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Beta-2 Agonist

Salbutamol Inhalers for Asthma

Phase 3
Recruiting
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Asthma for ≥ 6 months with documented history of asthma as defined by Global Initiative for Asthma (GINA)
Asthma that has remained stable with no severe exacerbations in the last 6 months
Must not have
Biologic/immunosuppressive therapies used for the treatment of respiratory diseases during the 6 months, or 5 half-lives-whichever is longer-prior to start of the study
History of life-threatening asthma or unstable asthma
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1) and up to 3 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial will check if two different types of salbutamol inhalers are safe and well-tolerated for people 12 years and older with asthma.

Who is the study for?
This trial is for people aged 12 and older with stable asthma, as defined by the Global Initiative for Asthma (GINA), who have not had a severe exacerbation in the last 6 months. Participants must have controlled asthma with an ACQ score <1.5 and be able to withhold short-acting bronchodilators for at least 6 hours before testing.
What is being tested?
The study compares safety and tolerability of salbutamol delivered via two different propellants in inhalers: HFA-152a versus HFA-134a. It's designed to see if there's any difference between these two types of metered dose inhalers over a three-month treatment period.
What are the potential side effects?
Potential side effects from using salbutamol may include tremors, headache, fast heart rate, muscle cramps, dry mouth or throat irritation. These are common when taking medications through an inhaler but can vary among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had asthma for at least 6 months, as per GINA guidelines.
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My asthma has been stable without severe attacks for 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I haven't used biologic or immunosuppressive therapies for respiratory issues in the last 6 months or 5 half-lives, whichever is longer.
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I have had severe or uncontrolled asthma in the past.
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I do not have significant lung diseases other than asthma.
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My asthma management changed due to a respiratory infection not resolved in 4 weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1) and up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1) and up to 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Change from baseline in Asthma Control Questionnaire (ACQ-6) score

Side effects data

From 2023 Phase 1 trial • 28 Patients • NCT05791565
11%
Headache
7%
Vessel puncture site bruise
4%
Palpitations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Salbutamol HFA-152a MDI
Salbutamol HFA-134a MDI

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Salbutamol Test ArmExperimental Treatment1 Intervention
Group II: Salbutamol Reference ArmActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Salbutamol HFA-152a
2023
Completed Phase 1
~30

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor
4,808 Previous Clinical Trials
8,380,966 Total Patients Enrolled
301 Trials studying Asthma
500,100 Patients Enrolled for Asthma
~165 spots leftby Apr 2025
Unbiased ResultsWe believe in providing patients with all the options.
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