Chronic bronchitis emphysema
Conditions
Interventions
None listed
Sponsors
Astra Zeneca
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: · Diagnosis, or suspected diagnosis**, of asthma and/or COPD, according to clinician's judgement · Age >=12 years (note: in most countries it will only be feasible to include patients aged >=18 years) · Willing and able to sign written, informed consent (or having a responsible, legally authorised representative acting on patient's behalf) · Enrolment from an active clinical practice
Exclusion criteria
Exclusion criteria: · Patients who participated in any respiratory interventional trial during the 12 months prior to enrolment or at enrolment · Patients who, in the opinion of the physician, are unlikely to complete 3 years of follow-up, e.g. poor literacy, substance abuse, life-threatening co-morbidity · Patients whose primary respiratory diagnosis (i.e. the condition causing most of their respiratory symptoms) is not asthma or COPD (however, a co-diagnosis of another respiratory disease such as bronchiectasis or interstitial lung disease together with asthma or COPD will be accepted) In addition, the following are considered criteria for exclusion from the exploratory genetic research (donation of blood for DNA and RNA analysis) · Previous allogeneic bone marrow transplant · Non-leukocyte depleted whole blood transfusion within 120 days of the date of the genetic sample collection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints are the following, reported for the study population as a whole, by country, by disease (i.e. asthma, COPD and asthma-COPD overlap when considered appropriate) and by specified sub-groups: *Baseline distribution of enrolled patients diagnosed with asthma and/or COPD as per the physician*s clinical judgement, by disease severity and/or control, by site type, by physician characteristics, etc. *Baseline summary statistics (e.g. demographics, physiological, disease information, productivity/HRQoL, treatments, risk factors, healthcare resources use, biomarkers, etc.) of patients by disease severity and/or control, by site type, by physician characteristics, etc. *Longitudinal (at each follow-up assessment) summary statistics, as suggested above, of patients by current disease severity and/or control, by site type, by physician characteristics, etc. *Identification of phenotypic and endotypic groups, based on clinical parameters and biomarkers, that are associated with differential outcomes over time for symptom burden, clinical evolution (including decline in lung function) and healthcare utilisation. The characteristics of these groups at baseline and at each follow-up assessment will be described. *Predictors of phenotypic and endotypic groups, including history of childhood respiratory symptoms, exposure to tobacco smoke, treatment, etc *Correlation between biomarkers and phenotypes and endotypes at baseline and at each follow-up assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary and exploratory endpoints will include the following, reported for the study population as a whole, by country, by disease (i.e. asthma, COPD and asthma-COPD overlap when considered appropriate) and by specified sub-groups: *Concordance by severity and/or control between diagnosis according to guidelines (using the data available at baseline) and according to the initial clinician diagnosis at recruitment *Frequency of treatment modification (dosage change, switch, discontinuation) and reason for modifications between each follow-up assessment Correlation between biomarkers, disease severity and/or control and different measures of response to treatment. *Factors associated with treatment at baseline and patient-reported treatment satisfaction and preference at baseline and at each follow-up assessment *Level of symptom control at baseline and at each follow-up assessment *Frequency of exacerbations according to seasonal variations and conditions, including RTI, in the year prior to enrolment and during the study *Summary scores of PROs overall and by specific subgroups (e.g. treatment patterns, phenotype/endotype, etc.) if considered appropriate, at baseline and at each follow-up assessment *Direct and indirect healthcare resource use by resources categories overall and those related with respiratory disease at baseline and at each follow-up assessment *Presence of known risk factors for development of airways disease *Levels of biomarker parameters, lung function, and risk factors at each follow-up assessment, and variability in these measures. *Relationship between disease control, Health-Related Quality of Life (HRQoL), exacerbations, and healthcare resource use stratified by severity of disease *Reasons for non-adherence to treatment | — |
Countries
Netherlands
Outcome results
None listed