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Beta-2 Agonist

Salbutamol Test Arm for Asthma

Phase 3
Waitlist Available
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights

Study 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.

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
4,751 Previous Clinical Trials
8,067,052 Total Patients Enrolled
294 Trials studying Asthma
415,007 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for participants in this research study?

"As per clinicaltrials.gov, the current trial is not in active recruitment. Originally posted on April 19, 2024 and last updated on February 8, 2024, this study has completed patient enrollment. Nonetheless, there are currently 311 other trials actively seeking participants."

Answered by AI

Are there multiple locations in the city where this research is being conducted?

"At the moment, this research is ongoing at 80 different facilities. These include centers in Alexandroupolis, Roma, and Katowice among various other places. Opting for the nearest site can reduce travel obligations for participants."

Answered by AI

What are the risks associated with the Salbutamol Test Arm for individuals participating in this study?

"The safety assessment for the Salbutamol Test Arm in this Phase 3 trial has been rated as a level 3 by our team at Power. This score is based on existing efficacy data and extensive safety data from multiple evaluations."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
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 12 Years of Age and Older With Asthma
2024. "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 12 Years of Age and Older With Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06261957.
~280 spots leftby Apr 2025
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