Trials / Completed
CompletedNCT06261957
A Study to Assess and Compare Safety and Tolerability of 3 Months Treatment With Salbutamol Administered Via MDI Containing Propellant HFA-152a or HFA-134a in Participants ≥ 18 Years of Age With Asthma
A Randomized, Double-blind, Parallel Group, Multi-center Study to Evaluate the Long-term Safety of Salbutamol Rescue Medication When Administered Via Metered Dose Inhalers Containing the Propellant HFA-152a or Reference HFA-134a
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 477 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to assess and compare the safety and tolerability of salbutamol administered via metered dose inhaler (MDI) containing propellant 1,1-difluoroethane (HFA-152a) or 1,1,1,2-tetrafluoroethane (HFA-134a) in participants aged \>=18 years with asthma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Salbutamol HFA-134a | 100 microgram (μg) (ex-valve) at 30-second intervals per actuation |
| DRUG | Salbutamol HFA-152a | 100 μg (ex-valve) at 30-second intervals per actuation |
Timeline
- Start date
- 2024-05-31
- Primary completion
- 2025-09-02
- Completion
- 2025-09-02
- First posted
- 2024-02-15
- Last updated
- 2026-02-27
Locations
101 sites across 13 countries: United States, Argentina, Australia, Canada, France, Greece, Italy, Panama, Philippines, Poland, Spain, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06261957. Inclusion in this directory is not an endorsement.