NOW ENROLLING: A CLINICAL RESEARCH STUDY FOR PEOPLE WITH ASTHMA

The BATURA Study is a clinical research study exploring a potential new treatment for adolescents and adults with asthma.

You could take part in the BATURA Study if you:

• Are 12 years of age and older*
• Have had a clinical diagnosis of asthma, by a healthcare professional
• Are actively using SABA (Short-acting Beta-agonist) inhalers to control or reduce your asthma symptoms, alone or in combination of regular treatment with either low inhaled corticosteroid (ICS) or leukotriene inhibitor (such as montelukast).

*Parental consent is required for those under 18 years of age.

There are more criteria to meet, which will be discussed with you.

About the BATURA Study

The BATURA Study is being conducted to understand better the potential anti-inflammatory effects of an investigational study drug called PT027 on reducing the risk of severe asthma attacks. Participants will be randomized into two groups

Group 1 will receive the study experimental drug, PT027

Group 2 will receive another investigational asthma drug, called PT007

Both drugs contain albuterol which has been used for treating asthma for over 40 years. Researchers want to find out if the investigational drug, PT027 which also contains the anti-inflammatory drug budesonide that has been used in asthma for over 30 years, is safe and effective at reducing the symptoms and inflammation that may trigger an asthma attack. Neither you nor your doctor/study team will know which study drug you will receive.

Who will be joining the study?

Approximately 1,900 individuals from the USA are expected to participate in the BATURA Study. Study involvement may last from 12 – 52 weeks, dependent on the overall number of asthma attacks occurring from all participants in the study. All communication with the study team will be virtual. There are no scheduled in-person clinic visits required.

What will be involved?

Eligible participants will:
• Receive the investigational drugs, directly at home
• Use the Hailie® sensor on the inhaler device to track inhaler usage
• Report any asthma attacks via a smartphone app
• Attend 8 virtual visits with the study team

For further information about the BATURA Study, please contact:

Cynthia
281-984-4358
Email: cynthia@linqresearchllc.com

Joining this study is completely voluntary – it is your choice to take part or not. If you do take part, you can change your mind and leave the study at any time for any reason – you will still be cared for by your usual doctor and your medical care will not be affected. If you decide not to take part the medical care you receive will not be affected.