drugset / Trial / NCT06433921
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
RandomizedCrossoverTriple-blindOther
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.
Timeline
- Start
- 2024-08-14
- Primary completion
- 2027-02-26
- Completion
- 2027-02-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Salbutamol | Unknown | 100 ug | Inhaled |
| Subject | Salbutamol | Unknown | 200 ug | Inhaled |
| Subject | Salbutamol | Unknown | 400 ug | Inhaled |