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

Launched by GLAXOSMITHKLINE · May 23, 2024

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ClinConnect Summary

This clinical trial is investigating how effective a medication called salbutamol is for treating mild asthma when delivered through two different types of inhalers. The inhalers use different propellants—HFA-134a and HFA-152a—and the study aims to see which one works better for patients. Participants will be mild asthmatics aged between 18 and 65 who have been stable on their current asthma medications for at least 12 weeks. They should not have had severe asthma attacks in the last six months and must meet certain health criteria to ensure their safety during the study.

If you or someone you know is interested in participating, it’s important to know that this is a Phase 1 trial, which means it’s one of the first steps in testing the medication's effectiveness and safety. Participants will receive either type of inhaler and will be closely monitored throughout the study. This includes tests to measure their lung function and response to the medication. The goal is to help improve asthma treatment options by finding out which inhaler provides better relief for patients with mild asthma.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
• • 2. Participant must be 18 to 65 years of age inclusive, at the time of screening.
• • 3. ≥50 kg, at the time of screening.
• • 4. Documented history of asthma ≥ 6 months.
• 5. Receiving 1 of following asthma treatments, at a stable dose, for at least 12 weeks prior to the screening visit and is anticipated to remain stable for the duration of the study:
• • i. Short-acting beta-agonist (SABA) only. ii. Daily maintenance low-dose inhaled corticosteroids (ICS) (defined as 100-250 μg/day fluticasone propionate or equivalent plus or minus SABA which is anticipated to remain stable for the duration of the study.
• • iii. Daily maintenance low-dose ICS + Long-acting beta-2 agonist (LABA) therapy (low-dose ICS defined as 100-250 μg/day fluticasone propionate or equivalent as defined by GINA \[GINA, 2023\]) plus or minus SABA, which is anticipated to remain stable for the duration of the study.
• • 6. No severe asthma exacerbations within 6 months prior to screening and ≤1 severe exacerbation during the 12 months prior to screening.
• • 7. Pre-bronchodilator FEV1 ≥80% of predicted, at screening
• • 8. PC20 to methacholine of ≤8 mg/mL, at screening.
• • 9. A female participant is eligible to participate if she is not pregnant or breastfeeding, and Is a woman of woman of nonchildbearing potential (WONCBP) OR ii. Is a woman of child bearing potential (WOCBP) and using a contraceptive method that is highly effective.
• • 10. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
• • 11. Non-smokers who have not used any tobacco containing-products within 12 months prior to study start, and with a total pack year history of ≤10 pack years.
• Exclusion Criteria:
• • 1. Medical Conditions
• • 1. A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
• • 2. A history of respiratory diseases to include (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, cystic fibrosis, bronchiectasis, interstitial lung disease, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other respiratory abnormalities other than asthma.
• • 3. Asymptomatic gallstones.
• • 4. History or current evidence of hematologic, neurologic, psychiatric, or other diseases that, in the opinion of the investigator, would put the participant at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
• • 5. Recent eye surgery or any other condition in which raised intracranial pressure (caused by forceful exhalation) would be harmful.
• • 6. Current use of cholinesterase inhibitor medication e.g., to treat myasthenia gravis.
• • 2. Exposure to more than 4 new chemical entities within 12 months prior to the first dosing day or participation in a clinical study within 30 days of study start, or 5 half-lives of study drug if that is longer.
• • 3. Participants who are currently or in the last 15 days have worked nightshifts.
• • 4. Regular alcohol consumption within 6 months prior to the study defined as: an average weekly intake of \>21 units for males or \>14 units for females.
• • 5. A positive test result for drugs of abuse (including tetrahydrocannabinol) at screening or Day -1.
• • 6. Use of combustible tobacco products, and non-combustible nicotine delivery systems, inclusive of cigarettes, cigars, pipes, and materials used to "vape" within 12 months prior to the start of the study.