a study to assess the efficacy and safety of budesonide/albuterol metered-dose inhaler (bda mdi/pt027) in adults and children 4 years of age or older with asthma

Conditions: Asthma

Summary: this is a randomized, double-blind, multicenter, parallel-group, variable-length study to compare 2 doses of bda mdi (pt027) with as mdi (pt007) on the time to first severe asthma exacerbation in adult, adolescent, and pediatric subjects with moderate to severe asthma.


Eligibility criteria:
inclusion criteria: 1. female or male aged ≥4 years at the time of informed consent 2. physician diagnosis of asthma documented for at least 1 year 3. receiving 1 of the following scheduled asthma maintenance therapies for 3 months with stable dosing for at least the last 4 weeks before visit 1: * medium-to-high-dose inhaled corticosteroid (ics) * medium-to-high-dose ics and 1 additional maintenance therapy from the following: leukotriene receptor antagonists (ltra), long-acting muscarinic antagonists (lama), or theophylline * low-to-high-dose ics in combination with long-acting β2-adrenoreceptor agonist (laba) with or without one additional maintenance therapy from the following: ltra, lama, or theophylline 4. prebronchodilator forced expiratory volume in 1 second (fev1) of ≥40 to \<90% predicted normal value for adults and adolescents, and ≥60 to \<100% predicted normal value for subjects aged 4 to 11 years after withholding specified medications including short/rapid-acting β2-adrenoreceptor agonist (saba) 5. demonstrate reversibility at visit 1, with an increase in fev1 ≥12% (and ≥200 ml for subjects aged ≥18 years) relative to baseline after administration of sponsor provided ventolin via central spirometry. one re-test for reversibility testing is allowed within the screening period in advance of visit 2 6. demonstrate acceptable spirometry performance (i.e., meet american thoracic society/european respiratory society acceptability/repeatability criteria) 7. a documented history of at least 1 severe asthma exacerbation within 12 months before visit 1 8. able to perform acceptable and reproducible peak expiratory flow (pef) measurements as assessed by the investigator exclusion criteria: 1. chronic obstructive pulmonary disease or other significant lung disease (e.g., chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia) 2. oral corticosteroid/scs use (any dose and any indication) within 6 weeks before visit 1 3. chronic use of oral corticosteroids (ocs, ≥3 weeks use in 3 months prior to visit 1) 4. having received any marketed (e.g., omalizumab, mepolizumab, reslizumab, benralizumab) or investigational biologic within 3 months or any other prohibited medication 5. current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months before visit 1 (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana) 6. life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma related syncopal episode(s) within 5 years of visit 1 7. historical or current evidence of a clinically significant disease 8. cancer not in complete remission for at least 5 years 9. hospitalization for psychiatric disorder or attempted suicide within 1 year of visit 1 10. history of psychiatric disease, intellectual deficiency, poor motivation, or other conditions if their magnitude is limiting informed consent validity 11. significant abuse of alcohol or drugs