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

NCT02789540 | Completed

• 1 other identifier: D2287R00112
• Study Type: observational
• Target: 900
• Locations: 5 countries
• Sites: 5

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.

Conditions

Stable COPD Patients

Keywords

COPD symptoms

Outcome Measures

Primary Outcomes (3)

• Prevalence and severity of daily COPD symptoms

  E-RS Questionnaire

  Day one

• Prevalence and severity of early morning COPD symptoms

  EMSCI Questionnaire

  Day one

• Prevalence and severity of night-time COPD symptoms

  NiSCI Questionnaire

  Day one

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Buenos Aires, Argentina

Location

Research Site

Santiago, Chile

Location

Research Site

Bogotá, Colombia

Location

Research Site

San José, Costa Rica

Location

Research Site

Mexico City, Mexico

Location

Research Site

Montevideo, Uruguay

Location

Related Publications (2)

• 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.

  PMID: 29413510 DERIVED

• Montes 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.

  PMID: 29140978 DERIVED

Related Links

• CSR Synopsis

Study Officials

• Marc Miravitlles, MD, PhD

  Hospital Universitari Vall d'Hebron. Barcelona

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2016
• First Posted: June 3, 2016
• Study Start: June 10, 2016
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

CL (1); UR (1); CO (1); ME (1); AR (1)