A study to investigate the effect on lung function of BDA formulated with a new propellant (HFO) compared with an approved asthma treatment (BDA with HFA propellant) in participants with asthma

Study identifier:D6933C00002

ClinicalTrials.gov identifier:NCT06502366

EudraCT identifier:N/A

CTIS identifier:N/A

Recruiting

Official Title

A Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of Budesonide and Albuterol (BDA) Delivered by MDI HFO Compared with BDA Delivered by MDI HFA in Participants with Asthma

Medical condition

asthma

Phase

Phase 3

Healthy volunteers

Study drug

BDA MDI HFO 160/180 μg, BDA MDI HFA 160/180 μg, Placebo MDI HFA

Sex

All

Estimated Enrollment

398

Study type

Interventional

Age

18 Years - n/a

Date

Study Start Date: 22 Jul 2024

Estimated Primary Completion Date: 24 Feb 2026

Estimated Study Completion Date: 24 Feb 2026

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Jul 2024 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

-Participant must be ≥ 18 years of age at the time of signing the ICF.
-Participants who have physician diagnosed asthma as defined by GINA for at least 12 months prior to Visit 1.
-Eligible participants are on either a) no daily inhaled maintenance therapy or b) daily inhaled maintenance therapy with low-dose ICS or low-dose ICS-LABA. Participants who are on low-dose ICS maintenance therapy are required to be stable on therapy for a minimum of 3 months prior to Visit 1; participants using low-dose ICSLABA maintenance regimens are required to be stable on therapy for a minimum of 6 months prior to Visit 1.
-Participants with a pre-bronchodilator FEV1 of ≥ 60% and < 90% predicted normal at Visit 1 or Visit 1a.
-Participants with a pre-dose FEV1 of ≥ 60% and < 90% predicted normal at Visit 2 that is within ± 20% of their Visit 1 pre-bronchodilator FEV1.
-Participants who demonstrate bronchodilator responsiveness defined as a > 12% and > 200 mL increase in FEV1 relative to baseline following administration of study provided SABA at Visit 1 or Visit 1a.
-Participants able to demonstrate acceptable spirometry performance as defined by the acceptability and repeatability criteria in the ATS/ERS Standardization of Spirometry 2019 update
-Participants who are willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
-Participants with a body mass index < 40 kg/m2.
-Females must not be of childbearing potential or, if of childbearing potential, using a form of birth control

Exclusion Criteria

-Confirmed or suspected diagnosis of COPD or clinically significant non-asthma airway/lung disease.
-Systemic corticosteroid use (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for any respiratory, immune, or allergy-attributed disease within 6 months prior to Visit 1.
-An upper respiratory infection requiring antibiotic treatment that is not resolved within 7 days prior to Visit 1.
-A lower respiratory infection in the 4 weeks prior to Visit 1.
-Life-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, positive pressure ventilation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within 5 years of Visit 1.
-Hospitalization due to asthma within 12 months or systemic corticosteroid usage (eg, prednisone for 3 or more days or a single depo-injectable dose of corticosteroids) for asthma within 6 months prior to Visit 1.
-A severe asthma exacerbation during the run-in period
-An ePRO device alert during the run-in period with investigator-confirmed worsening asthma symptoms
-Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, Cushing’s syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease) disorders. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or that could affect the efficacy or safety analyses if the disease/condition exacerbated during the study.
-Unresectable cancer that has not been in complete remission for at least 5 years prior to Visit 1
-Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1.
-Known history of drug or alcohol abuse within 12 months of Visit 1 or known abuse at any time during the study.

Sort by status

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Arms	Assigned Interventions
Active Comparator: BDA MDI HFO 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO	Drug: BDA MDI HFO 160/180 μg Budesonide/albuterol pressurized inhalation suspension, HFO
Active Comparator: BDA MDI HFA 160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA	Drug: BDA MDI HFA 160/180 μg Budesonide/albuterol pressurized inhalation suspension, HFA
Placebo Comparator: Placebo MDI HFA Placebo pressurized inhalation suspension, HFA	Drug: Placebo MDI HFA Placebo pressurized inhalation suspension, HFA

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]