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)

NCT07645248 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 223957
• Study Type: interventional
• Target: 110
• Locations: 0 countries
• Sites: N/A

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

Keywords

Asthma; Bronchospasm; Hydrofluoroalkane; Metered dose inhaler; Propellant

Outcome Measures

Primary Outcomes (1)

• Number of participants with adverse events (AEs)

  Up to 8 weeks

Secondary Outcomes (9)

• 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

• 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

Study Arms (2)

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.

Drug: HFA-152a; Drug: HFA-134a

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.

Drug: HFA-152a; Drug: HFA-134a

Interventions

HFA-152a DRUG

HFA-152a will be administered.

Participants receiving HFA-134a followed by HFA-152a; Participants receiving HFA-152a followed by HFA-134a

HFA-134a DRUG

HFA-134a will be administered.

Participants receiving HFA-134a followed by HFA-152a; Participants receiving HFA-152a followed by HFA-134a

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Asthma; Bronchial Spasm

Interventions

norflurane

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This will be a double blind study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): September 15, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): February 25, 2027
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 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.
• Access Criteria: 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.