Clinical trial NCT04234464: 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
Official title: A Randomized, Double-blind, Single-dose, 2-Period, Crossover Study to Assess the Efficacy of PT027 Compared With Placebo on Exercise-Induced Bronchoconstriction in Adult and Adolescent Subjects With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Exercise Induced Bronchospasm
Lead sponsor: Bond Avillion 2 Development LP
Sponsor class: INDUSTRY
First posted: 2020-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
timeFrame: Up to 60 minutes post exercise challenge
Secondary outcomes:
measure: Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10%
timeFrame: Up to 60 minutes post exercise challenge
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: North Dartmouth
country: United States
facility: Research Site
state: Massachusetts
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Skillman
country: United States
facility: Research Site
state: New Jersey
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Burke
country: United States
facility: Research Site
state: Virginia
Study officials:
affiliation: Avillion LLP
name: Frank Albers, MD, PhD
role: STUDY_DIRECTOR
References:
citation: LaForce C, Chipps BE, Albers FC, Reilly L, Johnsson E, Andrews H, Cappelletti C, Maes A, Papi A. Albuterol/budesonide for the treatment of exercise-induced bronchoconstriction in patients with asthma: The TYREE study. Ann Allergy Asthma Immunol. 2022 Feb;128(2):169-177. doi: 10.1016/j.anai.2021.10.020. Epub 2021 Oct 24.