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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 (TYREE)

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ClinicalTrials.gov Identifier: NCT04234464
Recruitment Status : Recruiting
First Posted : January 21, 2020
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Bond Avillion 2 Development LP

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.

Condition or disease Intervention/treatment Phase
Exercise Induced Bronchospasm Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg Combination Product: Placebo metered-dose inhaler Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : January 15, 2020
Estimated Primary Completion Date : August 12, 2020
Estimated Study Completion Date : November 15, 2020


Arm Intervention/treatment
Experimental: BDA MDI (PT027) 160/180 μg
BDA MDI (PT027)
Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg
Budesonide/albuterol sulfate combination inhalation aerosol single dose
Other Name: BDA MDI (PT027) 160/180 μg

Placebo Comparator: Placebo MDI Combination Product: Placebo metered-dose inhaler
Placebo inhalation aerosol single dose




Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 60 minutes post exercise challenge ]
    Lung function will be measured by spirometry. Spirometry assessments will be completed at 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. The percentage fall in FEV1 will be calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.


Secondary Outcome Measures :
  1. Percentage of subjects with a maximum percentage fall in FEV1 post-exercise challenge of <10% [ Time Frame: Up to 60 minutes post exercise challenge ]
    The percentage fall in FEV1 will be calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall <10% will be determined.



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04234464


Contacts
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Contact: Jenny Kern 984-459-5314 jenny.kern@syneoshealth.com

Locations
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United States, North Carolina
Research Site Recruiting
Raleigh, North Carolina, United States, 27607
Sponsors and Collaborators
Bond Avillion 2 Development LP

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Responsible Party: Bond Avillion 2 Development LP
ClinicalTrials.gov Identifier: NCT04234464    
Other Study ID Numbers: AV005
First Posted: January 21, 2020    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Bronchial Spasm
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Asthma
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Albuterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action