Home › Trials › NCT06502366

Investigating a new asthma treatment using a different propellant

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

Phase 3 Interventional AstraZeneca · NCT06502366

This study is testing a new way to deliver an asthma treatment using a different propellant to see if it works as well as the current method for people with asthma.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment398 (estimated)
Ages18 Years and up
SexAll
SponsorAstraZeneca Industry-sponsored
Drugs / interventionsprednisone
Locations136 sites (Mobile, Alabama and 135 other locations)
Trial IDNCT06502366 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the pharmacodynamic equivalence of an approved asthma combination therapy, BDA, when delivered with a new propellant (HFO) compared to the currently approved propellant (HFA). Participants with asthma will undergo a screening and placebo run-in period followed by three treatment periods, each lasting four weeks. The study will monitor lung function and safety through in-clinic visits and follow-up calls. The total duration for each participant will be approximately 14 to 15 weeks.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a physician-diagnosed asthma condition for at least 12 months.

Not a fit: Patients with severe asthma or those requiring high-dose inhaled maintenance therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective asthma treatment option with potentially improved delivery mechanisms.

How similar studies have performed: Other studies have shown promise in evaluating new propellants for asthma treatments, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / 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.

Where this trial is running

Mobile, Alabama and 135 other locations

+86 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Asthma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.