Clinical trial NCT06502366: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2024-07-16
Enrollment: 398
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a Randomized, Placebo-controlled, Double-blind, Multicenter, 12-Week, 3-Way, Partial-replicate Crossover Pharmacodynamic Study to Assess the Equivalence of BDA MDI HFO Compared with BDA MDI HFA in Participants with Asthma.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

Detailed description: The purpose of this study is to assess the PD equivalence of the approved asthma combination therapy, BDA, delivered using the proposed replacement propellant HFO compared with BDA delivered using the currently approved propellant HFA in participants with asthma.

The study duration for each participant will be approximately 14 to 15 weeks and will consist of:

1. A screening and placebo run-in period of approximately 2 weeks prior to the first dose of study intervention
2. 3 treatment periods of 4 weeks each
3. A final safety follow-up visit via telephone contact approximately 5 days after the final dose of study intervention

Participants will attend in-clinic visits 2 weeks apart during the screening/run-in period (Visits 1 and 2) and then every 4 weeks during the treatment period (Visits 3, 4, and 5).

Eligibility 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.

Primary outcomes:
measure: Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
timeFrame: Change from baseline at Day 29
measure: Change from baseline in peak FEV1 in 0-60 minutes after dosing at Day 29
timeFrame: Change from baseline at Day 29
Secondary outcomes:
measure: Change from baseline in morning pre-dose trough FEV1
timeFrame: Change from baseline at Day 29
measure: Change from baseline in morning pre-dose trough FEV1
timeFrame: Change from baseline at Day 29
Other outcomes:
Locations:
city: Mobile
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facility: Research Site
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city: Sheffield
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state: Alabama
city: Phoenix
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state: Arizona
city: Little Rock
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state: Arkansas
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city: Sacramento
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city: Westminster
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city: Wheat Ridge
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city: Tallahassee
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city: Flint
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city: Raleigh
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city: Baotou
country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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country: China
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city: Hohhot
country: China
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city: Huizhou
country: China
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city: Jinan
country: China
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city: Jinhua
country: China
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city: Lanzhou
country: China
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city: Linhai
country: China
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city: Nanchang
country: China
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city: Pingxiang
country: China
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city: Qingdao
country: China
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city: Shanghai
country: China
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city: Shanghai
country: China
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city: Shanghai
country: China
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city: Shenyang
country: China
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city: Shenzhen
country: China
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city: Shijiazhuang
country: China
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country: China
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country: China
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city: Wenzhou
country: China
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country: China
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country: China
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country: China
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country: China
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city: Yangzhou
country: China
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country: China
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city: Zhengzhou
country: China
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city: Alor Setar
country: Malaysia
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city: Ampang
country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Malaysia
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country: Mexico
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country: Mexico
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city: Culiacan
country: Mexico
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city: Durango
country: Mexico
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city: Guadalajara
country: Mexico
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city: Guadalajara
country: Mexico
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city: Mazatlán
country: Mexico
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city: Mexico City
country: Mexico
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city: Monterrey
country: Mexico
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city: Monterrey
country: Mexico
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city: Mérida
country: Mexico
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city: San Juan del Rio
country: Mexico
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city: Tijuana
country: Mexico
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city: Veracruz
country: Mexico
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city: Zapopan
country: Mexico
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city: Bangkoknoi
country: Thailand
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city: Khon Kaen
country: Thailand
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city: Mueang
country: Thailand
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city: Ratchathewi
country: Thailand
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city: Ratchathewi
country: Thailand
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city: Abu Dhabi
country: United Arab Emirates
facility: Research Site
city: Ashton-under-Lyne
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
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city: Newcastle-Upon-Tyne
country: United Kingdom
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city: Hai Phong
country: Vietnam
facility: Research Site
city: Hanoi
country: Vietnam
facility: Research Site
city: Ho Chi Minh City
country: Vietnam
facility: Research Site
city: Ho Chi Minh
country: Vietnam
facility: Research Site
Study officials:
References: