Severe and inadequately controlled asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 12 to 80 years of age, male and female, BMI and/or = 1 year prior to V1. 3. 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. 4. ACQ-7 total score =1.5 at Visits 1, 3, and 5 (pre-randomization). 5. 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: and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL. • Participants 12 to =65 years) yes F.1.3.1 Number of subjects for this age range 239
Exclusion criteria
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 halflives 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 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 3 months of V1. 6. Use of LAMA, either alone or as part of an inhaled combination therapy, in the 12 weeks prior to Visit 1. 7. Use of oral beta2-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 a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main Objective of D5982C00008 1. To assess the effect of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler (BGF MDI) relative to Budesonide and Formoterol Fumarate (BFF) MDI or Symbicort Pressurized MDI on lung function in participants with inadequately controlled asthma. Main Objective of Pooled Studies D5982C00007 and D5982C00008 1. To assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on asthma exacerbations in participants with inadequately controlled asthma.;Secondary Objective: Secondary Objectives of D5982C00008 1. To assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on lung function in participants with inadequately controlled asthma. 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 Objectives of Pooled Studies D5982C00007 and D5982C00008 1. To assess the effect of BGF MDI relative to BFF MDI or Symbicort pMDI on asthma exacerbations in participants with inadequately controlled asthma.;Primary end point(s): Primary end point(s) of D5982C00008. 1. Europe (EU): Change from baseline in morning pre-dose trough FEV1 over 24 Weeks. Primary end point(s) of Pooled Studies D5982C00007 and D5982C00008. 1. Rate of severe asthma exacerbations.;Timepoint(s) of evaluation of this end point: D5982C00008 Baseline to week 24. Pooled Studies D5982C00007 and D5982C00008 Treatment period (between week 1 to week 52). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end point(s) of D5982C00008. 1. Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1. XML File Identifier: oaOrG4qToNkjVhdG1qiIvmQ8Y8o= Page 27/49 2. Change from baseline in FEV1 AUC0-3 over 24 weeks. 3. Percentage of responders in ACQ-7 (=0.5 decrease equals response) over 24 weeks. 4. Percentage of responders in ACQ-5 (=0.5 decrease equals response) over 24 weeks. 5. Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s) +12) (=0.5 increase equals response) over 24 weeks. 6. Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (=4.0 unit decrease equals response) at Week 24. 7. Rate of severe asthma exacerbations over the Treatment Period. Secondary end point(s) of Pooled Studies D5982C00007 and D5982C00008. 1. Time to first severe asthma exacerbation. 2. Rate of moderate/severe asthma exacerbations. 3. Time to first moderate/severe asthma exacerbation. 4. Rate of severe asthma exacerbations for participants with percent predicted FEV1 = 55% at baseline. 5. Rate of severe asthma exacerbations for participants with = 1 severe exacerbation in the 12 months prior to Visit 1;Timepoint(s) of evaluation of this end point: D5982C00008 Baseline to week 24. Pooled Studies D5982C00007 and D5982C00008 Treatment period (between week 1 to week 52). | — |
Countries
Brazil, China, Czechia, Czech Republic, Germany, Greece, Israel, Mexico, Portugal, Russian Federation, Slovakia, South Africa, Turkey, United Kingdom, United States
Contacts
Public ContactClinical Study Information Centrer
AstraZeneca AB
Outcome results
None listed