Status:
COMPLETED
A Study to Evaluate the Symptoms Over 24 Hours in Patients With Chronic Obstructive Pulmonary Disease - LASSYC Study
Lead Sponsor:
AstraZeneca
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-130 years
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 sta...
Detailed Description
Background Chronic Obstructive Pulmonary Disease (COPD) is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients....
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA
- 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.
- EXCLUSION CRITERIA
- 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.
Exclusion
Key Trial Info
Start Date :
November 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
602 Patients enrolled
Trial Details
Trial ID
NCT03381560
Start Date
November 7 2017
End Date
June 30 2018
Last Update
June 28 2019
Active Locations (8)
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1
Research Site
Blumenau, Brazil, 89030-101
2
Research Site
Botucatu, Brazil, 18618970
3
Research Site
Campinas, Brazil, 13083
4
Research Site
Porto Alegre, Brazil, 90035-074