Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic obstructive pulmonary disease, COPD
Brief summary
Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit. For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries
Detailed description
Observational, cross-sectional study with retrospective data collection from medical records. During the cross-sectional study visit, data will be captured through the use of electronic Case Report Forms (eCRFs). As there will be only one study visit, no prospective data collection will take place, nor collection of data that are not part of the routine clinic visit. For understanding the burden of severe exacerbations of COPD and the association between frequency of severe exacerbations and clinical and health-care utilization outcomes in less well-resourced countries Patients, treated by pulmonologists, with an investigator-confirmed diagnosis of COPD for at least 5 years from the index date (the date that signed Informed Consent was obtained) and who meet all of the inclusion and none of the exclusion criteria
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients will be included if they meet the following inclusion criteria: 1. have an investigator-confirmed diagnosis of COPD of at least 5 years and are over the age of 40 years old; 2. are smokers or ex-smokers (quit smoking no longer than 15 years before the study visit); 3. have COPD-related data recorded in (electronic) medical records for at least 5 years, including spirometry and medication data; 4. have signed a written Informed Consent Form
Exclusion criteria
* Patients will be excluded from participation if they meet any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimate the frequency of severe Acute exacerbation of COPD, in a COPD population | 5 YEAR | Number of severe Acute exacerbation of COPD events and interval between severe AECOPDs over the past 5 years |
| c) To describe lung function decline over time (FEV1) | 5 YEAR | At least 2 (Forced expiratory volume in 1 second)FEV1 measurements at least 6 months apart |
| Health care resource utilization in AECOPD | 5 YEARS | Number of hospitalizations due to AECOPD in 60 months prior to study visit and time between hospitalizations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Modified Medical Research Council (mMRC) dyspnea scale measured at time of the visit | 1 YEAR | Modified Medical Research Council (mMRC) dyspnea questionnaire to asses the grade as follow: * Grade 0: I only get breathless with strenuous exercise * Grade 1: I get short of breath when hurrying on the level or walking up a slight hill * Grade 2: I walk slower than people of the same age on the level because of breathlessness, or I have to stop for breath when walking on my own pace on the level * Grade 3: I stop for breath after walking about 100 meters or after a few minutes on the level * Grade 4: I am too breathless to leave the house or I am breathless when dressing or undressing |
Countries
Chile, Mexico, Russia, Taiwan
Outcome results
None listed