PT010 Inhaler for Asthma
(KALOS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of a new inhaler that combines budesonide, glycopyrronium, and formoterol for individuals with severe asthma not well-managed by standard treatments. The trial will compare this inhaler to existing ones to determine if it provides better asthma symptom control. It seeks participants who have had asthma for at least a year and frequently experience asthma attacks despite regular inhaler use. As a Phase 3 trial, this study is the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking advancements in asthma treatment.
Do I have to stop taking my current medications for the trial?
The trial requires that you adjust your current asthma therapy as needed, and you must not use certain medications like oral beta2-agonists, LAMA, or systemic corticosteroids close to the start of the study. It's best to discuss your specific medications with the study team to see if any changes are needed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the budesonide/glycopyrronium/formoterol inhaler is generally safe for people with severe asthma. Studies have found it to be as safe as other inhalers used to prevent asthma attacks. In one study, participants using the inhaler reported feeling better over 12 weeks, suggesting it could be a good choice for many.
Although the inhaler is still under testing for asthma, it has approval for other conditions, supporting its safety profile. However, like any medication, some individuals might experience side effects. Discuss any concerns with a doctor before joining a trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the PT010 inhaler for asthma because it combines three active ingredients: budesonide, glycopyrronium, and formoterol fumarate, offering a comprehensive approach to managing asthma symptoms. Unlike typical treatments such as Symbicort®, which only combines budesonide and formoterol, PT010 includes glycopyrronium, an anticholinergic agent that can help further open the airways and improve breathing. This unique combination may enhance symptom control and reduce asthma flare-ups more effectively than current options. By targeting multiple pathways in asthma management, PT010 has the potential to provide improved, long-lasting relief for patients.
What evidence suggests that this trial's treatments could be effective for severe asthma?
Research has shown that the budesonide/glycopyrronium/formoterol (BGF) inhaler, which participants in this trial may receive, could help people with severe asthma. This combination, known as triple therapy, has already improved breathing in other lung conditions like COPD, where airflow is blocked. In previous studies, patients using BGF inhalers breathed easier and experienced fewer symptoms over 12 weeks. Another study found that a similar BGF inhaler reduced health risks, such as the chance of dying, in people with lung problems. These results suggest the BGF inhaler might benefit those with severe asthma when regular treatments aren't enough.13567
Who Is on the Research Team?
Andrew Menzies-Gow, MD
Principal Investigator
Royal Brompton Hospital, United Kingdom
Are You a Good Fit for This Trial?
This trial is for adults and adolescents aged 12-80 with severe asthma that isn't well-controlled by their current treatment. They must have a BMI under 40, not be pregnant or breastfeeding, and use effective birth control if applicable. Participants should have been on a stable dose of inhaled corticosteroids and long-acting beta agonists for at least four weeks.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) or comparator treatments
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Budesonide/Glycopyrronium/Formoterol Inhaler
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology