This clinical trial is focused on studying the effects of a treatment called Astegolimab in patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a long-term lung disease that makes it hard to breathe. The study aims to evaluate how well Astegolimab works in reducing the number of moderate and severe flare-ups of COPD over a year of treatment. Astegolimab is a type of medication known as a monoclonal antibody, which is a protein designed to target specific substances in the body.
Participants in the study will receive either Astegolimab or a placebo. The study will last for 52 weeks, during which the effects of the treatment on COPD symptoms will be closely monitored. The study will also look at how the treatment affects the quality of life of the participants, using a questionnaire designed to measure respiratory health. Additionally, the study will assess changes in lung function and the occurrence of any side effects.
Throughout the study, participants will continue their usual COPD maintenance therapy, which may include medications like inhaled corticosteroids, long-acting beta2-agonists, and long-acting muscarinic antagonists. The goal is to see if adding Astegolimab to these standard treatments can provide additional benefits in managing COPD. The study will also measure the levels of Astegolimab in the blood and check for any immune responses to the drug.
1joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (40-90 years), a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 12 months, and a history of frequent exacerbations.
Participants must have a history of smoking and be on stable COPD maintenance therapy.
2initial assessment
An initial assessment is conducted to establish baseline health status. This includes measuring lung function and quality of life using specific questionnaires.
3treatment phase
Participants are randomly assigned to receive either Astegolimab or a placebo. The treatment is administered over a period of 52 weeks.
The primary goal is to evaluate the effect on the annualized rate of moderate and severe COPD exacerbations.
4ongoing monitoring
Throughout the 52-week treatment period, participants are monitored for any changes in health status, including lung function and quality of life.
Regular assessments are conducted to track the time to first exacerbation and any adverse events.
5final assessment
At the end of the treatment period, a final assessment is conducted to measure changes from baseline in lung function and quality of life.
The presence of any anti-drug antibodies is also evaluated.
Who Can Join the Study?
Age between 40 and 90 years.
Have a documented diagnosis of Chronic Obstructive Pulmonary Disease (COPD) for at least 12 months. COPD is a lung condition that makes it hard to breathe.
Have a history of frequent exacerbations, which means having had two or more moderate or severe flare-ups of COPD symptoms within a 12-month period in the 24 months before the study starts.
Have a post-bronchodilator FEV1 between 20% and less than 80% of the predicted normal value at screening. FEV1 is a measure of how much air you can forcefully exhale in one second after using a bronchodilator, a medicine that helps open your airways.
Be a current or former smoker with a history of smoking at least 10 pack-years. A pack-year is a way to measure how much someone has smoked over time, calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked.
Have a history of using one of the following combinations of stable COPD maintenance therapy for at least 4 weeks before the study, with no expected changes in therapy before starting the study drug and throughout the study:
Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA). These are medicines that help reduce inflammation and open the airways.
Long-acting muscarinic antagonist (LAMA) plus LABA. These are medicines that help relax and open the airways.
ICS plus LAMA plus LABA.
Who Cannot Join the Study?
Patients who do not have Chronic Obstructive Pulmonary Disease (COPD) cannot participate. COPD is a long-term lung disease that makes it hard to breathe.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it usually means certain age groups are targeted.
Patients who are not part of the specified clinical trial groups cannot participate. This means only certain groups of people are included in the study.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are considered part of a vulnerable population may not be able to participate. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
University Multiprofile Hospital For Active Treatment And Emergency Medicine N I Pirogov
Sofia
Bulgaria
Medical Center Hera EOOD
Sofia
Bulgaria
UNIMED Medical Center EOOD
Plovdiv
Bulgaria
Isala Klinieken Stichting
Zwolle
The Netherlands
Hospital General Universitario Gregorio Maranon
Madrid
Spain
Amphia Hospital
Breda
The Netherlands
Algemeen Ziekenhuis Delta
Roeselare
Belgium
Hospital San Pedro De Alcantara
Caceres
Spain
Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o.
Nowa Sol
Poland
Medizentrum Essen Borbeck
Essen
Germany
Hospital Universitario Virgen De Las Nieves
Granada
Spain
CIMS Studienzentrum Bamberg GmbH
Bamberg
Germany
Hospital De Merida
Merida
Spain
Centrum Medyczne All-Med Badania Kliniczne
Cracow
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
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD
Vratsa
Bulgaria
Pneumocare
Namur
Belgium
Asclepius Medical Center OOD
Dupnitsa
Bulgaria
PharmaSite AB
Malmo
Sweden
Medizinisches Versorgungszentrum Jung GbR
Deggingen
Germany
ProbarE i Stockholm AB
Stockholm
Sweden
MediTrial s.r.o.
Jindřichův Hradec
Czechia
Salvus-Klinische Studien GmbH
Leipzig
Germany
MECS Research GmbH
Berlin
Germany
Medical Center New Rehabilitation Center EOOD
Stara Zagora
Bulgaria
MUDr. Ilona Pavlisova s.r.o.
Miroslav
Czechia
Kasmed s.r.o.
Tabor
Czechia
Medif
Thuin
Belgium
IKF Pneumologie GmbH & Co. KG
Frankfurt
Germany
University Multiprofile Hospital For Active Treatment Saint Georgi EAD
Plovdiv
Bulgaria
Spitalul Judetean De Urgenta Sfantul Ioan Cel Nou Suceava
Suceava
Romania
Odense University Hospital
Odense
Denmark
Catharina Ziekenhuis Stichting
Eindhoven
The Netherlands
Philipps-Universitaet Marburg
Marburg
Germany
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Spain
Sygehus Lillebaelt Vejle Sygehus
Vejle
Denmark
Universidade De Santiago De Compostela
Santiago De Compostela
Spain
Aalborg University Hospital
Aalborg
Denmark
Mcm Polimedica 2 Sp. z o.o.
Warsaw
Poland
Hopital Saint Joseph
Marseille
France
Centre Hospitalier Universitaire De Nice
Nice
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
Gentofte Hospital
Hellerup
Denmark
Centre Hospitalier Lyon Sud
Pierre Benite
France
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Namur
Belgium
Dijklander Ziekenhuis
Hoorn
The Netherlands
Medical Center Lovech EOOD
Lovech
Bulgaria
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k.
Cracow
Poland
Hospital Universitario Virgen De La Victoria
Malaga
Spain
Studienzentrum Dr.med.Schlenska
Peine
Germany
MICHAŁ BOGACKI DOBROSTAN
Wroclaw
Poland
Pulmag Grzegorz Gąsior Marzena Kociołek s.c.
Sosnowiec
Poland
Centrum Medyczne Pratia Bydgoszcz
Bydgoszcz
Poland
ETG Lublin
Lublin
Poland
Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof Lis
Kielce
Poland
Diamond Clinic Sp. z o.o.
Cracow
Poland
Fbomtscv Dfv Vyshdq Bwysp
Bucharest
Romania
Skkcxzxu Ckvyaf Do Pvsworlfvfppetcys Cpwidvosv
Palazu Mare
Romania
Hyethnya Hewzzbyx
Hvidovre
Denmark
Hvmimajy Ualptethedlkl Mviudpl Db Vxucacjaxt
Santander
Spain
Cqqzhrv Mkutpeb Dp Dtkjypypad Sk Tqwhfrafd Avexwsqnz Nkwofp Sbtsqx
Scfbkahzfpc Hwoakivh Ftz Afqezd Tfmeunhhk Od Prujiswgd Dqatbybt Prmkio Ephy
Pernik
Bulgaria
Fiqpadcqxx Miikeow i Sdpepbnxw Ag
Lidingo
Sweden
Pfczfa avnbxxrwq Kspdrlm szmsho
Kralupy nad Vltavou
Czechia
Ezg Skewoux
Siedlce
Poland
Ecc Łwfb
Lodz
Poland
Sppachopkhj Hfskgzbk Fpc Awdaag Trraoayqk Om Plrmmbdsetahrtarwc Dbjjaoek Hyfwvqc Ewdl
Haskovo
Bulgaria
Csdhjgx Aupkrzpkprq Sdt z ofoc
Poznan
Poland
Honaqbcr Dw Lc Sbppv Cfxx I Svwx Pbu
Barcelona
Spain
Umhfqgobnj Ox Awnbqtw
Edegem
Belgium
Slfkzxrbpcehfu Dby Kkwudg
Frankfurt
Germany
Mlpmjiq Cfpwrd Mupsckqpyr Pijlih Oum
Pleven
Bulgaria
Este Cvixdnr Uwwax Mjgkhoomiv Eiw Śacztkp
Rzeszow
Poland
Awocrinqj Mee Bgpcbv Gnue
Landsberg Am Lech
Germany
Hbomdcuj Uinexheftdfouv Ssbzlwfiay &whpmyv Htqgsmi dv Hwsykgtwosx
STRASBOURG, Alsace
France
Want to learn more about this study or check if you can participate? Contact us.
Trial status
Country
Status
Recruitment Start
Belgium
Not recruiting
01.02.2022
Bulgaria
Not recruiting
01.02.2022
Czechia
Not recruiting
01.02.2022
Denmark
Not recruiting
01.02.2022
France
Not recruiting
01.02.2022
Germany
Not recruiting
01.02.2022
Poland
Not recruiting
01.02.2022
Romania
Not recruiting
01.02.2022
Spain
Not recruiting
01.02.2022
Sweden
Not recruiting
01.02.2022
The Netherlands
Not recruiting
01.02.2022
Trial locations
Astegolimab is a medication being studied for its potential to help patients with Chronic Obstructive Pulmonary Disease (COPD). The trial aims to see if astegolimab can reduce the number of moderate and severe flare-ups of COPD symptoms over a year of treatment.
Chronic Obstructive Pulmonary Disease (COPD) – A chronic inflammatory lung disease that causes obstructed airflow from the lungs. It is characterized by long-term breathing problems and poor airflow, primarily due to the breakdown of lung tissue and small airways. Symptoms include breathing difficulty, cough, mucus production, and wheezing. The disease progresses over time, with periods of exacerbations where symptoms become worse than the usual day-to-day variation. These exacerbations can be triggered by infections or environmental pollutants. COPD is often caused by long-term exposure to irritating gases or particulate matter, most often from cigarette smoke.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.