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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

5 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Astegolimab – Astegolimab is administered via injection and is currently being studied in clinical trials for its potential use in treating Chronic Obstructive Pulmonary Disease (COPD). It is not yet widely available in medical practice, as it is still under investigation to determine its efficacy and safety. The main therapeutic indication for astegolimab is to reduce the frequency of moderate and severe exacerbations in patients with COPD. At the molecular level, astegolimab works by targeting and modulating specific immune pathways involved in inflammation. It is classified pharmacologically as a monoclonal antibody.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507093-40-00Protocol codeGB43311Estimated enrolment1 440 patientsSponsorGenentech Inc.

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