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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 up to 3 months
Awards & highlights

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.Check my eligibility
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.See study design
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 ~up to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Adverse Events (AEs)
Secondary outcome measures
Absolute Values of Minimum serum potassium (milliequivalents per litre (mEq/L)
Absolute value of haematology parameter: Mean Corpuscle Volume (MCV) (Femtoliters)
Absolute value of haematology parameter: Mean Corpuscle haemoglobin (MCH) (Picograms)
+32 more

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
4,772 Previous Clinical Trials
8,106,491 Total Patients Enrolled
298 Trials studying Asthma
448,089 Patients Enrolled for Asthma
~275 spots leftby Apr 2025