Budesonide and Albuterol Inhaler Comparison for Asthma
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.
BDA MDI HFO 160/180 μg
+ BDA MDI HFA 160/180 μg
+ Placebo MDI HFA
Asthma+6
+ Bronchial Diseases
+ Hypersensitivity
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.422 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
Active ComparatorGroup III
PlaceboStudy 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
Research Site
Sheffield, United StatesResearch Site
Phoenix, United StatesResearch Site
Little Rock, United States