Inadequately Controlled Asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: BFF MDI DFP 160
Product Code: PT009
Pharmaceutical Form: Pressurised inhalation, suspension
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Current Sponsor code: Budesonide
Other
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 12 to 80 years of age, male and female, BMI =65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1. 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). 2. 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. 3. Hospitalization for asthma within 8 weeks 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 (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. 5. Known history of drug or alcohol abuse within 12 months of Visit 1. 6. Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1. 7. 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 this protocol is prohibited for use during study duration. 8. Previous or current randomization into studies within the AEROSPHERE program including KALOS, LOGOS, VATHOS, LITHOS, or any glycopyrronium studies (PT001). 9. Use of a nebulizer or a home nebulizer for receiving asthma medications. 10. Do not meet the stable dosing period prior to Visit 1 or unable to abstain from protocol-defined prohibited medications during Screening and Treatment Periods. 11. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg, vector, lipid nanoparticle) 10 pack-years history, or former smokers who stopped smoking < 6 months prior to Visit 1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana). 15. Planned hospitalization during the study. 16. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members. 18. Judgment by the Investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements. 19. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI (superiority) on lung function in participants with inadequately controlled asthma;Secondary Objective: 1. To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI 320 µg (superiority) on lung function. 2. To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI 320 µg on symptoms and patient reported outcomes.;Primary end point(s): 1. Europe (EU): Change from baseline in morning pre-dose trough FEV1 over 24 Weeks.;Timepoint(s) of evaluation of this end point: Europe(EU) over 24 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. EU (Key secondary): To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI. - Change from baseline in FEV1 AUC0-3 over 24 Weeks. 2. To assess the effect of BFF MDI 320/9.6 µg relative to BD MDI and Symbicort TBH on lung function, symptoms, and PROs. - Change from baseline in the mean number of puffs of rescue medication use (puffs/day) over 24 Weeks. - Percentage of responders in ACQ-7 (= 0.5 decrease equals response) over 24 Weeks. - Percentage of responders in ACQ-5 (= 0.5 decrease equals response) over 24 Weeks. - Percentage of responders in the AQLQ(s)+12 (= 0.5 increase equals response) over 24 Weeks. - Percentage of responders in AQLQ(s)+12 (= 0.5 increase equals response) over 12 to 24 weeks. - Onset of action on Day 1: Absolute change in FEV1 at 5 minutes postdose on Day 1.;Timepoint(s) of evaluation of this end point: As listed for each endpoint. | — |
Countries
Canada, Germany, Italy, Japan, Spain, United States, Viet Nam
Contacts
Public ContactClinical Study Information Center
AstraZeneca AB
Outcome results
None listed