A Study to Investigate the Effects of PT027 (Budesonide/Albuterol Sulfate) Metered-dose Inhaler Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult Patients With Asthma

Korábbi kezelés

• Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1.
• History of life-threatening asthma, defined by past intubations for asthma, or intensive care unit admission for asthma within the prior 24 months.
• Receiving regular maintenance treatment with prohibited anti-inflammatory or long-acting bronchodilator asthma medication (inhaled, nebulized, oral, or systemic) within 1 month prior to Visit 1.
• Unable to tolerate the lung function testing performed after exercise challenge test without use of rescue medication.
• 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).
• Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1, regardless if resulting in accompanying asthma symptoms aggravation or not.
• Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1.
• Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months before Visit 1, or any other prohibited medication.
• Inability (and/or unwillingness) to abstain from protocol-defined prohibited medications during the study.
• Significant abuse of alcohol or drugs.

Más betegség

• Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, bronchopulmonary dysplasia), including regular or occasional use of oxygen.
• Historical or current evidence of a clinically significant disease.
• History of psychiatric disease or intellectual deficiency.

Egyéb

• Having a scheduled or planned hospitalization during the study.
• Use of any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and/or the unwillingness to stop during the study duration.

• Female or male aged 18 to 70 years at the time of informed consent.
• Documented history of asthma for at least 6 months prior to Visit 1
• Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1 (no other asthma therapies are permitted during the study):
  • Short-acting β 2-adrenoreceptor agonist (SABA) used as needed;
  • Low- to medium-dose maintenance therapy with inhaled corticosteroid (ICS) and SABA used as needed.
• Demonstrate acceptable MDI administration technique (use of a spacer device during the treatment phase is not permitted)