A Study to Evaluate the Symptoms Over 24 Hours in Patients With Chronic Obstructive Pulmonary Disease - LASSYC Study

NCT03381560 | Completed

• 1 other identifier: D2287R00119
• Study Type: observational
• Target: 602
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

LASSYC; COPD symptoms.

Outcome Measures

Primary Outcomes (7)

• Frequency of COPD-related nighttime symptoms

  24 hours

• Mean severity of COPD-related nighttime symptoms

  24 hours

• Frequency of COPD-related daytime symptoms

  24 hours

• Mean severity of COPD-related daytime symptoms

  24 hours

• Frequency of COPD-related early morning symptoms

  24 hours

• Mean severity of COPD-related early morning symptoms

  24 hours

• Interrelationship between early morning, day and nighttime symptoms

  24 hours

Secondary Outcomes (7)

• Relationship between early morning, day and nighttime symptoms and adherence to respiratory medication.

  6 months

• Relationship between early morning, day and nighttime symptoms and disease classification (GOLD 2013)

  6 months

• Relationship between early morning, day and nighttime symptoms and disease severity and prognostic assessment (BODEx)

  6 months

• Relationship between early morning, day and nighttime symptoms and level of dyspnea (mMRC)

  6 months

• Relationship between early morning, day and nighttime symptoms and HRQoL (CAT)

  6 months

Eligibility Criteria

• Age: 40 Years - 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: 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 Brazil.

You may qualify if:

• Patients will only be included in the study if they meet all of the following criteria:
• Male or female patients aged 40 years or older.
• Patient diagnosed with COPD for 1 year or more.
• Patient presenting at least one spirometry with COPD criteria, FEV1/FVC fixed ratio \<0.70 post BD, in the last 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 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).
• Patients must be able and willing to read and understand written instructions, and understand and complete the questionnaires required by the protocol.
• 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.

You may not qualify if:

• Patients who meet any of the following criteria will not be eligible to participate in the study:
• Patient with a 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 patient's ability to complete the questionnaires or participate in this study.

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (8)

Research Site

Blumenau, 89030-101, Brazil

Location

Research Site

Botucatu, 18618970, Brazil

Location

Research Site

Campinas, 13083, Brazil

Location

Research Site

Porto Alegre, 90035-074, Brazil

Location

Research Site

Rio de Janeiro, 20551-030, Brazil

Location

Research Site

São Bernardo do Campo, 09750-420, Brazil

Location

Research Site

São Paulo, 04023-062, Brazil

Location

Research Site

São Paulo, 5403000, Brazil

Location

Related Publications (1)

• Cukier A, Godoy I, Costa CHD, Rubin AS, Gregorio MG, Albuquerque Neto AA, Lima MA, Pereira MC, Tanni SE, Athanazio RA, Bessa EJC, Wehrmeister FC, Lourenco CB, Menezes AMB. Symptom variability over the course of the day in patients with stable COPD in Brazil: a real-world observational study. J Bras Pneumol. 2019 Dec 20;46(3):e20190223. doi: 10.36416/1806-3756/e20190223. eCollection 2020.

  PMID: 31859705 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alberto Cukier

  Instituto do Coração do Hospital das Clínicas da FMUSP

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 18, 2017
• First Posted: December 22, 2017
• Study Start: November 7, 2017
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: June 28, 2019

Record last verified: 2019-06

Locations

BR (8)