MedTrace Logo

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

NCT06433921 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2025-10-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Salbutamol HFA-152a

A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.

DRUG

Salbutamol HFA-134a

A single 100, 200 or 400 μg dose, given as 1, 2 or 4 × 100 μg actuations (exvalve) at 20 second intervals.

DRUG

Placebo

A single placebo HFA-152a suspension or placebo HFA-134a suspension dose, given as at 20 second intervals.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2026-10-30
Completion
2026-11-06

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06433921 on ClinicalTrials.gov