Real-world, 52-week Prospective Study to Capture the Reasons for Switch to Triple Combination Therapy, Assess the Clinical and Patient Reported Outcomes in Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Trixeo Aerosphere™ in Routine Care Settings in Greece
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female outpatients aged 40 to 80 years (inclusive) at the time of BGF MDI initiation.
COPD diagnosis for at least 12 months before BGF MDI initiation in accordance with the definition by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2022 Report, as assessed per physician's routine practice or as documented in the patient's chart.
Patients who have been prescribed but not yet initiated treatment with Budesonide Glycopyrronium bromide Formoterol fumarate pressurized Metered Dose Inhaler (BGF MDI) according to the Summary of Product Characteristics (SmPC) and local market reimbursement criteria. Prescription of BGF MDI must have occurred prior to signed Informed Consent (IC) and the decision to prescribe this therapy must by clearly separated from the physician's decision to include the patient in the current study.
Spirometry-determined moderate to severe disease defined as post-bronchodilator (post-BD) Forced Expiratory Volume in 1 Second (FEV1)/Forced vital capacity (FVC) ratio \<0.70 and FEV1 \<80% predicted normal value based on most recent spirometry performed within the 3-month period prior to BGF MDI initiation.
Current or former conventional cigarette smokers with a history of at least 10 pack-years of smoking.
Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol.
Patients must provide a written IC prior to inclusion to the study.
You may not be if
COPD due to documented α-1 antitrypsin deficiency.
Subjects with current diagnosis of active tuberculosis, lung cancer or lung metastasis, significant bronchiectasis, sarcoidosis, pulmonary fibrosis, pulmonary hypertension, interstitial lung diseases or other active clinically significant pulmonary diseases.
Subjects with other uncontrolled disease.
Recent (≤3 months) major cardiac or pulmonary event (for example myocardial infarction, pulmonary embolism).
Respiratory tract infection \[including, among others, Coronavirus Disease 2019 (COVID-19)\] that has not resolved ≤30 days prior to BGF MDI initiation.
Requirement of long term (at least 15 hours daily) oxygen therapy.
Current or recent (≤4 weeks prior to BGF MDI initiation) long-term chronic maintenance use of systemic corticosteroids or antibiotic treatment for any reason other than COPD.
Current or recent (≤4 weeks prior to BGF MDI initiation) participation in the acute phase of a Pulmonary Rehabilitation Program.
Currently pregnant (or intention to become pregnant), breastfeeding or lactating women.
Participation in a non-interventional observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in any interventional observational or clinical trial in the last 30 days prior to enrollment
Clareo Health | Real-world, 52-week Prospective Study to Capture the Reasons for Switch to Triple Combination Therapy, Assess the Clinical and Patient Reported Outcomes in Adults With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Trixeo Aerosphere™ in Routine Care Settings in Greece
