Study on the Effects of Astegolimab and Drug Combination for Patients with Chronic Obstructive Pulmonary Disease (COPD)

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What is this study about?

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.

1 joining 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.

2 initial assessment

An initial assessment is conducted to establish baseline health status. This includes measuring lung function and quality of life using specific questionnaires.

3 treatment 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.

4 ongoing 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.

5 final 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Clinical Studies Pankow Berlin Germany
Hospital Clinico San Carlos Madrid Spain
Katholieke Universiteit te Leuven Leuven Belgium

Other Sites

Site Name City Country Status
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 Brasov Romania
Odlnuufkqdnl Ctfgeho Mnrhqswp Agng Oytbi Chgsvv Khipburoa Cdhhcq slwf Ostrowiec Swietokrzyski Poland
Ejhmmps Mechelen Belgium
Snseskdgufcgrg Blhavpx Zx Auneeqp Lzjcygnd Nc Psexfanifubddrjcldeu Zlghuvqbswyi Db Nvkbkq Pdcbtgnettlltxvcae Eawu Pazardzhik Bulgaria
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 Belgium
Not recruiting
01.02.2022
Bulgaria Bulgaria
Not recruiting
01.02.2022
Czechia Czechia
Not recruiting
01.02.2022
Denmark Denmark
Not recruiting
01.02.2022
France France
Not recruiting
01.02.2022
Germany Germany
Not recruiting
01.02.2022
Poland Poland
Not recruiting
01.02.2022
Romania Romania
Not recruiting
01.02.2022
Spain Spain
Not recruiting
01.02.2022
Sweden Sweden
Not recruiting
01.02.2022
The Netherlands 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.

Trial ID:
2023-507093-40-00
Protocol code:
GB43311
Trial Phase:
Therapeutic exploratory (Phase II)

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