daytime sleepiness (xxi). The COTE Index establishes the relationship
      between these main comorbidities and the risk of death over a median of 51 months. This is a
      simple, disease-specific comorbidity index that helps assess the risk of mortality in
      patients with COPD (xxii).

      It has been recently published the ASSESS Study (xxiii) regarding a cohort of 727 European
      patients. This observational study assessed the prevalence, severity and relationship between
      nighttime, early morning and daytime COPD symptoms and explored the relationship between
      24-hour symptoms and other results reported by DPOC patients. It was shown that more than
      half of patients experienced COPD symptoms throughout the whole 24-hour period, and there was
      a significant relationship between them and the worse patient-reported outcome, suggesting
      that improving 24- hour symptoms should be an important consideration in the management of
      COPD.

      COPD is associated with a substantial economic burden due to direct healthcare costs e.g.
      unplanned medical visits and hospitalization due to exacerbations (1,xxiv). More frequent
      exacerbations are associated with: more frequent/longer hospital stays; increased mortality
      risk; reduced quality of life (xxv); as well as indirect/societal costs due to loss of
      productivity and premature death in patients with COPD further increasing the economic burden
      of this disease (1,24-xxvi).

      Rationale

      No previous studies have evaluated the frequency and severity of COPD symptoms over a period
      of 24 hours (nighttime, early morning and daytime symptoms) in stable COPD patients seen in
      clinical practice in Brazil. COPD is a common disorder seen by primary care physicians and
      one of the most common diseases referred and diagnosed by pulmonologists. According to
      studies, COPD symptoms can have a substantial impact on patients' quality of daily life and
      present a considerable degree of variation for the same degree of airflow limitation.

      This study aims to learn more about the burden of symptoms in the real-world population of
      COPD patients in Brazil. With the real life data from this study, it will be possible to
      describe 24-hour COPD symptoms and their impact on patients' quality of life and other PRO,
      the relationship with patients' behaviour regarding adherence to respiratory medication and
      the burden of COPD symptoms in terms of the impact on health economics in Brazil.

      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-time 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 2013 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.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients of 40 years and older, smokers or ex smokers of >= 10 pack/years with previous
        COPD diagnosis, attending outpatient specialists consults in Brazil.
      
Keywords: LASSYC; COPD symptoms.