Latin American Study of 24-hs Symptoms in Chronic Obstructive Pulmonary Disease (COPD) Patients; LASSYC Study (LASSYC)

November 6, 2017 updated by: AstraZeneca

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Research Site
  • Chile
      • Santiago, Chile
        • Research Site
  • Colombia
      • Bogota, Colombia
        • Research Site
  • Costa Rica
      • San Jose, Costa Rica
        • Research Site
  • Mexico
      • Mexico City, Mexico
        • Research Site
  • Uruguay
      • Montevideo, Uruguay
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 Argentina, Chile, Colombia, Uruguay, Costa Rica, Guatemala and Mexico

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence and severity of daily COPD symptoms
Time Frame: Day one
E-RS Questionnaire
Day one
Prevalence and severity of early morning COPD symptoms
Time Frame: Day one
EMSCI Questionnaire
Day one
Prevalence and severity of night-time COPD symptoms
Time Frame: Day one
NiSCI Questionnaire
Day one

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Marc Miravitlles, MD, PhD, Hospital Universitari Vall d'Hebron. Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 10, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D2287R00112

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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