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Allergy & Asthma Network helped recruit patients for the MANDALA asthma study in 2021. The study results are now published. We are excited to share that the research could lead to a promising new asthma treatment.

People with moderate to severe asthma may soon have a new treatment option. A recent phase 3 study called MANDALA looked at if combining two specific asthma medications reduced asthma attacks.

In the study, medical researchers combined:

  • albuterol, a quick-relief medication that relaxes airway muscles and improves breathing
  • budesonide, an inhaled corticosteroid that decreases airway swelling and inflammation

People with moderate to severe asthma used the drug combination as-needed or when symptoms flared. Results of the study showed the drug combination reduced the risk of asthma attacks.

The MANDALA study was presented at the American Thoracic Society International Conference in May 2022. It could lead to the development of a new asthma medication.

What is the MANDALA study?

A growing number of treatment options are available to manage moderate to severe asthma. However, these treatments don’t always work well for everyone. Some, such as oral corticosteroids, come with potentially serious side effects.

Researchers wanted to find out if the albuterol-budesonide combination could help asthma patients. Albuterol can improve airflow but it does not treat ongoing inflammation. That’s where budesonide can help.

The MANDALA study examined this potential new asthma medication. It’s currently referred to as PT027. The Phase 3 clinical trial involved 3,132 adults, adolescents and children ages 4-11 with moderate to severe asthma. Participants also reported at least one asthma attack in the previous year. They hailed from 295 sites in the United States, Europe and South America.

Patients were randomly assigned to one of three treatment groups:

  • Group 1: given a combination of albuterol (180 mcg) and budesonide (160 mcg)
  • Group 2: given a combination of albuterol (180 mcg) and budesonide (80 mcg)
  • Group 3: a control group given albuterol (180 mcg)

The three groups were then evaluated over a 24-week treatment period.

What are the key takeaways of the MANDALA study?

Patients who were given the combination reduced their risk of asthma attacks compared to the control group.

  • Group 1 – albuterol (180 mcg) and budesonide (160 mcg):
    • reduced risk of asthma attack by 27%
    • reduced risk of asthma attack annually by 24%
    • reduced use of corticosteroid medication by 33%
  • Group 2 – albuterol (180 mcg) and budesonide (80 mcg):
    • Reduced risk of asthma attack by 17%

Bradley Chipps, MD, a board-certified allergist and pediatric pulmonologist, is co-author of the study. Dr. Chipps is past president of the American College of Allergy, Asthma & Immunology (ACAAI) and serves on Allergy & Asthma Network’s Editorial Advisory Board.

Dr. Chipps says the combination of as-needed albuterol and budesonide provided additional anti-inflammatory treatment compared to albuterol alone. It helped stop symptoms from progressing to an asthma attack.

The results bolster the growing body of evidence supporting the as-needed treatment approach for asthma. The study may also reduce prescriptions to oral corticosteroids, which have harmful side effects if used long term.

Research results were published in the New England Journal of Medicine. PT027 is a potential first-in-class inhaled, fixed-dose, quick-relief medication. It contains both albuterol and budesonide. PT027 is in development by AstraZeneca and Avillion.

Reviewed by:
Bradley Chipps, MD, FACAAI, is a board-certified allergist and pediatric pulmonologist with Capital Allergy and Respiratory Disease Center in Sacramento, California. He earned his medical degree from University of Texas Medical Branch in Galveston in 1972. He is Past President of the American College of Allergy, Asthma and Immunology (ACAAI).