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Ongoing Clinical Trials for Chronic Obstructive Pulmonary Disease

This article provides information about 40 ongoing clinical trials investigating new treatments for Chronic Obstructive Pulmonary Disease (COPD). These studies are testing various medications including biologic therapies, inhaled corticosteroids, bronchodilators, and other novel approaches aimed at reducing disease exacerbations, improving lung function, and enhancing quality of life for people living with COPD.

Clinical trial locations

Study of AZD6793 tablets to reduce flare-ups in adults with moderate to very severe chronic obstructive pulmonary disease (COPD)

This trial is investigating whether AZD6793 tablets can reduce the frequency of moderate to severe exacerbations in people with COPD. Participants must be at least 40 years old with moderate to very severe disease and a history of at least two moderate or one severe exacerbation in the past year. The study requires participants to have been using triple or dual inhaler therapy regularly for at least three months and have a CAT score of 10 or higher. Smoking history of at least 10 pack-years is also required. The trial will last 24 weeks and includes participants from Hungary, Poland, Bulgaria, Spain, Germany, Italy, Greece, and Denmark.

The main exclusion criteria include a history of asthma or other significant respiratory disorders besides COPD, current active lung infections, major surgery within three months, severe heart problems, liver or kidney disease, and recent participation in another clinical trial. Pregnant or breastfeeding women are also excluded from participation.

AZD6793 is a novel medication being tested specifically for its ability to reduce moderate to severe COPD exacerbations. It comes in tablet form and is taken by mouth. Throughout the study, researchers will monitor lung function, quality of life, and any side effects to understand both the effectiveness and safety of this treatment approach.

Study of Azithromycin Treatment Based on Mucus Changes in Patients with Chronic Obstructive Pulmonary Disease (COPD)

This French study examines a new approach to prescribing azithromycin based on analyzing mucus properties in COPD patients. The trial compares two methods over 12 months: prescribing based on standardized management versus based on mucus analysis. Participants must be between 40 and 85 years old with GOLD class C or D disease and have experienced at least three exacerbations of any severity in the past year or at least one severe exacerbation requiring hospitalization.

Key inclusion criteria include the ability to produce sputum naturally or through medical assistance and normal ECG results for age. Participants must also have no medical reasons preventing long-term azithromycin use. The study excludes patients under 18 or over 65 years, those with severe heart conditions, severe liver disease, current active infections, severe mental health conditions, and those unable to provide informed consent.

Azithromycin is a well-established antibiotic that also has anti-inflammatory properties beneficial in managing COPD. In this trial, it is used to prevent exacerbations and improve quality of life by reducing inflammation and controlling bacterial colonization in the airways when patients show signs of severe sputum production.

Study of psilocybin therapy for psychological distress in patients with COPD, ALS, multiple sclerosis, or atypical Parkinson's disorders

This innovative trial investigates psilocybin therapy for patients with serious medical conditions including COPD who are experiencing psychological distress. Conducted in Czechia, Netherlands, Denmark, and Portugal, the study tests different doses of psilocybin to assess its potential in reducing depression symptoms. Participants must have confirmed diagnosis of one of the specified conditions and major depressive disorder with a MADRS score higher than 19.

Eligibility requires being at least 18 years old with a life expectancy of at least six months and having an identified caregiver. For COPD patients specifically, participants must be 40 years or older with at least 10 years smoking history and specific breathing test results showing reduced lung function. The study excludes individuals with personal or family history of schizophrenia, psychosis, or bipolar disorder, recent suicide attempts, active substance abuse, severe heart conditions, or pregnancy.

Psilocybin is administered as oral capsules in different doses along with psychological support. The therapy aims to help patients process their experiences and potentially reduce depressive symptoms associated with living with serious medical conditions.

Study of Tezepelumab Compared to Placebo in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This trial evaluates whether tezepelumab can reduce COPD exacerbations in adults with moderate to very severe disease. Taking place across Slovakia, Czechia, Germany, Poland, Spain, Italy, and Denmark, the study involves 76 weeks of treatment with regular subcutaneous injections. Participants must be between 40 and 80 years old with at least 12 months of confirmed COPD and a history of either two moderate or one severe exacerbation in the past year.

Key requirements include using triple or dual therapy regularly for at least three months before enrollment, blood eosinophil count of at least 150 cells per microliter, and a CAT score of 15 or higher. Participants must also have smoking history equivalent to 10 pack-years. Exclusions include history of asthma, active lung infections, major recent surgery, unstable heart conditions, current cancer treatment, and severe liver or kidney disease.

Tezepelumab is a biologic medication that works by targeting thymic stromal lymphopoietin, a protein involved in airway inflammation. By blocking this inflammatory pathway, it aims to reduce the frequency of COPD exacerbations and improve patient outcomes.

Study of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) to Reduce Disease Flare-ups

This parallel study of tezepelumab is conducted across nine European countries including Hungary, Sweden, Bulgaria, Romania, Greece, Denmark, Belgium, Netherlands, and France. Like the previous tezepelumab trial, this 76-week study examines whether the medication can reduce exacerbations in adults aged 40 to 80 with moderate to very severe COPD.

Participants must have similar characteristics to the previous trial: at least 12 months of COPD diagnosis, use of triple or dual therapy for at least three months, history of at least two moderate or one severe exacerbation, blood eosinophil count of at least 150 cells per microliter, and CAT score of 15 or higher. Smoking history of at least 10 pack-years is required. The exclusion criteria are also similar, including asthma history, active infections, major surgery, severe cardiac conditions, and pregnancy.

The medication is administered through subcutaneous injection from pre-filled syringes. Throughout the study, researchers monitor lung function, exacerbation rates, quality of life measures, and any adverse events to comprehensively assess the treatment’s benefits and safety profile.

Study of Verekitug to improve symptoms in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

This large trial spanning 11 European countries investigates verekitug for reducing COPD exacerbations in patients with moderate-to-severe disease. The study lasts 108 weeks with participants receiving subcutaneous injections while continuing their regular COPD medications. Eligible participants must be between 40 and 85 years old with COPD diagnosis for more than 12 months and smoking history of at least 10 pack-years.

Inclusion criteria include having breathlessness rated as grade 2 or higher on the Modified Medical Research Council scale and experiencing either more than two moderate or at least one severe exacerbation in the past year. Participants must be taking triple therapy for at least three months with stable dosing for at least one month. The study requires at least 80% compliance with current medication during the screening period.

Exclusions include history of asthma or other significant lung diseases, current lung infection, major surgery within three months, severe heart disease, recent cancer treatment, participation in another trial within 30 days, and inability to follow study procedures. Verekitug is a novel investigational drug being evaluated primarily for its potential to reduce exacerbations in moderate-to-severe COPD.

Study on Atorvastatin for Reducing COPD Exacerbations in Smokers with Chronic Obstructive Pulmonary Disease

This Polish study explores whether atorvastatin, commonly used to lower cholesterol, can reduce COPD exacerbations through its anti-inflammatory properties. Participants must be at least 40 years old with at least 10 pack-years of smoking history and confirmed COPD diagnosis with specific airflow limitations measured by spirometry.

The study requires participants to have experienced at least two moderate or severe exacerbations or one requiring hospitalization in the past year. Participants must be clinically stable with no COPD worsening for at least four weeks before enrollment. The trial continues until December 2025, monitoring various health outcomes including lung function, symptom evaluation, and the frequency of exacerbations.

Atorvastatin belongs to the statin class of medications and works by blocking cholesterol production in the liver while also demonstrating anti-inflammatory properties. The study investigates whether these anti-inflammatory effects can benefit COPD patients by reducing airway inflammation and preventing exacerbations, potentially providing a new treatment approach beyond the medication’s traditional use.

Study on Budesonide for COPD Patients with Different Eosinophil Levels

This eight-week trial conducted in Netherlands, Spain, and Germany examines how budesonide affects patients with varying blood eosinophil levels. Participants must be between 40 and 85 years old with at least 10 pack-years smoking history and must have quit smoking for at least six months. The study requires specific lung function results and current use of dual long-acting bronchodilators for at least eight weeks.

Women of childbearing potential must have a negative pregnancy test and agree to use highly effective birth control methods during the study, avoiding hormonal methods due to potential side effects. The trial collects samples from sputum, nasal and throat swabs, urine, and blood to observe molecular changes in the microbiome and transcriptome.

Budesonide is an inhaled corticosteroid that reduces inflammation in the airways. This study specifically investigates how the medication affects patients with different severities of COPD and varying levels of eosinophils in their blood, providing insights into personalized treatment approaches based on inflammation markers.

Study on Dronabinol for Reducing Severe Breathlessness in Patients with Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD)

This Danish crossover trial tests whether dronabinol, a synthetic cannabis compound, can relieve severe breathlessness in patients with severe and very severe COPD. The four-week study requires participants to have refractory dyspnea with GOLD 3 or 4 classification and breathlessness score of 3 or higher on the mMRC scale. Participants must be between 18 and 64 years old, mentally capable, and able to understand and speak Danish.

Women of childbearing age must have a negative pregnancy test and use safe contraception during the study and for four weeks after. Exclusions include other serious health conditions, pregnancy, breastfeeding, current use of certain interfering medications, history of substance abuse or addiction, and recent participation in another clinical trial.

Dronabinol works by interacting with cannabinoid receptors in the brain, which can influence the perception of breathlessness. The medication is administered as oral capsules at a dose of 1 mg/ml. The study evaluates both the walking distance participants can manage and their perceived exertion using the Borg scale to assess whether this treatment can improve physical capacity in severe COPD.

Study on Oxygen Therapy and Drug Combination for Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease (COPD)

This Danish study compares standard oxygen therapy with targeted oxygen therapy adjusted based on patient needs before hospital arrival. The trial aims to determine if targeted oxygen therapy can reduce 30-day mortality in patients with acute COPD exacerbations. Participants must be over 40 years old with suspected COPD and require inhaled bronchodilators as determined by emergency medical personnel.

The study medications include Berodual containing fenoterol hydrobromide and ipratropium bromide, Salbutamol, and medicinal oxygen delivered through nebulizer or as compressed gas. Throughout the trial, researchers monitor survival rates at 24 hours, 7 days, and 30 days, along with other health indicators such as ICU admission needs and occurrence of respiratory acidosis.

The trial focuses on prehospital settings, evaluating whether adjusting oxygen levels earlier in treatment can improve outcomes. The study will follow participants to assess various outcomes including hospital length of stay and the need for additional breathing support like non-invasive or mechanical ventilation.

Summary

These 40 clinical trials represent diverse approaches to managing COPD, from novel biologic therapies like tezepelumab, benralizumab, and itepekimab to repurposed medications like atorvastatin and innovative therapies such as psilocybin for psychological distress. Many trials focus on reducing exacerbations, the primary concern for patients with moderate to severe disease. A significant number of studies are investigating medications targeting specific inflammatory pathways, particularly those involving eosinophils, suggesting an emerging understanding of COPD as a heterogeneous disease requiring personalized treatment approaches. Geographically, European countries show strong participation, with particular concentration of trials in Germany, Spain, and Denmark. Several studies are exploring combination therapies and optimizing existing treatments like inhaled corticosteroids and bronchodilators. The trials generally require participants with significant smoking history and documented exacerbation history, reflecting focus on patients with more severe disease who need additional treatment options beyond standard maintenance therapy.

Ongoing Clinical Trials on Chronic obstructive pulmonary disease

  • Study of Tezepelumab Compared to Placebo in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia Denmark Germany Italy Poland Slovakia +1

  • Study of dupilumab injections to reduce airway inflammation in adults aged 40-85 with chronic obstructive pulmonary disease

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Denmark France Germany Hungary Italy +4

  • Long-term Safety Study of Tozorakimab for Patients with Chronic Obstructive Pulmonary Disease and History of Exacerbations

    Recruiting

    1 1 1
    Investigated diseases:
    France

  • Study of budesonide, glycopyrronium and formoterol inhaler to evaluate heart and lung function in patients with chronic obstructive pulmonary disease and hyperinflation

    Recruiting

    1 1 1
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    Investigated drugs:
    Germany

  • Study of AZD6793 tablets to reduce flare-ups in adults with moderate to very severe chronic obstructive pulmonary disease (COPD)

    Recruiting

    1
    Investigated diseases:
    Bulgaria Denmark Germany Greece Hungary Italy +2

  • Study of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD) to Reduce Disease Flare-ups

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium Bulgaria Denmark France Greece Hungary +3

  • Study of Piperacillin/Tazobactam and Levofloxacin for Patients with COPD or Cystic Fibrosis

    Recruiting

    1 1 1 1
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    Investigated drugs:
    Austria

  • Study on Reducing Antibiotic Use in Severe COPD Exacerbation with Amoxicillin, Cefotaxime, and Ciprofloxacin for Patients on Mechanical Ventilation or Oxygen Therapy

    Recruiting

    1 1 1 1
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    France

  • Study on the Effects of Tezepelumab on Airway Inflammation in Patients with Chronic Obstructive Pulmonary Disease (COPD)

    Recruiting

    1 1
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    Denmark

  • Study on Dronabinol for Reducing Severe Breathlessness in Patients with Severe and Very Severe Chronic Obstructive Pulmonary Disease (COPD)

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark

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