Do you suffer from inadequately controlled Asthma?
This clinical research study is looking at the safety and effectiveness of a medication for people with persistent asthma. Asthma is a condition in which your airways narrow and swell and may produce extra mucus. This can make breathing difficult and trigger coughing, a whistling sound (wheezing) when you breathe out, and shortness of breath.
Would you like to contribute to medical research?
As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your asthma to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with asthma, and whether it will be made widely available to all patients with asthma. Study volunteers are an important part of moving medical care forward.
You may qualify to participate in this study if you:
- Are 12 to 80 years of age, male or female, BMI <40 kg/m2; females of childbearing potential should be using highly effective birth control.
- Have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1, according to GINA guidelines [GINA 2021]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to < 18 years of age) to ensure consistent evaluation and follow-up of treatment in those participants.
- Have been regularly using a stable daily ICS or an ICS/LABA regimen (including a stable ICS dose), with allowed ICS doses, for at least 8 weeks prior to Visit 1.
- Have asthma stability during run-in based on Investigator discretion
- Are willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
- Demonstrate acceptable MDI administration technique.
- Have eDiary compliance ≥ 70% during screening, defined as completing the daily eDiary and answering “Yes” to taking 2 puffs of run-in BD MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization
You may not qualify to participate if you:
- Have life-threatening asthma as defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s).
- Have any respiratory infection or asthma exacerbation treated with systemic corticosteroids and/or additional ICS treatment in the 8 weeks prior to Visit 1 and throughout the Screening Period.
- Experience hospitalization for asthma within 8 weeks of Visit 1.
- Have historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary (eg, active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD). Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
- Have a known history of drug or alcohol abuse within 12 months of Visit 1.
- Have unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. Note: Squamous cell and basal cell carcinomas of the skin are not exclusionary.
- Are in another clinical study with an Investigational Product administered in the last 30 days or 5 half-lives, whichever is longer. Any other Investigational Product that is not identified in this protocol is prohibited for use during study duration.
- Have previous or current randomization in any budesonide and formoterol fumarate or budesonide, glycopyrronium, and formoterol fumarate studies (PT009 or PT010).
- Use a nebulizer or a home nebulizer for receiving asthma medications. Note: Acute use of a nebulizer for an asthma exacerbation during hospitalization is allowed as long as there is no occurrence within 8 weeks of Visit 1.
- Do not meet the stable dosing period prior to Visit 1 or are unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods.
- Have received a COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector, lipid nanoparticle) ≤7 days prior to Visit 1 (from last vaccination or booster dose).
- Have a known hypersensitivity to beta2-agonists, corticosteroids, or any component of the MDI.
- Have any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, vital signs, or electrocardiogram (ECG), which in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study.
- Are a current smoker, former smoker with > 10 pack-years history, or a former smoker who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).
- Plan hospitalization during the study.
- For women only – currently pregnant (confirmed with positive highly sensitive urine pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether you are eligible to participate in the study or not.