Stable COPD PatientsLASSYCNCT02789540
Latin American Study of 24-hs Symptoms in Chronic Obstructive Pulmonary Disease (COPD) Patients; LASSYC Study
An observational study of Stable COPD Patients, run by AstraZeneca at 6 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable COPD Patients
- How many people
- 900 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 10 Jun 2016to 31 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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 Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico
Who may be able to join
- Male or female patients aged 40 years or older.
- Patient has diagnosis of COPD for 1 year or more.
- Patient has at least one spirometry with COPD criteria, fixed ratio <0.70 post bronchodilators (BD), in previous 12 months
- Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack-years.
- Stable patients, as stated in medical records or patient reports during visit, defined as: without exacerbation treatment at study visit neither in the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first consult patient)
- Patients must be able and willing to read and comprehend written instructions, and comprehend and complete the questionnaires required by the protocol
- After 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.
Who cannot join
- Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases.
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
About this study
Official title: An Observational, Multinational, Cross Sectional Primary Data Collection Study to Describe Symptoms Around 24-hs and Their Relationship With Adherence to Respiratory Treatment, Direct Costs and Patient Reported Outcomes (PRO) in Stable COPD Patients in Latin America.
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.
Read the detailed description
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 describe prevalence, severity and interrelationship of early morning, day and night-time symptoms in patients with stable COPD in Latin America (LatAm). Secondary objectives are to evaluate the relationship between early morning, day and night-time symptoms and 2013 GOLD classification, adherence to respiratory treatment (TAI and Morisky Medicaction Adherence Scale - MMAS-8), level of dyspnea (mMRC), disease severity (BODEX), comorbidities (COTE) and physical activity (IPAQ) as well direct costs by assessing health resources utilization (HRU) and exacerbations during last 12 months and respiratory treatment of last 2 months. 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. Data source and study conduct: site staff will retrospectively collect the necessary information from the patient's medical record to determine eligibility. Consecutively, patients with diagnosis and stable COPD will be screened and, if eligible, consented and enrolled. There will be only one study visit. For each patient, the physician will collect the following data at visit (from medical records or interviewing in study visit): social demographics, health insurance system, lifestyle, smoking history, comorbidities, level of dyspnea, disease severity, COPD prescribed treatments including therapeutic class, device, modality (rescue/maintenance) and posology during last past 2 months, exacerbations history and healthcare resources utilisation during last 12 months. In addition, the patient will be asked to provide data on disease-related symptomatology assessed during 24 hs day (early morning, daytime and night time symptoms), adherence to inhalers, health-related quality of life (HRQoL) and physical activity. AstraZeneca will develop Data Management Plan (DMP) and a website database platform for the purpose of this study. Data will be registered by PI directly in a website data platform. The LASSYC study is an observational cross sectional study which does not involve or study a specific medicinal product. Because of the non-interventional nature of this study, a simple monitoring plan is required. 100% of source data verification (SDV) of 10% of total enrolled patients, estimating that one site per country would be enough.The Non-Interventional Study will be performed in accordance with ethical principles that are consistent with the Declaration of Helsinki, International Conference on Harmonization (ICH)and Good Clinical Practice (GCP) and the applicable legislation on Non-Interventional Studies.
- Conditions
- Stable COPD Patients
- Keywords
- COPD symptoms
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and severity of daily COPD symptoms
E-RS Questionnaire
Measured: Day one
Prevalence and severity of early morning COPD symptoms
EMSCI Questionnaire
Measured: Day one
Prevalence and severity of night-time COPD symptoms
NiSCI Questionnaire
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study start10 Jun 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable COPD PatientsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marc Miravitlles, MD, PhD, Study chair, Hospital Universitari Vall d'Hebron. Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789540
- Sponsor's protocol ID
- D2287R00112
- Acronym
- LASSYC
- Status last verified
- Nov 2017
- First submitted
- 30 May 2016
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Miravitlles M, Menezes A, Lopez Varela MV, Casas A, Ugalde L, Ramirez-Venegas A, Mendoza L, Lopez A, Wehrmeister FC, Surmont F, Montes de Oca M. Prevalence and impact of respiratory symptoms in a population of patients with COPD in Latin America: The LASSYC observational study. Respir Med. 2018 Jan;134:62-69. doi: 10.1016/j.rmed.2017.11.018. Epub 2017 Nov 28.
PubMed 29413510Montes de Oca M, Menezes A, Wehrmeister FC, Lopez Varela MV, Casas A, Ugalde L, Ramirez-Venegas A, Mendoza L, Lopez A, Surmont F, Miravitlles M. Adherence to inhaled therapies of COPD patients from seven Latin American countries: The LASSYC study. PLoS One. 2017 Nov 15;12(11):e0186777. doi: 10.1371/journal.pone.0186777. eCollection 2017.
PubMed 29140978
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational, Multinational, Cross Sectional Primary Data Collection Study to Describe Symptoms Around 24-hs and Their Relationship With Adherence to Respiratory Treatment, Direct Costs and Patient Reported Outcomes (PRO) in Stable COPD Patients in Latin America.
- ClinicalTrials.gov ID
- NCT02789540
- Acronym / sponsor ID
- LASSYC / D2287R00112
- Conditions
- Stable COPD Patients
- Keywords
- COPD symptoms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 describe prevalence, severity and interrelationship of early morning, day and night-time symptoms in patients with stable COPD in Latin America (LatAm). Secondary objectives are to evaluate the relationship between early morning, day and night-time symptoms and 2013 GOLD classification, adherence to respiratory treatment (TAI and Morisky Medicaction Adherence Scale - MMAS-8), level of dyspnea (mMRC), disease severity (BODEX), comorbidities (COTE) and physical activity (IPAQ) as well direct costs by assessing health resources utilization (HRU) and exacerbations during last 12 months and respiratory treatment of last 2 months. 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. Data source and study conduct: site staff will retrospectively collect the necessary information from the patient's medical record to determine eligibility. Consecutively, patients with diagnosis and stable COPD will be screened and, if eligible, consented and enrolled. There will be only one study visit. For each patient, the physician will collect the following data at visit (from medical records or interviewing in study visit): social demographics, health insurance system, lifestyle, smoking history, comorbidities, level of dyspnea, disease severity, COPD prescribed treatments including therapeutic class, device, modality (rescue/maintenance) and posology during last past 2 months, exacerbations history and healthcare resources utilisation during last 12 months. In addition, the patient will be asked to provide data on disease-related symptomatology assessed during 24 hs day (early morning, daytime and night time symptoms), adherence to inhalers, health-related quality of life (HRQoL) and physical activity. AstraZeneca will develop Data Management Plan (DMP) and a website database platform for the purpose of this study. Data will be registered by PI directly in a website data platform. The LASSYC study is an observational cross sectional study which does not involve or study a specific medicinal product. Because of the non-interventional nature of this study, a simple monitoring plan is required. 100% of source data verification (SDV) of 10% of total enrolled patients, estimating that one site per country would be enough.The Non-Interventional Study will be performed in accordance with ethical principles that are consistent with the Declaration of Helsinki, International Conference on Harmonization (ICH)and Good Clinical Practice (GCP) and the applicable legislation on Non-Interventional Studies.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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 Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico
Key inclusion criteria (7 listed)
- Male or female patients aged 40 years or older.
- Patient has diagnosis of COPD for 1 year or more.
- Patient has at least one spirometry with COPD criteria, fixed ratio <0.70 post bronchodilators (BD), in previous 12 months
- Patient is a current smoker or an ex-smoker with a smoking history of ≥ 10 pack-years.
- Stable patients, as stated in medical records or patient reports during visit, defined as: without exacerbation treatment at study visit neither in the previous 2 months, and without changes in maintenance COPD treatment regimen over the preceding 2 months (avoid first consult patient)
Key exclusion criteria (2 listed)
- Patient has diagnosis of sleep apnea syndrome or other chronic respiratory disease different from chronic obstructive diseases.
- An acute or chronic condition that, in the investigator's opinion, would limit the patient's ability to complete questionnaires or participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence and severity of daily COPD symptoms
Time frame: Day one
E-RS Questionnaire
Prevalence and severity of early morning COPD symptoms
Time frame: Day one
EMSCI Questionnaire
Prevalence and severity of night-time COPD symptoms
Time frame: Day one
NiSCI Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
- Derived from this study: PubMed 29413510Miravitlles M, Menezes A, Lopez Varela MV, Casas A, Ugalde L, Ramirez-Venegas A, Mendoza L, Lopez A, Wehrmeister FC, Surmont F, Montes de Oca M. Prevalence and impact of respiratory symptoms in a population of patients with COPD in Latin America: The LASSYC observational study. Respir Med. 2018 Jan;134:62-69. doi: 10.1016/j.rmed.2017.11.018. Epub 2017 Nov 28.
- Derived from this study: PubMed 29140978Montes de Oca M, Menezes A, Wehrmeister FC, Lopez Varela MV, Casas A, Ugalde L, Ramirez-Venegas A, Mendoza L, Lopez A, Surmont F, Miravitlles M. Adherence to inhaled therapies of COPD patients from seven Latin American countries: The LASSYC study. PLoS One. 2017 Nov 15;12(11):e0186777. doi: 10.1371/journal.pone.0186777. eCollection 2017.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Miravitlles, MD, PhD study chair
Hospital Universitari Vall d'Hebron. Barcelona
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable COPD Patients, run by AstraZeneca at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Argentina, Chile, Colombia, Costa Rica, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence and severity of daily COPD symptoms (time frame: Day one). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789540, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.