This clinical trial is focused on studying Chronic Obstructive Pulmonary Disease (COPD), a long-term lung condition that makes it hard to breathe. The study will evaluate the effectiveness of a new treatment using a combination of medications delivered through an inhaler. The medications being tested include Budesonide, Glycopyrronium Bromide, and Formoterol Fumarate Dihydrate, which are combined in a product called Trixeo Aerosphere. This combination is compared to another inhaler treatment called Bevespi Aerosphere, which contains Glycopyrronium Bromide and Formoterol Fumarate Dihydrate. Additionally, the study involves the use of Salbutamol, a common medication for relieving breathing difficulties.
The purpose of the study is to assess how well these treatments work in improving heart and lung health in people with COPD. Participants will be randomly assigned to receive one of the treatments or a placebo. The study will last for up to 36 months, during which participants will use the inhalers as directed and attend regular check-ups to monitor their health. The study aims to determine the time it takes for participants to experience severe heart or lung-related events, such as worsening of COPD symptoms or heart problems.
Throughout the study, participants will be closely monitored to ensure their safety and to gather information on how the treatments affect their condition. The results of this study will help to understand the benefits and risks of using these inhaler medications for managing COPD and improving overall heart and lung health.
1joining the study
Upon joining the study, participants are required to demonstrate the correct technique for using a metered-dose inhaler (MDI) during the initial visits.
Participants must be between 40 to 80 years old and have a confirmed diagnosis of chronic obstructive pulmonary disease (COPD).
2initial assessment
An initial assessment includes a blood test to measure eosinophil count and a COPD assessment test (CAT) score.
Participants must have a history of smoking and meet specific cardiovascular risk criteria.
3randomization
Participants are randomly assigned to receive either the combination triple therapy or the dual bronchodilator therapy.
The combination therapy includes budesonide, glycopyrronium, and formoterol fumarate, while the dual therapy includes glycopyrronium and formoterol fumarate.
4treatment administration
Participants use the assigned inhalation therapy daily as per the study protocol.
The combination therapy is administered as Trixeo Aerosphere, and the dual therapy as Bevespi Aerosphere, both via inhalation.
5ongoing monitoring
Participants attend regular visits, either in-person or virtually, to monitor their health and the effects of the treatment.
The study aims to evaluate the time to the first severe cardiac or COPD event, among other health outcomes.
6completion of study
The study is expected to conclude by March 2028, with participants continuing their assigned treatment until the end of the study period.
Final assessments will be conducted to evaluate the overall impact of the treatment on cardiopulmonary outcomes.
Who Can Join the Study?
Participants must be between 40 and 80 years old.
Participants must be willing to visit the study site or join virtual visits as needed to complete all study assessments.
Participants must show they can use an MDI (Metered Dose Inhaler) correctly at the first two visits.
Females can join if they are either unable to have children (permanently sterilized or post-menopausal) or if they can have children, they must have a negative pregnancy test and use a highly effective birth control method.
Participants must be able to give signed informed consent, agreeing to follow the study’s requirements and restrictions.
Participants must have a confirmed diagnosis of COPD (Chronic Obstructive Pulmonary Disease) with specific lung function test results.
Participants must be current or former smokers with a history of smoking at least 10 pack-years. This means the number of cigarettes smoked per day divided by 20, multiplied by the number of years smoked. Former smokers must have quit at least 6 months before the first visit.
Participants must have a certain level of eosinophils (a type of white blood cell) in their blood, measured at the first visit.
Participants must have a CAT (COPD Assessment Test) score of 10 or higher at the first visit.
Participants must meet at least one of the following cardiovascular (heart and blood vessel) disease or risk factor criteria:
Have established cardiovascular disease.
Have a combination of cardiovascular risk factors such as high blood pressure, diabetes, chronic kidney disease, abnormal cholesterol levels, or obesity.
Be at high risk of cardiovascular disease based on a risk assessment tool.
Have coronary artery calcification seen on a CT scan.
Participants must be willing and able, according to the investigator, to adjust their current COPD treatment as required by the study protocol.
Who Cannot Join the Study?
Patients with a history of severe heart or lung problems that are not related to Chronic Obstructive Pulmonary Disease (COPD).
Patients who have had a recent heart attack or stroke.
Patients with uncontrolled high blood pressure.
Patients with a history of severe allergic reactions to medications.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding.
Patients with a history of drug or alcohol abuse.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate.
Specjalistyczna Przychodnia Lekarska Alergo Med Sp. z o.o.
Poznan
Poland
Centrum Medycyny Oddechowej Mroz Sp. j.
Bialystok
Poland
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR
Marburg
Germany
ProbarE i Lund AB
Lund
Sweden
Spitalul Clinic De Pneumoftiziologie Leon Daniello
Cluj Napoca
Romania
Lekarze Specjalisci J. Malolepszy I Partnerzy
Wroclaw
Poland
Policum Berlin Studien GmbH
Berlin
Germany
Specialized Hospital For Active Treatment Of Pneumo-Phthisiatric Diseases Dr. Dimitar Gramatikov-Ruse
Ruse
Bulgaria
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD
Vratsa
Bulgaria
Pneumo Studien Darmstadt GmbH
Darmstadt
Germany
Athens Naval Hospital
Athens
Greece
Asclepius Medical Center OOD
Dupnitsa
Bulgaria
Multiprofile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte
Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD
Pleven
Bulgaria
Cardio D&R s.r.o. Kosice
Kosice
Slovakia
Skedsmo Medisinske Senter AS
Skedsmokorset
Norway
IKF Pneumologie GmbH & Co. KG
Frankfurt
Germany
MediTrial s.r.o.
Jindřichův Hradec
Czechia
Multimedica S.p.A.
Milan
Italy
Centro De Salud Cabra Matrona Antonia Mesa Fernandez
Cabra
Spain
Giromed Institute S.L.P.
Barcelona
Spain
Hopital Europeen Marseille
Marseille
France
Centre Hospitalier Du Pays D Aix Centre Hospitalier Intercommunal Aix-Pertuis
Aix En Provence
France
Centre Hospitalier Public Du Cotentin
Cherbourg-En-Cotentin
France
Erzsebet Gondozohaz Kft.
Godollo
Hungary
MEDICON a.s.
Prague
Czechia
Nemocnice Tabor a.s.
Tabor
Czechia
Thermi Clinic S.A.
Thessaloniki
Greece
B&R Clinical Sp. z o.o.
Kielce
Poland
Pro Familia Altera Sp. z o.o.
Katowice
Poland
Centrum Diagnostyczno Terapeutyczne Medicus Sp. z o.o.
Lubin
Poland
Multi-Profile Hospital For Active Treatment Dr. Stamen Iliev AD
Montana
Bulgaria
Romed Klinikum Rosenheim
Rosenheim
Germany
MECS Research GmbH
Berlin
Germany
MECS Medical and Clinical Studies Cottbus GmbH
Cottbus
Germany
Krankenhaus Bethanien gGmbH
Solingen
Germany
Framol-Med GmbH
Rheine
Germany
Region Uppsala
Uppsala
Sweden
Obudai Egeszseguegyi Centrum Kft.
Dunaújváros
Hungary
Region Halland
Varberg
Sweden
Centre Hospitalier De Cannes Simone Veil
Cannes
France
University Of Debrecen
Debrecen
Hungary
Velocity Clinical Research Luebeck GmbH
Luebeck
Germany
Diagnostic Consultative Centre Ascendent OOD
Sofia
Bulgaria
Spitalul Clinic Judetean De Urgenta Bihor
Oradea
Romania
Hospital of Infectious Diseases and Pneumology Victor Babes, Timisoara
Timisoara
Romania
Matrai Gyogyintezet
Gyongyos
Hungary
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD
Sofia
Bulgaria
Capio La Croix Du Sud
Quint-Fonsegrives
France
University General Hospital Of Ioannina
Ioannina
Greece
Bugbox & Med. Co. Kft.
Budapest
Hungary
Vestre Viken HF
Drammen
Norway
Fondazione IRCCS Policlinico San Matteo
Pavia
Italy
Region Skane Skanes Universitetssjukhus
Lund
Sweden
Universita’ Campus Bio-medico Di Roma
Rome
Italy
Karolinska University Hospital
Solna
Sweden
Hospital Universitario De Cruces
Barakaldo
Spain
IRCCS Ospedale Policlinico San Martino
Genoa
Italy
Sygehus Lillebaelt Vejle Sygehus
Vejle
Denmark
Universidade De Santiago De Compostela
Santiago De Compostela
Spain
Aalborg University Hospital
Aalborg
Denmark
Institutul De Pneumoftiziologie Marius Nasta
Bucharest
Romania
Pratia S.A.
Skorzewo
Poland
General University Hospital Of Patras
Patras
Greece
Siteworks GmbH
Hanover
Germany
Klinische Forschung Berlin GbR
Berlin
Germany
Tuedogyogyintezet Toeroekbalint
Torokbalint
Hungary
Allergo-Fot Kft.
Szazhalombatta
Hungary
Akardo AB
Stockholm
Sweden
Maresme
Mataró
Spain
Centre Hospitalier Bretagne Atlantique
Vannes
France
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft
Augsburg
Germany
Koch Robert Korhaz Es Rendelointezet
Edeleny
Hungary
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Mulhouse
France
Regia Med Kft.
Szekesfehervar
Hungary
Satucon Oy
Kuopio
Finland
Berufsausuebungsgemeinschaft Bag Prof Dr. Med Gerhard Hoheisel Dr. Med Andreas Bonitz GbR
Budesonide is a medication used in this trial as part of a combination therapy. It is a type of steroid that helps reduce inflammation in the lungs, making it easier to breathe for people with chronic obstructive pulmonary disease (COPD).
Glycopyrronium is included in both the combination and dual therapies in this trial. It is a bronchodilator, which means it helps open up the airways in the lungs, making breathing easier for patients with COPD.
Formoterol Fumarate is another medication used in both the combination and dual therapies. It is a long-acting bronchodilator that helps relax muscles in the airways to improve breathing in people with COPD.
Chronic Obstructive Pulmonary Disease (COPD) – This is a long-term lung disease that makes it hard to breathe. It is characterized by a persistent blockage of airflow from the lungs, leading to breathing difficulties. The disease progresses slowly and is often caused by long-term exposure to irritating gases or particulate matter, most commonly from cigarette smoke. Over time, symptoms such as chronic cough, mucus production, and wheezing may worsen. As the disease advances, individuals may experience increased breathlessness and fatigue. COPD can lead to frequent respiratory infections and may significantly impact daily activities.
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