Adolescents and adults at least 12 to 80 years of age with a history of physician-diagnosed asthma for 1 year or more, may qualify to participate in a study that will evaluate an investigational inhaler treatment for asthma. This inhaler contains a combination of three currently prescribed medications for asthma. The purpose of this study is to see whether this investigational inhaler treatment provides improved asthma control over other commonly prescribed asthma inhaler treatments.
Individuals must have regularly used a stable daily ICS/LABA (Inhaled Corticosteroid/Long-Acting β2-Agonist) regimen, for at least 4 weeks prior to screening. For adults 18+, a documented history of at least one asthma exacerbation requiring use of systemic corticosteroids (oral or IV) and any combination thereof for at least 3 consecutive days AND an associated physician visit, hospitalization, or ER visit due to asthma (within 3 days of the corticosteroid use) in the 12 months prior to screening, is also required.
Asthmatics with a medical history of any clinically significant disease that involves the heart, liver, kidneys, blood, nervous system, endocrine system, gastrointestinal tract, or lungs (such as active tuberculosis, bronchiectasis, pulmonary eosinophilic syndromes, and COPD) may not qualify. Current smokers, former smokers with a greater than 10 pack-years history, or former smokers who stopped smoking less than 6 months prior to screening (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana) need not apply.
Participants will receive an investigational inhaler treatment with three medications, OR an investigational inhaler treatment with two medications, OR an approved inhaler treatment. Study medication and study-related care will be provided at no cost. Reimbursement for study-related expenses will also be provided.
The following information is from ClinicalTrials.gov
Last Update Posted: March 26, 2023
This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care
Condition or Disease:
Intervention/Treatment:Drug: BGF MDI 320/28.8/9.6 μg
Ages Eligible for Study:
12 Years and 80 Years (Child)
Sexes Eligible for Study:
12 to 80 years of age, male and female, BMI <40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
Participants > and/or = 18 years of age: < 80%
Participants 12 to <18 years of age: < 90%
FEV1 post-albuterol at V2 or V3 (if repeat needed).
Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
Participants 12 to <18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3. Note: Reversibility testing is still required at Visit 2 and/or Visit 3, even if the patient has documented historical reversibility reported in the 12 months prior to Visit 1. Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol. Demonstrate acceptable MDI/pMDI administration technique. Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation). eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization). No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization. Exclusion Criteria: 1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1. 2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate. 2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration. 3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking <6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 4. Current evidence of Chronic Obstructive Pulmonary Disease (COPD). 5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1. 5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study. 5c. Depot corticosteroid use for any reason within 12 months of V1. 6. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1. 7. Use of oral b2-agonist within 3 months of V1. 8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration. 9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1. 10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s). 11. Hospitalization for asthma within 2 months of Visit 1. 12. Known history of drug or alcohol abuse within 12 months of Visit 1. 13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications. 14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration. 15. Participation in another clinical study with an Investigational Product. 16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI. 17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator. Please refer to the study protocol for the complete inclusion and exclusion criteria list.
Terms and Conditions – ClinicalTrials.gov
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