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Ongoing Clinical Trials for Asthma

This article provides detailed information about ongoing clinical trials investigating new treatments for asthma, a chronic respiratory condition affecting millions of people worldwide. These studies are exploring various medications including biological therapies, inhalation treatments, and immunotherapies aimed at improving symptom control, reducing asthma attacks, and enhancing quality of life for patients with different types and severities of asthma.

Clinical trial locations

Long-term safety study of dexpramipexole tablets in patients with severe eosinophilic asthma who completed EXHALE-2 or EXHALE-3 trials

This ongoing study evaluates the long-term safety and tolerability of dexpramipexole in patients with severe eosinophilic asthma who have completed previous clinical trials (EXHALE-2 or EXHALE-3). The trial will be conducted across multiple European countries including Czechia, Germany, Poland, Bulgaria, Romania, and Spain.

Main inclusion criteria: Participants must have completed the treatment period in either EXHALE-2 or EXHALE-3 studies and continue their existing asthma medication regimen. Women of childbearing potential must use effective contraception and have negative pregnancy tests.

Main exclusion criteria: Patients who did not complete the previous trials or those with contraindications to continued treatment are excluded.

Trial focus: The study aims to monitor the safety profile of dexpramipexole over an extended period of 52 weeks. Participants receive 150 mg dexpramipexole twice daily and attend regular follow-up visits at weeks 16, 32, and 52 for assessments including blood tests, lung function measurements, ECG monitoring, and symptom evaluation.

Investigational drug: Dexpramipexole (KNS-760704) is an oral medication designed to reduce blood eosinophil levels by affecting eosinophil production and survival. This novel small molecule therapeutic is currently in Phase III clinical trials for severe eosinophilic asthma treatment.

Study of dupilumab added to inhaled corticosteroids and long-acting beta-agonists compared to high-dose inhaled therapy in adolescents and adults with uncontrolled asthma

This 52-week trial compares the effectiveness of adding dupilumab to medium-dose inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) therapy versus increasing to high-dose ICS/LABA in adolescents and adults with uncontrolled asthma. The study is being conducted in Poland, Germany, and Denmark.

Main inclusion criteria: Participants must be aged 12-80 years with documented moderate to severe asthma for at least 12 months. They should be using medium-dose ICS/LABA for at least 3 months with stable dosing for 1 month prior to enrollment. Patients must demonstrate at least 80% compliance with usual asthma medication and have an ACQ-6 score of 1.5 or higher, indicating poor asthma control.

Main exclusion criteria: Patients with other serious health conditions, pregnant or breastfeeding women, and those unable to comply with study procedures are excluded.

Trial focus: The study monitors participants’ lung function through breathing tests (FEV1 and FVC measurements), symptom questionnaires (ACQ-5), and home lung function monitoring. Participants receive either dupilumab 300 mg injections plus medium-dose ICS/LABA or high-dose ICS/LABA plus placebo injections.

Investigational drug: Dupilumab is a biologic medication administered through subcutaneous injection that works by blocking interleukin-4 and interleukin-13 proteins involved in allergic inflammation, thereby reducing airway inflammation and improving asthma control.

Study of Dupilumab’s Effect on Airway Mucus in Adults with Severe Asthma

This Austrian study investigates how dupilumab affects mucus accumulation in the airways of adults with severe asthma over a treatment period of 22 months.

Main inclusion criteria: Adults aged 18 or older with confirmed severe asthma diagnosis who have specific biomarkers including FeNO greater than 25 ppb, blood eosinophil counts of 250 cells/µL or higher on two occasions, or documented sputum/BAL eosinophils. Participants must have stable asthma treatment and be willing to participate in bronchoscopy procedures.

Main exclusion criteria: History of anaphylaxis to biological therapy, active parasitic infections, active tuberculosis, cancer within the past 5 years, significant liver disease, pregnancy or breastfeeding, and uncontrolled medical conditions are exclusions.

Trial focus: The study evaluates airway mucus formation through regular monitoring and CT scans. Participants receive subcutaneous injections of Dupixent (dupilumab) 300 mg using pre-filled syringes. Specific biomarker measurements are taken throughout the treatment period.

Investigational drug: Dupilumab (Dupixent) is a monoclonal antibody that targets interleukin-4 and interleukin-13 pathways involved in type 2 inflammation, helping to reduce mucus production and improve airway function in severe asthma patients.

Study of PF-07275315 to evaluate its effectiveness and safety in adults with moderate-to-severe asthma who have high levels of eosinophils in their blood

This 12-week trial evaluates the investigational medication PF-07275315 in adults with moderate-to-severe eosinophilic asthma across Hungary, Czechia, Poland, Bulgaria, Belgium, Spain, and Italy.

Main inclusion criteria: Participants must be aged 18-70 years with documented asthma for at least 12 months. They should have a lung function (FEV1) between 30-80% of predicted normal values and demonstrate reversibility of at least 12% and 200 mL after bronchodilator use. Patients must be using medium to high-dose ICS-LABA for at least 6 months with stable dosing for 3 months prior to screening. An ACQ-5 score of 1.5 or higher and history of asthma exacerbation in the previous year are required.

Main exclusion criteria: Current COPD diagnosis, life-threatening asthma in past 12 months, recent smoking history (quit less than 6 months ago), pregnancy or breastfeeding, significant heart problems, recent infections, and participation in other trials within 30 days are exclusions.

Trial focus: The study assesses lung function changes through regular FEV1 measurements at baseline and throughout the 12-week treatment period. Participants also complete asthma control questionnaires (ACQ-5 and AQLQ) to evaluate symptom improvement and quality of life.

Investigational drug: PF-07275315 is an investigational medication administered via subcutaneous injection being studied for its potential to reduce inflammation and improve lung function in patients with eosinophilic asthma, though the exact mechanism of action has not been fully disclosed in the available data.

Study of Tezepelumab effects on airway barrier function in patients with severe asthma, with or without chronic rhinosinusitis with nasal polyps

This Austrian study examines how tezepelumab affects the protective barriers in both upper and lower airways in patients with severe asthma, with or without chronic rhinosinusitis and nasal polyps. The treatment period lasts up to 4 months.

Main inclusion criteria: Participants must be aged 18-99 years with diagnosed severe asthma requiring treatment at step 4 or 5. They should have at least one indicator of poor control: ACT score less than 20, ACQ score above 0.75, two courses of oral corticosteroids in past 12 months, one hospitalization for asthma in past 12 months, or FEV1 less than 80% predicted. Patients must have FeNO ≥20 ppb and blood eosinophils ≥250/µL or other specified eosinophil criteria. Those with nasal polyps need confirmation via examination or CT scan, and all participants must have a mucus score of 1 or higher.

Main exclusion criteria: Age below 18 or above 65 years, pregnancy or breastfeeding, current smoking or quit within past 6 months, recent respiratory infections, systemic corticosteroid use in past 4 weeks, chronic lung diseases other than asthma, uncontrolled hypertension, significant organ disease, recent cancer, participation in other trials, allergies to tezepelumab, inability to perform breathing tests, mental conditions affecting compliance, and active autoimmune diseases are exclusions.

Trial focus: The study monitors airway barrier function through cell sampling and inflammation assessments. Participants receive tezepelumab injections with regular monitoring of lung function, inflammatory markers, and airway cell composition throughout the study continuing until January 2027.

Investigational drug: Tezepelumab is a monoclonal antibody administered via subcutaneous injection that blocks thymic stromal lymphopoietin (TSLP), a protein involved in airway inflammation, thereby reducing inflammatory responses and improving respiratory barrier function in severe asthma patients.

Study on Azithromycin for Treating Hospitalized Children Aged 1-5 with Asthma Symptoms

This Danish trial investigates whether azithromycin can reduce the duration of moderate asthma episodes in hospitalized children aged 1-5 years compared to placebo.

Main inclusion criteria: Children aged 12-71 months (1 to almost 6 years) with previous episodes of asthma-like symptoms treated with SABA alone or with ICS and possibly LTRA. The child must have a moderate asthma attack as measured by the Pulmonary Score and classified according to ICD10 and GINA 2024 guidelines. Parents or guardians must provide written informed consent, and for children 12 years or older, assent is also required. Parents must be fluent in Danish.

Main exclusion criteria: Children with severe asthma attacks or asthmatic crises that are not classified as moderate, those outside the specified age range, and members of vulnerable populations cannot participate.

Trial focus: Participants are randomized to receive either azithromycin or placebo for three days. Throughout the study, symptoms are monitored, hospital stay duration is recorded, and the need for additional medications (SABA or oral corticosteroids) is tracked. Parents maintain a symptom diary, and final assessments evaluate the medication’s effectiveness in reducing asthma episode duration.

Investigational drug: Azithromycin is a macrolide antibiotic administered orally that works by inhibiting bacterial protein synthesis. While primarily used for bacterial infections, this trial explores its potential to reduce inflammation and alleviate asthma symptoms during acute episodes in young children.

Study on Benralizumab for Patients with Severe Asthma

This French study evaluates benralizumab’s effects at a genetic level and its ability to reduce asthma exacerbations in patients with severe eosinophilic asthma over a 12-month period.

Main inclusion criteria: Adults aged 18-75 years with severe asthma documented for at least 12 months. Participants must be on high-dose ICS (>1000 micrograms per day of beclomethasone or equivalent) plus additional medications for over a year, with asthma still uncontrolled or worsening when medications are reduced. Patients need documented reversible airflow obstruction (FEV1 improvement of at least 12% and 200 mL), ACQ-7 score of 1.5 or higher, and at least 3 asthma exacerbations in the 12 months prior. Blood eosinophil count must be 0.3 G/L or higher at screening or in past 12 months (or 0.15-0.3 G/L with additional criteria). No previous benralizumab treatment is permitted, and written consent is required.

Main exclusion criteria: Patients without severe asthma, those outside the age range of 4-3 years (note: this appears to be a data error), and vulnerable populations are excluded.

Trial focus: The study involves administering Fasenra (benralizumab) 30 mg via subcutaneous injection with regular follow-up visits at M0, M3, M6, M9, and M12. Blood samples are collected to analyze gene expression and assess treatment response. Patients are categorized as responders, intermediate responders, or non-responders based on reduction in asthma exacerbations. The goal is to identify a predictive blood signature indicating likelihood of positive response.

Investigational drug: Benralizumab (Fasenra) is a monoclonal antibody that targets and blocks the interleukin-5 receptor on eosinophils, leading to their destruction and reducing airway inflammation in severe asthma patients.

Study on Extending Dosing Intervals of Mepolizumab and Dupilumab for Patients with Severe Asthma

This Dutch study investigates whether extending the dosing intervals of mepolizumab and dupilumab is feasible while maintaining asthma control in patients with severe asthma who have achieved stable disease control.

Main inclusion criteria: Patients must have severe asthma as the primary indication for treatment with mepolizumab (100 mg every 4 weeks) or dupilumab (300 mg every 2 weeks) for at least the past 6 months. Asthma must be stable with an ACQ score less than 1.5 and no severe exacerbations for at least 6 months. Good understanding of Dutch language is required.

Main exclusion criteria: Other types of asthma not classified as severe, patients outside specified age ranges, vulnerable populations, and those not meeting specific health criteria are excluded.

Trial focus: The BIRDIE trial evaluates biomarker-guided dosing interval extension by monitoring eosinophil levels for mepolizumab users and FeNO levels for dupilumab users. The primary endpoint is the number of injections received during the follow-up period. Regular monitoring of asthma control occurs throughout the study, which continues until September 2026.

Investigational drugs: Mepolizumab is a monoclonal antibody that inhibits interleukin-5 (IL-5), reducing eosinophil production and activation. Dupilumab is a monoclonal antibody that blocks interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways involved in inflammatory responses.

Study on Glycopyrronium Bromide for Children Aged 6-12 with Asthma

This trial evaluates the efficacy, pharmacokinetics, safety, and tolerability of glycopyrronium bromide in children aged 6 to less than 12 years with asthma across Spain, Bulgaria, Hungary, and Poland.

Main inclusion criteria: Children aged 6-12 years with asthma diagnosed for at least 6 months. Must be using stable doses of medium-dose ICS-LABA for at least 4 weeks before screening. Must demonstrate proper inhaler and spirometry technique and be able to use electronic diary. FEV1 should be between 60-90% of predicted normal value for children in this age group. Participants must show reversibility (10% improvement in FEV1 after bronchodilator use) and have ACQ-7 score of 1.5 or higher. At least one severe asthma exacerbation in past 12 months requiring systemic corticosteroids or hospitalization is required. Minimum weight of 16 kg is necessary.

Main exclusion criteria: Other significant lung diseases, recent respiratory infection, current smokers or those who quit less than 6 months ago, allergies to study medications, significant heart/liver/kidney disease, current participation in other trials, and inability to use inhaler properly are exclusions.

Trial focus: The study involves multiple treatment periods of two weeks each, with participants receiving various combinations including fluticasone propionate, salbutamol, glycopyrronium bromide, salmeterol xinafoate, or placebo. Lung function is assessed through FEV1 measurements at week 2 intervals, with crossover design allowing each participant to receive all treatments sequentially.

Investigational drug: Glycopyrronium (bromide) is a long-acting muscarinic antagonist (LAMA) administered via inhaler that blocks certain receptors in the lungs, helping to relax and widen air passages and making breathing easier for asthma patients.

Study on GSK5784283 for Adults Aged 18-75 with Uncontrolled Asthma

This phase 2b trial evaluates the anti-TSLP antibody GSK5784283 in adults with moderate-to-severe uncontrolled asthma across Germany, Romania, Bulgaria, Czechia, and Spain. The study lasts 52 weeks including follow-up.

Main inclusion criteria: Adults aged 18-75 years with asthma diagnosed for at least 12 months. Must be on high-dose ICS-LABA (or medium-high dose ICS alone or with LABA) at stable dose for at least 3 months. Participants need pre-bronchodilator FEV1 between 40-85% predicted (children 12-17: 60-100%), ACQ-6 score ≥1.5, and history of at least one severe exacerbation in past year. Must show reversibility (≥12% and 200 mL FEV1 improvement after bronchodilator) and have blood eosinophils ≥300 cells/µL and/or FeNO ≥25 ppb. Minimum weight 40 kg required.

Main exclusion criteria: Pregnancy or breastfeeding, recent infections requiring antibiotics, cancer in past 5 years, current participation in other trials, known allergies to study medication, history of severe side effects from allergy treatments, uncontrolled asthma, other significant medical conditions, and inability to comply with study procedures are exclusions.

Trial focus: Three dose levels of GSK5784283 are evaluated via subcutaneous injection every 4 weeks. Primary focus is on the mean change in FeNO from baseline during weeks 20-26 and at week 26. Secondary endpoints include lung function changes, asthma control (ACQ-5), and quality of life assessments. Regular monitoring occurs throughout the 52-week period with final follow-up assessments.

Investigational drug: GSK5784283 is an anti-TSLP (thymic stromal lymphopoietin) antibody administered via subcutaneous injection that targets a protein involved in the inflammation process, potentially reducing asthma symptoms by modulating immune pathways associated with airway inflammation.

Study on Reducing Asthma Medication with Tezepelumab in Patients Aged 12 to 80 with Severe Asthma

This trial investigates whether patients with severe asthma who achieve control on tezepelumab can successfully reduce their background asthma therapy while maintaining asthma control. The study is conducted across Germany, Bulgaria, Denmark, France, Belgium, Spain, and Italy over 56 weeks.

Main inclusion criteria: Participants aged 12-80 years (or legal age of consent) with physician-diagnosed asthma for at least 12 months. Must be on medium-to-high dose ICS with another controller medication (LABA, LTRA, LAMA, or theophylline) at stable doses for at least 1 month. Pre-bronchodilator FEV1 must be ≤80% predicted at screening and baseline. ACQ-5 score must be ≥1.5 at screening and baseline. Participants must show variable airflow obstruction through documented reversibility tests, bronchial challenge, peak flow variability, or FEV1 variability. FeNO ≥35 ppb at baseline is required. History of at least one severe exacerbation in previous year is necessary.

Main exclusion criteria: Other serious lung diseases, recent severe asthma attack requiring hospitalization, current use of medications interfering with study treatment, history of severe allergic reactions to similar treatments, other medical conditions affecting study outcomes, pregnancy or breastfeeding, and recent participation in other clinical trials are exclusions.

Trial focus: Participants receive tezepelumab 210 mg subcutaneous injections once every 4 weeks. At week 24, asthma control is assessed. If control is achieved, there is potential to reduce background asthma therapy. The study continues for 56 weeks total, with regular assessments of asthma control and monitoring for exacerbations. The goal is to determine if successful reduction of daily asthma medication is possible while maintaining control with tezepelumab.

Investigational drug: Tezepelumab is a monoclonal antibody administered subcutaneously that blocks thymic stromal lymphopoietin (TSLP), a protein playing a key role in airway inflammation, thereby helping to control severe asthma symptoms and reduce exacerbations.

Summary

The clinical trial landscape for asthma demonstrates a strong focus on biological therapies and targeted treatments, particularly for patients with severe or uncontrolled disease. Several notable patterns emerge from these trials:

Geographic distribution: The trials show significant concentration in Central and Eastern European countries, with Poland, Germany, Spain, and Romania featuring prominently as study locations. France, Italy, and Bulgaria also host multiple trials, reflecting robust clinical research infrastructure in these regions.

Therapeutic approaches: The trials predominantly investigate monoclonal antibody therapies targeting specific inflammatory pathways. Dupilumab, tezepelumab, mepolizumab, and benralizumab appear frequently, reflecting the shift toward precision medicine approaches based on biomarker profiles. Several studies focus on eosinophilic asthma phenotypes, recognizing this as a distinct treatable trait.

Novel developments: Emerging medications like dexpramipexole, AZD4604, GSK5784283, and amlitelimab represent investigational compounds at various development stages, potentially expanding future treatment options. Studies also explore treatment optimization strategies, including extending dosing intervals for established biologics and evaluating steroid reduction protocols.

Patient populations: While many trials focus on adults, several specifically address pediatric populations, including adolescents (12-17 years) and younger children (1-11 years), acknowledging the need for age-appropriate asthma management strategies. Trials targeting severe, uncontrolled asthma despite standard therapy represent a significant proportion, addressing an important unmet medical need.

Treatment goals: Beyond reducing exacerbations, trials increasingly emphasize quality of life improvements, lung function preservation, reduction in corticosteroid dependency, and achievement of clinical remission. Studies investigating airway remodeling and mucus production represent efforts to address underlying disease mechanisms rather than just symptoms.

These ongoing trials collectively aim to refine asthma treatment through personalized approaches, improve long-term outcomes, and reduce treatment burden for patients with this chronic respiratory condition.

Ongoing Clinical Trials on Asthma

  • Study on the Effects and Safety of Dupilumab for Children Aged 2 to Under 6 with Uncontrolled Asthma or Severe Asthmatic Wheeze

    Not recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Czechia France Germany Greece Hungary Italy +3

  • Study on Asthma Control and Adherence with Mepolizumab in Pre-filled Devices for Patients with Asthma

    Not recruiting

    3 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Long-Term Safety and Efficacy of Amlitelimab for Adults with Moderate to Severe Asthma

    Not recruiting

    2 1 1
    Investigated diseases:
    Investigated drugs:
    Hungary Italy Poland

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