Walgreens and AstraZeneca are seeking participants for a clinical study.

Are you 18 years of age or older with a diagnosis of asthma?

Consider joining the D6933C00002 clinical study, investigating a new propellant to help asthma treatments become more environmentally friendly.

Study Overview

Why is the D6933C00002 clinical study important?

Asthma is commonly treated with inhalers that contain medicines which help to reduce inflammation and swelling in the airways. To deliver these medicines into the lungs, these inhalers use a special type of medical gas known as a propellant. A common approved propellant is called HFA.

HFA propellant is known to contribute to global warming and many countries will soon have laws which stop it from being used in inhalers.

This means that more environmentally friendly propellants are needed to make sure asthma treatment can continue to be available globally.

That’s why a new propellant called HFO that is more environmentally friendly than HFA is being investigated.

The inhalers in this study will contain a treatment called budesonide and albuterol (BDA). BDA is already an approved treatment for asthma. The study will assess the effect on lung function (how well the lungs work in helping a person breathe) of BDA with HFO propellant as compared to BDA with HFA propellant.

Eligibility Criteria

This study is looking to enroll participants who:

  • Are 18 years of age or older

  • Have a confirmed diagnosis of asthma

  • Have improved lung function (how well the lungs work in helping a person breathe) using albuterol or salbutamol

There will be other study requirements that the study team will discuss with you.

Taking part in this study involves:

  • Learning about the details of the study and giving your consent to take part

  • Participation for approximately 3.5 months, including 3 treatment periods of 4 weeks each

  • Attending a total of 5 study visits and 1 phone call

Before you begin the study intervention, you will undergo a series of tests and procedures over approximately 2 weeks in what is called screening and placebo run-in period.

If you meet the screening eligibility criteria and choose to join the study, you will be randomly assigned (by chance) to 1 of 3 cohorts (Cohort A1, Cohort A2 and Cohort B) using test study intervention (BDA Metered-dose Inhaler (MDI) HFO), reference study intervention (BDA Metered-dose Inhaler (MDI) HFA), and placebo (placebo Metered-dose Inhaler (MDI) HFA is only in Cohort B).

The placebo looks like the study treatments containing BDA and is given in the same way, but it does not contain any active medicine. Placebos help us find out whether a medicine is working.

If you take part in this study the chance/likelihood that one of the three treatment periods will contain placebo (Cohort B), is approximately 30%.

Participants in Cohorts A1 and A2 will be randomly assigned to 1 of 3 treatment sequences, with each containing test and reference study interventions. Each participant will receive both test and reference study interventions but in a different order.

Participants in Cohort B will be randomly assigned to 1 of 6 treatment sequences, with each containing test, reference and placebo. Each participant will receive test, reference, and placebo study interventions but in a different order.

This study is double-blind, meaning neither you nor your study team will know which treatments you are taking, or what sequence they will be given in. This helps to keep the study fair and unbiased.

Frequently Asked Questions

  • Clinical research is the process of developing medicines or therapies to possibly prevent, treat, or help with diseases. Before a medicine can become available, it must be tested in a series of clinical studies to understand if it is safe and effective. With the help of clinical study participants, researchers can find out if and how potential new medicines work.

  • Participants will be in the study for approximately 3.5 months including a screening period that lasts around 2 weeks, a treatment period that lasts about 12 weeks, and a follow-up period that lasts about 5 days.

  • You may need to make some small changes to your diet and lifestyle while you are taking part in the study. This is to make sure that the study team can accurately measure your health and well-being, and how well the study treatments are working for you.

    Adjustments for the whole study
    Continue to avoid:

    • Smoking, including all forms of tobacco, marijuana, and e-cigarettes (or vaping)

    Adjustments around clinic visits
    Avoid:

    • Eating or drinking coffee, tea, cola drinks and chocolate 6 hours before, and for the whole time you are at your study clinic visit

    • Drinking alcohol 24 hours before spirometry tests

    • Use of rescue SABA for at least 6 hours before spirometry tests

    Your study team will advise you when to expect clinic visits and spirometry tests so you can plan to make any adjustments.

  • If you are taking the placebo, or the HFO propellant isn’t as effective at delivering BDA into your lungs as the HFA propellant, there is a chance your asthma symptoms could get worse. If you do notice any changes, you can use the rescue SABA inhaler you are provided with, which will be albuterol or salbutamol depending on which country you live in.

    Please be reassured that your study doctor will monitor you closely while you are taking treatment to identify any changes in your health and well-being quickly.

  • Yes. Taking part in a clinical study is always your choice. You can change your mind or stop taking part at any time, for any reason. Stopping the study will not affect the quality of care that you receive. If you would like to stop, please let your study doctor know as soon as you can. They will be able to discuss your options and next steps with you.