BridgeMD
Compares treatment options for Asthma
Official title A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
ClinicalTrials.gov ID: NCT06433921
What this study is testing
What is Salbutamol HFA-152a?
Salbutamol HFA-152a is an investigational medicine, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objectives of the study are: Part 1: to characterize the potency and variability of dose response on efficacy (Provocative concentration of methacholine causing at least a 20% fall in forced expiratory volume (FEV1) [PC20]) of salbutamol administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma. Part 2: to compare the comparative dose response on efficacy (PC20) of salbutamol when administered via MDI with salbutamol HFA-134a or salbutamol HFA-152a in participants with mild asthma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Participant must be 18 to 65 years of age inclusive, at the time of screening.
- ≥50 kg, at the time of screening.
- Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening. 4\. Documented history of asthma ≥ 6 months. 5. Receiving 1 of...
You likely can't join if
- Medical Conditions
- A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic...
- Asymptomatic gallstones.
- History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the...
- Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.
See the full eligibility criteria
- Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
- Participant must be 18 to 65 years of age inclusive, at the time of screening.
- ≥50 kg, at the time of screening.
- Body mass index (BMI) with 19.0-35.0 kg/m2 inclusive, at the time of screening. 4\. Documented history of asthma ≥ 6 months. 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior...
- Medical Conditions
- A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
- A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease...
- Asymptomatic gallstones.
- History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study...
- Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.
- Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.
- Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.
- Participants who are currently or in the last 15 days have worked nightshifts.
- Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \>21 units for males or \>14 units for females.
- A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.
- Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Manchester, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Manchester, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.