Ajax

Summary

AJAX is a new clinical study for people with asthma. We are looking at whether an experimental treatment called AZD4604 may improve asthma symptoms and help reduce the risk of flare-ups (also known as exacerbations).

AZD4604 is taken using an inhaler, similar to other asthma medicines.

You will continue to take your regular asthma medication throughout the study as well as your rescue therapy, should you have any attacks (exacerbations) of your condition during the trial. You will be assigned to add either AZD4604 or placebo to your regular medication. The “placebo” will be an inhaler that does not contain any study medicine.

Below is a summary of key eligibility criteria for this clinical trial. Additional criteria will apply. If you’re interested in taking part, please contact us using the contact details below for a full assessment.

Key points

Inclusion Criteria

  1. Male or female participants 18 to 80 years old.
  2. Treated with medium-high dose ICS in combination with LABA at a stable dose for at least 28 days prior to Visit 1.
  3. Documented history of ≥ 1 severe asthma exacerbation within 1 year prior to Visit 1.
  4. Documented evidence of asthma in the 10 years up to or including Visit 1.
  5. Body weight of ≥ 40 kg and body mass index of < 35 kg/m2.

Exclusion Criteria

  1. A severe asthma exacerbation within 8 weeks prior to randomisation.
  2. History of herpes zoster reactivation eg, shingles.
  3. Participants with a significant COVID-19 illness within 6 months of enrolment.
  4. Clinically important pulmonary disease other than asthma.
  5. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator.
  6. History of cancer.
  7. Treatment with steroids within 4 weeks (oral) or 8 weeks (intramuscular) before Visit 1.
  8. Concurrent enrolment in another interventional clinical study
  9. For female participants only – currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
  10. Current smokers or participants with smoking history ≥ 10 pack-years.
  11. Participants with a known long-term exposure to occupational asbestos, silica, radon, heavy metals, and polycyclic aromatic hydrocarbons.
  12. Positive family history of primary lung cancer in first degree relatives (mother, father, sisters, brothers and children).

Duration

AJAX will last up to 5 months and has 4 parts:

Screening (2 weeks): tests and assessments (including a physical examination, vital signs, blood and urine tests, tests to see how well your lungs are working, heart tests, questionnaires, and samples from inside your nose) at the study clinic to make sure you meet the study criteria for taking part.

Run-in (4 weeks): you will complete some tests and assessments at home, using a study smartphone. This will help the study team confirm whether AJAX is right for you.

Treatment (around 12 weeks): if the study is right for you, you will start getting either AZD4604 or placebo. You will be given 3 inhalers to use at home and will take 1 puff of each, twice a day.Follow-up (1 week): a final visit after you have finished the study treatment to check on your health and wellbeing.

Further Resources

https://www.astrazenecaclinicaltrials.com/study/D8210C00003

https://clinicaltrials.gov/study/NCT06020014?term=D8210C00003&viewType=Table&rank=1