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Study on the Effects of AZD4604 on Airway Inflammation in Adults with Asthma

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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, a condition that affects the airways in the lungs, making it difficult to breathe. The treatment being tested is called AZD4604, which is administered as an inhalation powder. The purpose of the study is to understand how AZD4604 affects the body, particularly in terms of airway inflammation and certain biological markers in adults with asthma.

Participants in the study will be randomly assigned to receive either AZD4604 or a placebo, which is a substance with no active medication. The study will last for four weeks, during which participants will use the inhalation powder daily. Researchers will monitor changes in the expression of specific genes in the airway cells, as well as other indicators of inflammation and cell types in the airways. This will help determine the safety and effectiveness of AZD4604 in treating asthma.

The study aims to provide valuable insights into how AZD4604 works in the body and its potential benefits for people with asthma. By comparing the effects of AZD4604 to those of the placebo, researchers hope to gather important data that could lead to improved treatments for asthma in the future.

The research process

The trial runs in 6 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, the participant will be informed about the trial's purpose and procedures. Consent will be obtained to ensure understanding and agreement to participate.

  2. Step 2

    Initial assessment

    Participants will undergo an initial assessment to confirm eligibility. This includes verifying age, weight, and asthma diagnosis, as well as ensuring compliance with asthma medication.

  3. Step 3

    Run-in period

    During the run-in period, participants will continue their usual asthma medication. Compliance with medication and daily assessments will be monitored to ensure at least 70% adherence.

  4. Step 4

    Randomization and treatment

    Participants will be randomly assigned to receive either the AZD4604 inhalation powder or a placebo. The treatment will be administered via inhalation for a duration of 4 weeks.

  5. Step 5

    Monitoring and assessments

    Throughout the treatment period, participants will undergo regular monitoring. This includes assessments of lung function and collection of samples to evaluate changes in gene expression and cell counts in the airways.

  6. Step 6

    End of treatment evaluation

    At the end of the 4-week treatment period, participants will have a final evaluation. This will include a review of changes in airway inflammation and biomarkers.

Who can join the trial?

19 criteria

  • Participants must be between 18 and 75 years old at the time of signing the consent form.
  • Participants should weigh at least 40 kg and have a body mass index (BMI) less than 35 kg/m². BMI is a measure of body fat based on height and weight.
  • Both males and females can participate. Females must follow local rules for birth control during the study. There are no birth control restrictions for males.
  • Females who cannot have children, either due to surgery or menopause, have specific criteria to meet. Menopause is when a woman stops having periods for 12 months or more.
  • Females who can have children and are sexually active must use a highly effective birth control method for at least 3 months before the study, during the study, and for 1 month after the study ends.
  • All females must have a negative pregnancy test at the start of the study.
  • Participants must be able to give written consent and agree to follow the study's rules and restrictions.
  • Participants must provide consent for optional genetic research if they choose to participate in that part of the study.
  • Participants must have at least 70% compliance with their usual asthma medication during the initial period of the study.
  • Participants must complete at least 70% of daily electronic health assessments during the 10 days before a specific study visit.
  • Females who can have children and those on hormone replacement therapy must have a negative urine pregnancy test before receiving the study medication.
  • Participants must have a doctor's diagnosis of asthma for at least 12 months before the study starts.
  • Participants must be on a stable dose of medium-to-high dose inhaled corticosteroids (ICS) with a long-acting beta-agonist (LABA) for at least 2 months before the study. Other asthma treatments at a stable dose are allowed, but not systemic corticosteroids.
  • Participants must have a history of at least one severe asthma attack in the year before the study or a specific score on an asthma control questionnaire. A severe asthma attack is a worsening of asthma that requires certain treatments or hospital visits.
  • Participants must have a specific lung function test result at the start of the study.
  • Participants must be able to perform lung function tests according to specific guidelines.
  • Participants must be able and willing to undergo a bronchoscopy, a procedure to look inside the airways.
  • Participants must have documented evidence of asthma in the past 5 years, shown by specific tests or measurements.
  • Participants must be able and willing to follow the study's requirements, including reading, writing, understanding the language of the study materials, and using electronic devices like a spirometer, which measures lung function.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to any of the ingredients in the study medication.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a significant medical condition that could interfere with the study, such as uncontrolled high blood pressure or heart disease.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of drug or alcohol abuse within the past year.
  • Patients who have had a major surgery within the past three months.
  • Patients who have a known infection that requires treatment with antibiotics.
  • Patients who have a history of cancer within the past five years, except for certain types of skin cancer.
  • Patients who have a condition that affects their immune system, such as HIV.
  • Patients who are unable to follow the study procedures or attend the required visits.
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Investigated drugs

AZD4604 is a medication being studied for its potential effects on airway inflammation and biomarkers in adults with asthma. The trial aims to understand how this medication influences gene expression in airway epithelial cells, which are important for maintaining healthy lung function.

What is already known about the treatment

AZD4604 – This medication is administered as an inhalation, targeting the respiratory system directly. It is currently in Phase II clinical trials, focusing on its effects on airway inflammation and biomarkers in adults with asthma. The main therapeutic indication for AZD4604 is asthma, a condition characterized by chronic inflammation of the airways. At the molecular level, AZD4604 is designed to influence gene expression in airway epithelial cells, potentially reducing inflammation and improving respiratory function. It falls under the pharmacological classification of anti-inflammatory agents, specifically aimed at respiratory conditions.

Investigated diseases

Asthma – Asthma is a chronic condition that affects the airways in the lungs, causing them to become inflamed and narrow. This inflammation leads to symptoms such as wheezing, shortness of breath, chest tightness, and coughing. The severity and frequency of these symptoms can vary from person to person. Asthma can be triggered by various factors, including allergens, exercise, cold air, and respiratory infections. Over time, repeated asthma attacks can lead to changes in the airways, making them more sensitive and reactive. Managing asthma involves avoiding triggers and monitoring symptoms to prevent flare-ups.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-510291-32-00Protocol codeD8210C00005Estimated enrolment33 patientsSponsorAstraZeneca AB

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