Last updated: 09/29/2026 06:31:38
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)
GSK study ID
223957
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: A randomized, double-blind, 2-way crossover, multicenter study to evaluate the safety of test propellant HFA-152a and reference propellant HFA-134a when administered via metered dose inhalers
Trial description: 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).
Primary purpose:
Treatment
Trial design:
Cross-over
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Number of participants with adverse events (AEs)
Timeframe: Up to 8 weeks
Secondary outcomes:
Number of participants with serious adverse events (SAEs)
Timeframe: Up to 8 weeks
Absolute values for vital sign parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury [mmHg])
Timeframe: At Days 1 and 15
Absolute values for vital sign parameter: Pulse rate
Timeframe: At Days 1 and 15
Change from Baseline in vital sign parameters: SBP and DBP (mmHg)
Timeframe: Baseline and Day 15
Change from Baseline in vital sign parameter: Pulse rate
Timeframe: Baseline and Day 15
Absolute values for QT Interval Corrected (QTc) from 12 Lead Electrocardiogram (ECG)
Timeframe: At Days 1 and 15
Absolute values for Heart Rate (HR) from 12 Lead ECG
Timeframe: At Days 1 and 15
Change from Baseline in QTc using 12 lead ECG
Timeframe: Baseline and Day 15
Change from Baseline in heart rate using 12 Lead ECG
Timeframe: Baseline and Day 15
Interventions:
Drug: HFA-152a
Drug: HFA-134a
Enrollment:
110
Primary completion date:
2027-25-02
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Asthma
Product
Not applicable
Collaborators
Not applicable
Study date(s)
September 2026 to February 2027
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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:
- 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.
Inclusion and exclusion 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: o 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: o Is a Participant of nonchildbearing potential (PONCBP) or o 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).
Trial location(s)
Location
GSK Investigational Site
Greater Manchester, United Kingdom, OL6 6EW
Status
Recruiting
Location
GSK Investigational Site
Great Cambourne, Cambridge, United Kingdom, CB23 6HL
Status
Recruiting
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1426
Status
Recruiting
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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