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Study on the Effectiveness and Safety of AZD4604 for Adults with Moderate-to-Severe Asthma Uncontrolled on Medium-High Dose ICS-LABA

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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 new treatment for asthma, specifically in adults who have moderate to severe asthma that is not well controlled with their current medication. The treatment being tested is called AZD4604, which is administered as an inhalation powder. The study aims to evaluate how effective and safe AZD4604 is when taken twice daily over a period of twelve weeks.

Participants in the study will be randomly assigned to receive either AZD4604 or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are unbiased. The main goal is to see if AZD4604 can improve asthma symptoms and reduce the frequency of asthma attacks compared to the placebo.

Throughout the study, participants will have regular check-ups to monitor their asthma symptoms and overall health. The study will track changes in lung function and asthma control over the twelve-week period. By the end of the study, researchers hope to gather valuable information about the potential benefits of AZD4604 for people with moderate to severe asthma.

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 specific criteria such as age, asthma severity, and treatment history.

    Participants must be between 18 and 80 years old and have a documented history of moderate-to-severe asthma that is not well controlled with current medication.

  2. Step 2

    Run-in period

    During this period, participants continue their usual asthma medication to ensure stability before starting the trial treatment.

    Compliance with medication and study requirements is monitored through electronic assessments.

  3. Step 3

    Randomization and treatment

    Participants are randomly assigned to receive either the study medication, AZD4604, or a placebo.

    The medication is administered as an inhalation powder, taken twice daily for a duration of twelve weeks.

  4. Step 4

    Treatment monitoring

    Throughout the twelve-week treatment period, participants' lung function and asthma symptoms are regularly assessed.

    Key assessments include lung function tests and symptom questionnaires at weeks 4 and 12.

  5. Step 5

    End of treatment

    At the end of the treatment period, final assessments are conducted to evaluate the efficacy and safety of the medication.

    Participants' experiences and any changes in asthma symptoms are documented.

Who can join the trial?

14 criteria

  • Must be between 18 to 80 years old at the time of signing the consent form.
  • Both males and females can participate. Females should use birth control methods as per local rules. No restrictions for males or their female partners.
  • Must have a lung function test result called FEV1 (Forced Expiratory Volume in 1 second) between 40% and 90% of what is predicted for a healthy person.
  • FEV1 should not change by 20% or more between the first and third visits.
  • Must have an ACQ-6 score (Asthma Control Questionnaire) of 1.5 or higher.
  • Must take at least 80% of their usual asthma medication during the initial study period.
  • Must complete at least 80% of daily electronic health assessments during the initial study period and 14 days before the third visit.
  • Females of childbearing potential or on hormone replacement therapy must have a negative pregnancy test before starting the study medication.
  • Must have been treated with high-dose ICS (Inhaled Corticosteroids) and LABA (Long-Acting Beta-Agonists) at a stable dose for at least 3 months before the first visit.
  • Must have had at least one severe asthma attack in the year before the first visit.
  • Must be able to perform lung function tests according to specific guidelines.
  • Must have a documented history of asthma in the 10 years leading up to the first visit, with a clinical diagnosis at least 12 months before the first visit.
  • Must be able and willing to follow the study requirements, including reading, writing, understanding the language used in the study, and using electronic devices like a spirometer.
  • Must weigh at least 40 kg and have a body mass index (BMI) of less than 35 kg/m².

Who cannot join the trial?

10 criteria

  • Patients who have other serious health conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have had a recent asthma attack that required hospitalization.
  • Patients who are currently using other medications that might affect the study results.
  • Patients who have a history of not following medical advice or treatment plans.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medication or its ingredients.
  • Patients who have a history of drug or alcohol abuse.
  • Patients who have a condition called **COPD** (Chronic Obstructive Pulmonary Disease), which affects breathing.
  • Patients who have a history of cancer, unless it was a type that is not expected to come back.
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Investigated drugs

AZD4604 is an investigational medication being studied for its potential to help adults with moderate to severe asthma that is not well controlled with their current treatment. This medication is taken twice daily and is being evaluated for its effectiveness and safety over a period of twelve weeks. The goal of the study is to see if AZD4604 can improve asthma symptoms and overall lung function in patients who are already using medium to high doses of inhaled corticosteroids and long-acting beta-agonists.

What is already known about the treatment

AZD4604 – This medication is administered in the form of an inhaler, used twice daily. It is currently in Phase 2a of clinical trials, focusing on its efficacy and safety for treating moderate-to-severe asthma in adults who do not respond well to medium-high dose inhaled corticosteroids combined with long-acting beta-agonists. The main therapeutic indication is for asthma that remains uncontrolled despite standard treatments. AZD4604 works by targeting specific pathways in the respiratory system to reduce inflammation and improve breathing. It is classified as an investigational drug within the respiratory therapeutic area.

Investigated diseases

Asthma – Asthma is a chronic respiratory condition characterized by inflammation and narrowing of the airways, leading to difficulty in breathing. It often presents with symptoms such as wheezing, coughing, shortness of breath, and chest tightness. The severity of asthma can vary, with some individuals experiencing mild symptoms and others having more severe episodes. In moderate-to-severe cases, asthma may not be well-controlled even with the use of medium to high doses of inhaled corticosteroids and long-acting beta-agonists. This can result in frequent exacerbations, where symptoms worsen significantly and may require additional medical attention. The progression of asthma involves periods of symptom flare-ups and remissions, influenced by various triggers such as allergens, exercise, and respiratory infections.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-506000-50-00Protocol codeD8210C00003Estimated enrolment320 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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