A Study to Assess the Efficacy of Budesonide/Albuterol Metered-dose Inhaler (BDA MDI/PT027) on Exercise-induced Bronchoconstriction in Adults and Adolescents With Asthma
Condition: Exercise Induced Bronchospasm
MeSH terms: Bronchial Spasm; Asthma, Exercise-Induced
Intervention: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg; Placebo metered-dose inhaler
Intervention description: Budesonide/albuterol sulfate combination inhalation aerosol single dose; Placebo inhalation aerosol single dose
Intervention MeSH terms: Budesonide; Albuterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 12 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This is a multicenter, randomized, double-blind, single-dose, placebo-controlled, 2-period,
      crossover study to evaluate the efficacy and safety of budesonide/albuterol metered-dose
      inhaler (BDA MDI/PT027) as compared with a placebo metered-dose inhaler (placebo MDI) on
      exercise-induced bronchoconstriction (EIB) in adult and adolescent subjects with asthma.
      Subjects will receive each study treatment on separate visits and undergo a treadmill
      exercise challenge test for up to 10 minutes so that the effect of study treatment on
      exercise-induced bronchoconstriction can be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Female or male aged 12 to 70 years at the time of informed consent

          2. Documented history of asthma for at least 6 months prior to Visit 1

          3. 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/rapid-acting β 2-adrenoreceptor agonist (SABA) used as needed

               -  Low- to medium-dose maintenance therapy with inhaled corticosteroid (ICS) and
                  SABA used as needed

          4. Demonstrate acceptable MDI administration technique (use of a spacer device during the
             treatment phase is not permitted)

        Exclusion Criteria:

          1. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic
             bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or
             bronchopulmonary dysplasia), including regular or occasional use of oxygen

          2. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months
             before Visit 1

          3. History of life-threatening asthma, defined by past intubations for asthma, or
             intensive care unit admission for asthma within the prior 24 months

          4. 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

          5. Unable to tolerate the lung function testing performed after exercise challenge test
             without use of rescue medication

          6. 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)

          7. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1,
             regardless if resulting in accompanying asthma symptoms aggravation or not

          8. Upper respiratory infection involving antibiotic treatment not resolved within 7 days
             prior to Visit 1

          9. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab,
             dupilumab) or investigational biologic within 3 months before Visit 1, or any other
             prohibited medication

         10. Current treatment with any investigational product or within the last 30 days of Visit
             1.

         11. Historical or current evidence of a clinically significant disease

         12. Cancer not in complete remission for at least 5 years before Visit 1

         13. Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1

         14. History of psychiatric disease or intellectual deficiency

         15. Having a scheduled or planned hospitalization during the study

         16. Inability (and/or unwillingness) to abstain from protocol-defined prohibited
             medications during the study.

         17. 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.

         18. Significant abuse of alcohol or drugs