Suspended

Budesonide and Albuterol Inhaler Comparison for Asthma

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Study Aim

This study compares the effectiveness of two inhalers, Budesonide and Albuterol, in improving lung function in asthma patients, focusing on changes in breathing within 60 minutes after use.

What is being tested

BDA MDI HFO 160/180 μg

+ BDA MDI HFA 160/180 μg

+ Placebo MDI HFA

Drug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

Over 18 Years
+22 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorAstraZeneca
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 22, 2024

Actual date on which the first participant was enrolled.

This study is exploring whether a new type of inhaler propellant, called HFO, works as well as the current propellant, HFA, in delivering a combination asthma medication known as BDA. This medication is used to help manage asthma symptoms. The study's aim is to ensure that people with asthma can receive their medication effectively with the new propellant, which might have environmental or practical benefits over the current one. Understanding this will help ensure that asthma treatments remain effective while potentially improving safety or environmental impact. Participants in the study will be involved for about 14 to 15 weeks. Initially, there is a 2-week period to screen participants and prepare them with a placebo. Then, they will undergo three different treatment phases, each lasting 4 weeks. During these phases, the participants will use inhalers with either the current or new propellant. Regular clinic visits will occur every 2 to 4 weeks to monitor treatment effects and ensure safety. A follow-up call will happen about 5 days after the last treatment to check on the participants' well-being. The study is designed to closely monitor the effectiveness of the inhaler propellants in delivering asthma medication safely.

Official TitleA 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
NCT06502366
Principal SponsorAstraZeneca
Last updated: February 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

422 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

10 inclusion criteria required to participate
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 body mass index < 40 kg/m2.

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.

Show More Criteria

12 exclusion criteria prevent from participating
Hospitalization for psychiatric disorder or attempted suicide within 1 year of Visit 1.

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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFO

Group II

Active Comparator
160/180 µg Budesonide/albuterol pressurized inhalation suspension, HFA

Group III

Placebo
Placebo pressurized inhalation suspension, HFA

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 128 locations

Suspended

Research Site

Mobile, United StatesOpen Research Site in Google Maps
Suspended

Research Site

Sheffield, United States
Suspended

Research Site

Phoenix, United States
Suspended

Research Site

Little Rock, United States
Suspended128 Study Centers