Chronic Obstructive Pulmonary Disease Clinical Trial
— LASSYCOfficial 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.
NCT number | NCT03381560 |
Other study ID # | D2287R00119 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 7, 2017 |
Est. completion date | June 30, 2018 |
Verified date | June 2019 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 602 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 130 Years |
Eligibility |
INCLUSION CRITERIA Patients will only be included in the study if they meet all of the following criteria: 1. Male or female patients aged 40 years or older. 2. Patient diagnosed with COPD for 1 year or more. 3. Patient presenting at least one spirometry with COPD criteria, FEV1/FVC fixed ratio <0.70 post BD, in the last 12 months. 4. Patient is a current smoker or an ex-smoker with a smoking history of = 10 pack- years. 5. Stable patients, as stated in medical records or patient reports during visit, defined as: without treatment due to exacerbation at study visit or within the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first-time patient from participating in the study). 6. Patients must be able and willing to read and understand written instructions, and understand and complete the questionnaires required by the protocol. 7. After receiving full explanation, patients must have signed an informed consent document indicating that they understand the purpose of and the procedures required for the study and are willing to participate in the study. EXCLUSION CRITERIA Patients who meet any of the following criteria will not be eligible to participate in the study: 1. Patient with a diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases. 2. An acute or chronic condition that, in the investigator's opinion, would limit patient's ability to complete the questionnaires or participate in this study. |
Country | Name | City | State |
---|---|---|---|
Brazil | Research Site | Blumenau | |
Brazil | Research Site | Botucatu | |
Brazil | Research Site | Campinas | |
Brazil | Research Site | Porto Alegre | |
Brazil | Research Site | Rio de Janeiro | |
Brazil | Research Site | Sao Bernardo do Campo | |
Brazil | Research Site | Sao Paulo | |
Brazil | Research Site | São Paulo |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of COPD-related nighttime symptoms | 24 hours | ||
Primary | Mean severity of COPD-related nighttime symptoms | 24 hours | ||
Primary | Frequency of COPD-related daytime symptoms | 24 hours | ||
Primary | Mean severity of COPD-related daytime symptoms | 24 hours | ||
Primary | Frequency of COPD-related early morning symptoms | 24 hours | ||
Primary | Mean severity of COPD-related early morning symptoms | 24 hours | ||
Primary | Interrelationship between early morning, day and nighttime symptoms | 24 hours | ||
Secondary | Relationship between early morning, day and nighttime symptoms and adherence to respiratory medication. | 6 months | ||
Secondary | Relationship between early morning, day and nighttime symptoms and disease classification (GOLD 2013) | 6 months | ||
Secondary | Relationship between early morning, day and nighttime symptoms and disease severity and prognostic assessment (BODEx) | 6 months | ||
Secondary | Relationship between early morning, day and nighttime symptoms and level of dyspnea (mMRC) | 6 months | ||
Secondary | Relationship between early morning, day and nighttime symptoms and HRQoL (CAT) | 6 months | ||
Secondary | Relationship between early morning, day and nighttime symptoms and presence of comorbidities (COTE) | 6 months | ||
Secondary | Relationship between early morning, day and nighttime symptoms and history of exacerbations within the past 12 months | 6 months |
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