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Study on the Safety and Effectiveness of AZD8630 for Adults with Uncontrolled Asthma at Risk of Exacerbations

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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 adults with uncontrolled asthma. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it difficult to breathe. The study will test a medication called AZD8630, which is an inhalation powder designed to help manage asthma symptoms. Participants in the trial will receive either AZD8630 or a placebo, which is a substance with no active medication, to compare the effectiveness of the treatment.

The purpose of the study is to evaluate how well AZD8630 works in preventing asthma flare-ups, known as exacerbations, in people whose asthma is not well controlled despite using other medications. The trial will last for 12 weeks, during which participants will take the medication once daily. The study will also assess the safety of AZD8630 and its impact on lung function, asthma symptoms, and overall quality of life.

Participants will use a device called the Saphira to inhale the medication. This device is designed to deliver the dry powder form of AZD8630 directly to the lungs. The study aims to provide valuable information on the potential benefits of AZD8630 for people with asthma who are at risk of experiencing severe symptoms. The trial will help determine if AZD8630 can be a safe and effective option for managing 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, you will be randomly assigned to receive either the study medication, AZD8630, or a placebo. This process is double-blind, meaning neither you nor the study team will know which one you are receiving.

  2. Step 2

    Medication administration

    You will take the assigned medication as an inhalation powder once daily. The duration of this treatment is 12 weeks.

  3. Step 3

    Regular assessments

    Throughout the study, you will have regular assessments to monitor your asthma symptoms and overall health. These assessments will include lung function tests and questionnaires about your asthma control and quality of life.

  4. Step 4

    Home monitoring

    You will be required to perform daily assessments at home, including measuring your peak expiratory flow (PEF) in the morning and evening. This helps track your lung function over time.

  5. Step 5

    Clinic visits

    You will have scheduled visits to the clinic at specific intervals during the study. These visits will include more detailed lung function tests and other evaluations to ensure your safety and the effectiveness of the treatment.

  6. Step 6

    End of study

    At the end of the 12-week period, you will have a final assessment to evaluate the overall impact of the treatment on your asthma. This will include a review of your symptoms, lung function, and any side effects experienced during the study.

Who can join the trial?

14 criteria

  • Patient must be between 18 and 80 years old at the time of signing the consent form.
  • Patient must have a lung function test result called FEV1 (Forced Expiratory Volume in 1 second) that is at least 40% of the expected value at both the first and second visits.
  • The increase in FEV1 between the first and second visits should be less than 400 ml.
  • Patient must have a history of asthma worsening (called exacerbations) in the last 12 months, with specific criteria for severity and frequency.
  • Patient must have at least 80% compliance with their usual asthma medication during the initial period of the study.
  • Patient must complete daily assessments, including electronic diaries and peak flow measurements, at least 80% of the time during the 14 days before the second visit.
  • If the patient is on high-dose inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) and is eligible for injectable biologic therapy, they must be unable or unwilling to receive it, or it must be deemed inappropriate by the investigator.
  • Patient's BMI (Body Mass Index) must be between 18 and 37 kg/m2 at the time of signing the consent form and at the second visit.
  • Female patients of childbearing potential must have negative pregnancy tests at the first and second visits and must not be breastfeeding. They must also agree to use effective birth control methods during the study and for 20 days after the last dose of the study medication.
  • Male patients and their female partners of childbearing potential must agree to use effective birth control methods and refrain from donating sperm or fathering a child during the study and for 20 days after the last dose of the study medication.
  • Patient must be able to give signed informed consent.
  • Patient must have a documented diagnosis of asthma for at least 12 months, with specific criteria for confirmation.
  • Patient must be treated with medium- or high-dose ICS in combination with LABA, with a stable dose for at least 30 days before the first visit. Additional asthma medications at a stable dose are allowed.
  • Patient must have uncontrolled asthma, demonstrated by an ACQ-6 (Asthma Control Questionnaire) score of 1.5 or higher at both the first and second visits.

Who cannot join the trial?

8 criteria

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who are currently participating in another clinical trial.
  • Patients who have a significant medical condition other than asthma that could interfere with the study.
  • 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 been diagnosed with a serious mental health condition that is not well controlled.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

AZD8630 is a medication being tested to help people with asthma. Asthma is a condition where the airways in the lungs become narrow and make it hard to breathe. This medication is inhaled, which means you breathe it in through your mouth so it can go directly to your lungs. The goal of using AZD8630 is to see if it can help prevent asthma attacks, which are times when asthma symptoms suddenly get worse. The study is looking at how well AZD8630 works and if it is safe for people to use over a period of 12 weeks.

What is already known about the treatment

AZD8630 – AZD8630 is an investigational medication administered through inhalation, designed for adults with asthma that remains uncontrolled despite the use of medium to high doses of inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA). Currently, AZD8630 is being studied in clinical trials to determine its effectiveness and safety in reducing asthma exacerbations. The main therapeutic indication for AZD8630 is to help manage asthma in patients who are at risk of severe asthma attacks. At the molecular level, AZD8630 works by targeting specific pathways in the lungs to reduce inflammation and improve breathing. It is classified pharmacologically as an anti-inflammatory agent for respiratory conditions.

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 disease progresses with episodes known as asthma attacks, where symptoms become more severe and can be triggered by allergens, exercise, cold air, or stress. Over time, if not managed, asthma can lead to persistent airway inflammation and remodeling, which may cause a decline in lung function. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more frequent and severe exacerbations. Asthma is often managed by avoiding triggers and using medications to control inflammation and open the airways.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514228-18-00Protocol codeD6830C00003Estimated enrolment515 patientsSponsorAstraZeneca AB

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