A Study to Investigate the Effect on Lung Function of BDA Formulated With a New Propellant (HFO) Compared With an Approved Asthma Treatment (BDA With HFA Propellant) in Participants With Asthma
- Conditions
- Asthma
- Registration Number
- NCT06502366
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 398
Inclusion Criteria:<br><br> - Participant must be = 18 years of age at the time of signing the ICF.<br><br> - Participants who have physician diagnosed asthma as defined by GINA for at least 12<br> months prior to Visit 1.<br><br> - Eligible participants are on either a) no daily inhaled maintenance therapy or b)<br> daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA.<br> Participants who are on low-dose ICS maintenance therapy are required to be stable<br> on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose<br> ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6<br> months prior to Visit 1.<br><br> - Participants with a pre-bronchodilator FEV1 of = 60% and < 90% predicted normal at<br> Visit 1 or Visit 1a.<br><br> - Participants with a pre-dose FEV1 of = 60% and < 90% predicted normal at Visit 2<br> that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.<br><br> - Participants who demonstrate bronchodilator responsiveness defined as a > 12% and ><br> 200 mL increase in FEV1 relative to baseline following administration of study<br> provided SABA at Visit 1 or Visit 1a.<br><br> - Participants able to demonstrate acceptable spirometry performance as defined by the<br> acceptability and repeatability criteria in the ATS/ERS Standardization of<br> Spirometry 2019 update<br><br> - Participants who are willing and, in the opinion of the investigator, able to adjust<br> current asthma therapy, as required by the protocol.<br><br> - Participants with a body mass index < 40 kg/m2.<br><br> - Females must not be of childbearing potential or, if of childbearing potential,<br> using a form of birth control<br><br>Exclusion Criteria:<br><br> - Confirmed or suspected diagnosis of COPD or clinically significant non-asthma<br> airway/lung disease.<br><br> - Systemic corticosteroid use (eg, prednisone for 3 or more days or a single<br> depo-injectable dose of corticosteroids) for any respiratory, immune, or<br> allergy-attributed disease within 6 months prior to Visit 1.<br><br> - An upper respiratory infection requiring antibiotic treatment that is not resolved<br> within 7 days prior to Visit 1.<br><br> - A lower respiratory infection in the 4 weeks prior to Visit 1.<br><br> - Life-threatening asthma defined as any history of significant asthma episode(s)<br> requiring admission to an intensive care unit, positive pressure ventilation<br> associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related<br> syncopal episode(s) within 5 years of Visit 1.<br><br> - Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg,<br> prednisone for 3 or more days or a single depo-injectable dose of corticosteroids)<br> for asthma within 6 months prior to Visit 1.<br><br> - A severe asthma exacerbation during the run-in period<br><br> - An ePRO device alert during the run-in period with investigator-confirmed worsening<br> asthma symptoms<br><br> - Historical or current evidence of a clinically significant disease including, but<br> not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm,<br> clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal,<br> hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus,<br> uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or<br> gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux<br> disease) disorders. Significant is defined as any disease that, in the opinion of<br> the investigator, would put the safety of the participant at risk through study<br> participation or that could affect the efficacy or safety analyses if the<br> disease/condition exacerbated during the study.<br><br> - Unresectable cancer that has not been in complete remission for at least 5 years<br> prior to Visit 1<br><br> - Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit<br> 1.<br><br> - Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at<br> any time during the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29;Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
- Secondary Outcome Measures
Name Time Method Change from baseline in morning pre-dose trough FEV1;Change from baseline in morning pre-dose trough FEV1