Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
An Observational, Cross-sectional Study of Primary Data Collection to Describe Symptoms Over 24 Hours and Their Relationship With Adherence to Respiratory Treatment, Direct Costs and PRO in Stable COPD Patients in Brazil.
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.
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
<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 < 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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|