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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants receiving HFA-152a followed by HFA-134a | Experimental | 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. |
|
| Participants receiving HFA-134a followed by HFA-152a | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HFA-152a | Drug | HFA-152a will be administered. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events (AEs) | Up to 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with serious adverse events (SAEs) | Up to 8 weeks | |
| Absolute values for vital sign parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury [mmHg]) | At Days 1 and 15 |
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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:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| US GSK Clinical Trials Call Center | Contact | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
| EU GSK Clinical Trials Call Center | Contact | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D001986 | Bronchial Spasm |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| C063006 | norflurane |
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This will be a double blind study.
| HFA-134a | Drug | HFA-134a will be administered. |
|
| Absolute values for vital sign parameter: Pulse rate | At Days 1 and 15 |
| Change from Baseline in vital sign parameters: SBP and DBP (mmHg) | Baseline and Day 15 |
| Change from Baseline in vital sign parameter: Pulse rate | Baseline and Day 15 |
| Absolute values for QT Interval Corrected (QTc) from 12 Lead Electrocardiogram (ECG) | At Days 1 and 15 |
| Absolute values for Heart Rate (HR) from 12 Lead ECG | At Days 1 and 15 |
| Change from Baseline in QTc using 12 lead ECG | Baseline and Day 15 |
| Change from Baseline in heart rate using 12 Lead ECG | Baseline and Day 15 |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |