Asthma Respiratory Disease
Conditions
Interventions
Subjects will be randomized in a 1:1:1:1 ratio to either BGF MDI
(320/57.6/9.6*g / day), BGF MDI (640/28.8/19.2*g / day), BFF MDI (640/19.2*g /
day) or Symbicort pMDI (320/18*g / day).
Sponsors
Astra Zeneca
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: (1.) Female or male subjects between 12-80 years inclusive, at the time of signing the ICF. (2.) Participants who have a documented history of physician-diagnosed asthma *1 year prior to Visit 1, according to GINA guidelines [GINA 2020]. Healthcare records for 1 year prior to Visit 1 must be provided for adolescent participants (12 to
Exclusion criteria
Exclusion criteria: (1.) 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). (2.) Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of Visit 1. (3.) Hospitalization for asthma within 2 months of Visit 1. (4.) Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary. (5.) 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. (6.) Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the Investigator, is clinically significant. (7.) Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. (8.) Oral and IV corticosteroid use (any dose) within 4 weeks of Visit 1. (9.) Depot corticosteroid use for any reason within 12 months of Visit 1. (10.) Use of LAMA as maintenance treatment, either alone or as part of an inhaled combination therapy, within 12 months prior to Visit 1. (11.) Use of oral beta2-agonist within 3 months of Visit 1. (12.) Any marketed (e.g., omalizumab, mepolizumab, benralizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives of Visit 1 (13.) Regular use of a nebulizer or a home nebulizer for receiving asthma medications. (14.) Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives. (15.) Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI. (16.) Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary objective is to assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on lung function in participants with inadequately controlled asthma, using the primary endpoint of change from baseline in morning pre-dose trough FEV1 over 24 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives are (1.) to assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on lung function in participants with inadequately controlled asthma and (2.) to assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on lung function, PROs, and symptoms in participants with inadequately controlled asthma. Secondary endpoints are (1.) Change from baseline in FEV1 AUC0-3 over 24 Weeks, (2.) Percentage of responders in ACQ-7 (*0.5 decrease equals response) at Week 24, over 24 Weeks or over 12 to 24 Weeks, (3.) Percentage of responders in ACQ-5 (*0.5 decrease equals response) at Week 24, over 24 Weeks or over 12 to 24 Weeks, (4.) Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ +12) (*0.5 increase equals response) at Week 24, over 24 Weeks or over 12 to 24 Weeks, (5.) Percentage of responders in the St. George*s Respiratory Questionnaire (SGRQ) (*4.0 unit decrease equals response) at Week 24, (6.) Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1 and (7.) Rate of severe asthma exacerbations over the Treatment Period | — |
Countries
Netherlands
Outcome results
None listed