Recruiting

Phase 3

HFA-152a vs. HFA-134aA Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)

Sponsor:

GlaxoSmithKline

Code:

NCT07645248

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HFA-152a

HFA-134a

Study Details

Brief summary:

This study aims to generate additional safety data on the propellant component of the reformulated product by comparing metered dose inhaler (MDIs) containing HFA-152a (test) with HFA-134a (reference).

Conditions

Asthma

Study ID

NCT07645248

Start date

Sep 1, 2026

Status verified date

Nov, 2026

Completion date

Dec 28, 2026

Anticipated

Primary completion date

Dec 28, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Participant must be aged greater than equal to (>=)18 years at the time of signing the informed consent.
Participants with asthma for >= 6 months, defined as:

Documented history of asthma, as defined by Global Initiative for Asthma (GINA)
Receiving one of following asthma treatments for at least 12 weeks prior to the screening visit and which is anticipated to remain stable for the duration of the study:
Short-Acting beta2-Adrenoreceptor Agonists (SABA) as needed (prn) only
Inhaled corticosteroid (ICS)/SABA prn only
SABA prn plus ICS prn
SABA prn plus ICS maintenance
ICS/SABA prn plus ICS maintenance
SABA prn plus ICS/ Long-acting beta agonist (LABA) maintenance
ICS/SABA prn plus ICS/LABA maintenance
SABA prn plus ICS/ Long-acting muscarinic antagonist (LAMA)/LABA maintenance (open or closed triple therapy)
ICS/Formoterol combination therapy as reliever therapy
ICS/Formoterol combination therapy as maintenance therapy plus ICS/Formoterol combination as reliever therapy.
Leukotriene receptor antagonist (LTRA) as add-on any of the above is permitted
Xanthines as add-on to any of the above permitted
Biological therapies indicated for the treatment of asthma as add-on to any of the above are permitted (for example, but not limited to, mepolizumab, dupilumab, tezepelumab).
Participants with severity of disease:
Baseline pre-bronchodilator Forced expiratory volume in 1 second (FEV1) >=50 percent (%) of predicted at screening.
Asthma Control Status
Asthma Control Questionnaire (ACQ)-6 score less than (<) 1.5 at screening (and randomization).
Asthma that has remained stable with no severe exacerbations within the last 3 months.
Participants who are current non-smokers, who have not used any inhaled tobacco or vaping products within 12 months of the start of the study, and with a total pack year history of less than equal to (<=)10 pack. The use of inhaled marijuana, even with a valid prescription, is prohibited within 12 months prior to study start.
Participants who demonstrate ability to use pressurized MDI device in a satisfactory and repeatable manner, as judged visually by the investigator or designee.
Male and female participants are eligible.

A female participant is eligible to participate if they are not pregnant or breastfeeding, and one of the following conditions applies:

Is a Participant of nonchildbearing potential (PONCBP) or
Is a Participant of childbearing potential (POCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, 30 days prior to and during the study intervention period and for at least 24 hours after the last dose of study intervention. - A POCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours before the first dose of study intervention in each Treatment Period.

Adults capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed consent form (ICF).

Exclusion Criteria:

Participants with a history of life-threatening asthma.
Participants with other significant pulmonary diseases, including (but not limited to): pneumothorax, pulmonary fibrotic disease, bronchopulmonary dysplasia, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, tuberculosis, or other significant respiratory abnormalities other than asthma.
Respiratory Infection: Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening.
Participants with severe asthma exacerbation: Defined as any asthma exacerbation requiring >=3 days systemic corticosteroids or that resulted in overnight hospitalization or Emergency Department visit requiring additional treatment for asthma within the 3 months prior to screening.
Participants with Other concurrent Diseases/Abnormalities: A participant has any clinically significant, uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the participant at risk through study participation or would confound the interpretation of the study results.
Participants with current use of cholinesterase inhibitor medication (e.g. for myasthenia gravis).
Participants with any other prescription or over the counter medication which would significantly affect the course of asthma, or that could interact with sympathomimetic amines.
Participants with Drug or Excipient Allergy: Known or suspected sensitivity to the constituents of salbutamol MDI (e.g. HFA-134a, Oleic acid etc.).
Participants with exposure to more than four 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.
Participants with a known or suspected history of alcohol or drug abuse.
Any planned or anticipated changes in asthma medications during the study period.
Any planned environmental changes (e.g. employment changes, travel) which, in the Investigator's opinion, could lead to e.g. increased allergen exposure.
12-Lead ECG abnormality: Significant abnormality in the 12-lead ECG performed at screening.
Alanine transaminase (ALT) >2 times Upper limit of normal (ULN).
Total bilirubin >1.5 times ULN; For participants with Gilbert's syndrome can be included with total bilirubin >1.5 times ULN if direct bilirubin is <=1.5 times ULN.
Participants with Cirrhosis or current unstable liver or biliary disease.
Participants with QTc >480 milliseconds (msec).

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Participants receiving HFA-152a followed by HFA-134a

Participants will receive HFA-152a MDI in treatment period 1 followed by HFA-134a MDI in treatment period 2. There will be a washout period between the treatment periods.

experimental: Participants receiving HFA-134a followed by HFA-152a

Participants will receive HFA-134a MDI in treatment period 1 followed by HFA-152a MDI in treatment period 2. There will be a washout period between the treatment periods.

Interventions

HFA-152a

HFA-152a will be administered.

HFA-134a

HFA-134a will be administered.

Primary outcome measure

Number of participants with adverse events (AEs) [ Time Frame: Up to 8 weeks ]

Central Contacts and Locations

Central contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

Locations

GSK Investigational Site

Recruiting

Aventura, Florida, United States, 33180

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Jaime Landman

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33155

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Eduardo Martinez

GSK Investigational Site

Recruiting

Miami, Florida, United States, 33173-3484

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Ileana Rodicio

GSK Investigational Site

Recruiting

Naples, Florida, United States, 34102

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Lisette Delgado Sanchez

GSK Investigational Site

Recruiting

Owensboro, Kentucky, United States, 42301

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Lee Clore

GSK Investigational Site

Recruiting

Columbia, Missouri, United States, 65203

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mark Vandewalker

GSK Investigational Site

Recruiting

Henderson, Nevada, United States, 89052-5015

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Vikas Sayal

GSK Investigational Site

Recruiting

Medford, Oregon, United States, 97504

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Sarah Smiley

GSK Investigational Site

Recruiting

Spartanburg, South Carolina, United States, 29303-4225

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Farhan Siddiqui

GSK Investigational Site

Recruiting

Spartanburg, South Carolina, United States, 29303

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Charles Fogarty

GSK Investigational Site

Recruiting

Cypress, Texas, United States, 77429

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Dileep Puppala

GSK Investigational Site

Recruiting

Tomball, Texas, United States, 77375

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Mustafa Naeem

GSK Investigational Site

Recruiting

Ajax, Ontario, Canada, L1S 2J5

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

George Philteos

GSK Investigational Site

Recruiting

Québec, Quebec, Canada, G1V 4T3

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Caroline Rheaume

GSK Investigational Site

Recruiting

Trois-Rivières, Quebec, Canada, G8T 7A1

Contacts

US GSK Clinical Trials Call Center

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Centre

+44 (0) 20 8990 4466 GSKClinicalSupportHD@gsk.com

Principal Investigator:

Pierre-Alexandre Menard

More Information

Sponsor

GlaxoSmithKline

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Keywords

Asthma
Bronchospasm
Hydrofluoroalkane
Metered dose inhaler
Propellant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-10. This information was provided to ClinicalTrials.gov by GlaxoSmithKline on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.