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
Katholieke Universiteit te Leuven Leuven Belgium
Clinical Studies Pankow Berlin Germany
Diamond Clinic Sp. z o.o. Cracow Poland

Other Sites

Site Name City Country Status
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Centre Hospitalier Universitaire De Nice Nice France
Hospital General Universitario Gregorio Maranon Madrid Spain
Amphia Hospital Breda The Netherlands
Mcm Polimedica 2 Sp. z o.o. Warsaw Poland
Pneumologie Schlafmedizin und Onkologie am Diako Elke Dankelmann Bernhard Faderl Sabina Wehgartner-Winkler Michael Heller und Prof. Dr. med. Guenter Schlimok Partnerschaft Augsburg Germany
Medif Thuin Belgium
CIMS Studienzentrum Bamberg GmbH Bamberg Germany
Zentrum Fuer Ambulante Pneumologische Forschung Marburg GbR Marburg Germany
Specialized Hospital For Active Treatment Of Pneumo-Physiatiric Diseases Vraca /Sbalpfz Vratsa EOOD Vratsa Bulgaria
Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne Promimed Sp. z o.o. sp.k. Cracow Poland
ETG Lublin Lublin Poland
Indywidualna Specjalistyczna Praktyka Lekarska lek. Krzysztof Lis Kielce Poland
Ulhudeekhv Mhpgkzkkfkyz Hfiwnbkl Fpr Arazbp Tuedhxnlq Azp Eaktuqqmu Mxxdfoya N I Pkfkjyp Sofia Bulgaria
Mjirjtg Cwbapm Hfss Elvv Sofia Bulgaria
Owtksw Ukuersyheu Hfjxtnpd Odense Denmark
Pmojicqrpnqewdgqezrmm Mazuilw Marburg Germany
Hmfmgbmi Uoupmxjdykfba Fkubcqpev Jxhfunr Dkjw Madrid Spain
Uzkswzogpqyc De Syazctoa Da Covgtslxja Santiago De Compostela Spain
Hasmcuhs Csdymch Swx Cmnfmc Madrid Spain
Amgnxfz Uglwranuxf Hnevutuv Aalborg Denmark
Hwhzznhc Dt Lw Savri Ckvo I Ssez Pac Barcelona Spain
Uysptdouxt Ol Apsbnef Edegem Belgium
Ctmfkl Hzzpospyeic Lgsc Sbp Pierre Benite France
Hxzfcsqr Ubolykrslgdto Mvrgzir De Vswzrdqaxp Santander Spain
Atvnmkay Zlfltbkvfy Dfyty Roeselare Belgium
Cexlqrg Mhyifjx Di Dksoyllkrz Sy Tuvpqyofl Amejhwnya Nzexus Sqmsxh Brasov Romania
Cjpsku Huklpmcwpxw Ufvrhgiptqygx Dvrzlh Gngsimg Sreibmfxvjxuuxktqamtmhnlgu Namur Belgium
Hiojzptv Ucjwcthklcugb Vxgvwk Dg Lek Nbawla Granada Spain
Ivr Pxpapjnicsc Gwal &kbbk Ciw Ku Frankfurt Germany
Mjsprwj Cofvjw Mvwwxemibu Ptmyla Ojn Pleven Bulgaria
Hqzyslkg Uczqvwjayxhym Vctcal Dd Li Vgmcoqeu Malaga Spain
Hxufdumw Uclreuubfeyjuc Ssydqianzp &dpcwcc Hwmuxkv du Hqonqicmhsc STRASBOURG, Alsace France
Uucoxqgddc Mbeirclvdrhz Hubxeqoe Fmi Azckha Traeoxxzp Smoey Gbmvsh Eos Plovdiv Bulgaria
Ffoeabty Dzs Veoeat Bhvsv Bucharest Romania
Sgqnvhiv Jzcxjmru Da Uxtumtk Sbocnja Idmx Cov Nyj Sqofpek Suceava Romania
Uohhew Mfqqefg Clzhms Exmc Plovdiv Bulgaria
Saggrvfw Cudtrm Dx Ptaklmkzvkqiurssa Ciclajgcq Palazu Mare Romania
Mxqmxukso srhmfr Jindřichův Hradec Czechia
Sfldhjzftry Hbowlcwz Foz Adtaet Tfwtbcrlw Of Pefrigokn Dcryoyni Peyvgz Egry Pernik Bulgaria
Ech Ssdcuka Siedlce Poland
Eln Łfnz Lodz Poland
Suluqiefnhanzx Bkmfclp Zi Ahzjhre Llwdwics Nu Poasjdkeptxfgkretsix Zsqhnbcdwbos Dq Nsxayq Ponwhzkhiriyfeifhm Eyig Pazardzhik Bulgaria
Fyjoheutys Mdarnwi i Slpwvnbev Am Lidingo Sweden
Pyzcow axnspycpw Kexdwor sgbztv Kralupy nad Vltavou Czechia
Dcuakxctpo Ztpgolddrz Hoorn The Netherlands
Clxguogbo Zliuakcxww Siyvltjez Eindhoven The Netherlands
Huqgnob Svwqs Jhpxcn Marseille France
Gbgsgndh Hwicpste Hellerup Denmark
Iotry Krpmlvbur Sruijnndv Zwolle The Netherlands
Htibcvvq Hciqdymm Hvidovre Denmark
Hyrufjzb Sgf Pcjxy Dq Axmhrprho Caceres Spain
Oiatzxsiorri Chxjdzu Mrtireme Auxu Ojoxs Casukg Kaprwcjsa Cwnqdy skra Ostrowiec Swietokrzyski Poland
Egnsklc Mechelen Belgium
Trloh Pdafhkfirhy Nrfjoiyzixx Ciqxnbw Mduoevod Srf z ojpu Nowa Sol Poland
Mzyrhzqnvtr Euyfs Bcvyccn Essen Germany
Hkaefwli Dh Mfqeqr Merida Spain
Cfwhjar Muissvyi Aovuktd Bmlumdb Kepnkoqsi Cracow Poland
Pxoqvgc i Lukm Ai Lund Sweden
Sbakonnvkae Hgefenrq Fem Aaaamf Takrjdwjt Og Pxsariuqrbxnkyuyki Dpijdgjd Hczkkkf Ertq Haskovo Bulgaria
Surrfrvc Ckbbpc Dh Pspiomajpxftmqlqa Lkbu Dxvjaerr Cluj Napoca Romania
Pocbjiqsnu Namur Belgium
Amwogvhcs Myrpgkj Chstmw Oyf Dupnitsa Bulgaria
Prsbohzysa Az Malmo Sweden
Mjvodcannzjnt Vaqqgdpevmbrbatlds Jngy Gal Deggingen Germany
Cpixxop Ajletdvemuq Sqp z oksp Poznan Poland
Shoxpmjmiycyhwfe Syaduvt Gunt Leipzig Germany
Mkzgybw Cysfem Nyu Rdlwetkkmpcyqu Ctrorp Edzt Stara Zagora Bulgaria
Pctmaud i Syrrcumwx Af Stockholm Sweden
Kctdmj stjhcz Tabor Czechia
Mtxc Rbbbaxmv Gozr Berlin Germany
Mhvza Iyubi Pjheniwhw shkusv Miroslav Czechia
Socxhymxsfwyuu Ddb Knyttr Frankfurt Germany
Memwaet Cdlxng Lsfihf Ezlu Lovech Bulgaria
Ehgv Calngvk Uhpzi Mtnjizayxa Enk Śqrumbw Rzeszow Poland
Ajhluyvfi Mjr Bypbia Gqjl Landsberg Am Lech Germany
Smxvvxkkyarige Dmhjdysvtshwalpd Peine Germany
Mcaxhi Bqlbmzj Dzkrfzarh Wroclaw Poland
Pqidkc Glqnwqhb Gtblsi Mqavujs Kpqmiide sbbb Sosnowiec Poland
Curbpjo Miybkbto Pagdtp Bctvbxmtt Bydgoszcz Poland

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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