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A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma

A Randomized, Non-inferiority, Double-blind, Controlled, Single-dose, 2-way Cross-over Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Metered Dose Inhalers in Adults Aged 18-45 With Mild Asthma

NCT06702462•GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The purpose of the study is to assess the propellants,1 - Difluoroethane \[HFA-152a\] (Test) and 1,1,1,2-Tetrafluoroethane \[HFA-134a\] (Reference) for their potential to cause the airways to tighten when delivered through pressurized metered dose inhalers (pMDI). The rationale for this study is to develop a low carbon footprint alternative propellant, HFA-152a, which will have a lower impact on global warming.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants are eligible to be included in the study if all the following criteria apply:
•Male or female; females may be of childbearing potential, of nonchildbearing potential, or postmenopausal.
•Participant must be 18 to 45 years of age inclusive, at the time of screening.
•Confirmed diagnosis of asthma: documented, established diagnosis of asthma for at least 6 months.
•Receiving 1 of the 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:
•* As needed short-acting beta-agonists (SABA) only
•* As needed SABA plus low-dose Inhaled corticosteroids (ICS) (defined as 100-250 µg/day fluticasone propionate or equivalent taken whenever SABA is taken).
•* Daily maintenance low-dose ICS, plus as needed SABA or ICS-SABA single inhaler combination therapy
•* Low dose combination single inhaler ICS-formoterol or single inhaler ICS-SABA as needed for symptom relief (and if needed, before exercise)
•* Leukotriene receptor antagonist (LTRAs) in combination with any of the above therapies
+11 more criteria

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•A history of life-threatening asthma or asthma that is unstable in the opinion of the investigator.
•Asthma treatment requiring use of biologic agents (e.g. mepolizumab or dupilumab), chronic systemic corticosteroids, or oral controller agents other than LTRAs.
•Respiratory disorders other than asthma; 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 and other respiratory abnormalities other than asthma 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 and/or requires additional therapy during the study. This includes history of lung cancer and previous thoracic surgery such as lung resection.
•Asthma Exacerbation: Any severe asthma exacerbation within 6 months prior to screening. (Severe asthma exacerbation defined as a deterioration of asthma requiring the use of systemic corticosteroids (tablets, suspension, or injection) for at least 3 days, or a single depo injection or an in-patient hospitalization or early discontinuation (ED) visit due to asthma that required systemic corticosteroids).
•Biologic/immunosuppressive therapies that can be used for the treatment of respiratory diseases during the 6 months, or 5 half-lives whichever is longer-prior to start of the study.
•Participants undergoing de-sensitization therapy.
•Administration of systemic, oral, or depot corticosteroids for asthma treatment within 12 weeks of Visit 1. Intranasal corticosteroids are permitted if at a stable dose for at least 3 months prior to screening.
•Stable doses (3 months or longer) of the following are permitted:
•* Intranasal corticosteroids
+1 more criteria

Locations (3)

GSK Investigational Site

Marlton, New Jersey, United States

GSK Investigational Site

Huntersville, North Carolina, United States

GSK Investigational Site

San Antonio, Texas, United States

Key Dates

Start Date

March 11, 2025

Primary Completion Date

June 4, 2025

Completion Date

June 4, 2025

Last Updated

August 26, 2025

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

HFA-152A propellant

DRUG

HFA-134A propellant

DRUG

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RECRUITINGPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 26, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Assess the Potential for Airway Sensitivity Reactions With Propellants HFA-152a (Test) and HFA-134a (Reference) Administered Via Pressurized Inhalers in Adults With Mild Asthma

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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