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Trial record 22 of 158 for:    Diseases | ( Map: Costa Rica )

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

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ClinicalTrials.gov Identifier: NCT02789540
Recruitment Status : Completed
First Posted : June 3, 2016
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief 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 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.

Condition or disease
Stable COPD Patients

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.

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Study Type : Observational
Estimated Enrollment : 900 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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.
Actual Study Start Date : June 10, 2016
Actual Primary Completion Date : October 31, 2016
Actual Study Completion Date : October 31, 2016



Primary Outcome Measures :
  1. Prevalence and severity of daily COPD symptoms [ Time Frame: Day one ]
    E-RS Questionnaire

  2. Prevalence and severity of early morning COPD symptoms [ Time Frame: Day one ]
    EMSCI Questionnaire

  3. Prevalence and severity of night-time COPD symptoms [ Time Frame: Day one ]
    NiSCI Questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02789540


Locations
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Argentina
Research Site
Buenos Aires, Argentina
Chile
Research Site
Santiago, Chile
Colombia
Research Site
Bogota, Colombia
Costa Rica
Research Site
San Jose, Costa Rica
Mexico
Research Site
Mexico City, Mexico
Uruguay
Research Site
Montevideo, Uruguay
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Chair: Marc Miravitlles, MD, PhD Hospital Universitari Vall d'Hebron. Barcelona

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02789540     History of Changes
Other Study ID Numbers: D2287R00112
First Posted: June 3, 2016    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017

Keywords provided by AstraZeneca:
COPD symptoms

Additional relevant MeSH terms:
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Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases