A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI… (NCT06433921) | Clinical Trial Compass
RecruitingPhase 1
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
United Kingdom84 participantsStarted 2024-08-14
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion 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.
Exclusion criteria
✕. 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, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.
✕. 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 analyses if the disease exacerbates during the study.
What they're measuring
1
Provocative concentration of methacholine causing at least a 20% fall in FEV1 (PC20)
✕. 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.