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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02789540 |
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Date of registration:
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30/05/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Latin American Study of 24-hs Symptoms in Chronic Obstructive Pulmonary Disease (COPD) Patients; LASSYC Study
LASSYC |
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Scientific title:
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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. |
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Date of first enrolment:
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June 10, 2016 |
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Target sample size:
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900 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02789540 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Argentina
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Chile
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Colombia
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Costa Rica
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Mexico
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Uruguay
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Contacts
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Name:
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Marc Miravitlles, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitari Vall d'Hebron. Barcelona |
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Key inclusion & exclusion criteria
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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
Age minimum:
N/A
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Stable COPD Patients
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Primary Outcome(s)
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Prevalence and severity of early morning COPD symptoms
[Time Frame: Day one]
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Prevalence and severity of night-time COPD symptoms
[Time Frame: Day one]
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Prevalence and severity of daily COPD symptoms
[Time Frame: Day one]
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Secondary ID(s)
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D2287R00112
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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