NCT07645248 A Study to Compare Safety of 4 Weeks Exposure to Propellants Hydrofluoroalkane 1,1-difluoroethane (HFA-152a) and HFA-1,1,1,2-tetrafluoroethane (134a)
| NCT ID | NCT07645248 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | GlaxoSmithKline |
| Condition | Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 110 participants |
| Start Date | 2026-09-01 |
| Primary Completion | 2026-12-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 110 participants in total. It began in 2026-09-01 with a primary completion date of 2026-12-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
Eligibility Criteria
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).
Contact & Investigator
GSK Clinical Trials
STUDY DIRECTOR
GlaxoSmithKline
Frequently Asked Questions
Who can join the NCT07645248 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07645248 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 110 participants.
Is NCT07645248 currently recruiting?
Yes, NCT07645248 is actively recruiting participants. Contact the research team at GSKClinicalSupportHD@gsk.com for enrollment information.
Where is the NCT07645248 trial being conducted?
This trial is being conducted at Aventura, United States, Miami, United States, Miami, United States, Naples, United States and 11 additional locations.
Who is sponsoring the NCT07645248 clinical trial?
NCT07645248 is sponsored by GlaxoSmithKline. The principal investigator is GSK Clinical Trials at GlaxoSmithKline. The trial plans to enroll 110 participants.
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