Real-World COPD study tracks benefits of switching to triple inhaler
NCT ID NCT05915182
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study followed 212 adults with moderate to severe COPD in Greece who were prescribed a triple-combination inhaler (Trixeo Aerosphere). Researchers tracked why patients switched from dual therapy and how their symptoms and quality of life changed over 52 weeks. The goal was to see if the switch helps in everyday medical practice, not just in controlled trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Budesonide, Glycopyrronium bromide, Formoterol fumarate (Trixeo Aerosphere inhaler)
- What this could lead to
- If successful, this study could show that switching to triple therapy improves daily life for COPD patients in real-world settings, helping doctors make better treatment decisions.
- What could go wrong
- This is an observational study, not a controlled trial, so results may be influenced by other factors. It is also small (212 people) and limited to Greece, so findings may not apply everywhere.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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212 people
The number who actually took part.
- Started
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Jul 2023
- Finished
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Mar 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Population from private practices and hospital clinics specializing in the management of Chronic Obstructive Pulmonary Disease (COPD) in geographically diverse locations throughout Greece, with a balanced representation of public, academic and private sector in Greece
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site
Alexandroupoli, 68100, Greece
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Research Site
Athens, 11521, Greece
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Research Site
Athens, 11527, Greece
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Research Site
Athens, 12462, Greece
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Research Site
Athens, 17562, Greece
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Research Site
Corfu, 49100, Greece
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Research Site
Crete, 71409, Greece
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Research Site
Crete, 71500, Greece
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Research Site
Crete, 73300, Greece
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Research Site
Ioannina, 45500, Greece
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Research Site
Larissa, 41110, Greece
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Research Site
Pátrai, 26332, Greece
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Research Site
Pátrai, 26504, Greece
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Research Site
Thessaloniki, 56429, Greece
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Research Site
Thessaloniki, 57010, Greece
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