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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)

3 novembre 2026 aggiornato da: GlaxoSmithKline

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

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).

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

110

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Argentina
      • Buenos Aires, Argentina, C1425AZE
        • Reclutamento
        • GSK Investigational Site
        • Investigatore principale:
          • Nicolas Itcovici
        • Contatto:
        • Contatto:
      • Ciudad Autonoma de Buenos Aire, Argentina, C1426
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Pablo Alexis Christian Doreski
      • Lujan de Cuyo, Argentina, 5509
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Cristian Fazio
  • Canada
    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Reclutamento
        • GSK Investigational Site
        • Investigatore principale:
          • George Philteos
        • Contatto:
        • Contatto:
    • Quebec
      • Québec, Quebec, Canada, G1V 4T3
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Caroline Rheaume
      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Reclutamento
        • GSK Investigational Site
        • Investigatore principale:
          • Pierre-Alexandre Menard
        • Contatto:
        • Contatto:
  • Regno Unito
      • Greater Manchester, Regno Unito, OL6 6EW
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Omair Razzaq
    • Cambridge
      • Great Cambourne, Cambridge, Regno Unito, CB23 6HL
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Rakesh Modi
  • Stati Uniti
    • Florida
      • Aventura, Florida, Stati Uniti, 33180
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Jaime Landman
      • Miami, Florida, Stati Uniti, 33155
        • Reclutamento
        • GSK Investigational Site
        • Investigatore principale:
          • Eduardo Martinez
        • Contatto:
        • Contatto:
      • Miami, Florida, Stati Uniti, 33173-3484
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Ileana Rodicio
      • Naples, Florida, Stati Uniti, 34102
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Lisette Delgado Sanchez
    • Kentucky
      • Owensboro, Kentucky, Stati Uniti, 42301
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Lee Clore
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65203
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Mark Vandewalker
    • Nevada
      • Henderson, Nevada, Stati Uniti, 89052-5015
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Vikas Sayal
    • Oregon
      • Medford, Oregon, Stati Uniti, 97504
        • Reclutamento
        • GSK Investigational Site
        • Investigatore principale:
          • Sarah Smiley
        • Contatto:
        • Contatto:
    • South Carolina
      • Spartanburg, South Carolina, Stati Uniti, 29303
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Charles Fogarty
      • Spartanburg, South Carolina, Stati Uniti, 29303-4225
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Investigatore principale:
          • Farhan Siddiqui
        • Contatto:
    • Texas
      • Cypress, Texas, Stati Uniti, 77429
        • Reclutamento
        • GSK Investigational Site
        • Investigatore principale:
          • Dileep Puppala
        • Contatto:
        • Contatto:
      • Tomball, Texas, Stati Uniti, 77375
        • Reclutamento
        • GSK Investigational Site
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Mustafa Naeem

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Droga: HFA-152a

HFA-152a will be administered.

Droga: HFA-134a

HFA-134a will be administered.
Sperimentale: 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.
Droga: HFA-152a

HFA-152a will be administered.

Droga: HFA-134a

HFA-134a will be administered.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
Number of participants with adverse events (AEs)
Lasso di tempo: Up to 8 weeks
Up to 8 weeks

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
Number of participants with serious adverse events (SAEs)
Lasso di tempo: Up to 8 weeks
Up to 8 weeks
Absolute values for vital sign parameters: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) (Millimeters of mercury [mmHg])
Lasso di tempo: At Days 1 and 15
At Days 1 and 15
Absolute values for vital sign parameter: Pulse rate
Lasso di tempo: At Days 1 and 15
At Days 1 and 15
Change from Baseline in vital sign parameters: SBP and DBP (mmHg)
Lasso di tempo: Baseline and Day 15
Baseline and Day 15
Change from Baseline in vital sign parameter: Pulse rate
Lasso di tempo: Baseline and Day 15
Baseline and Day 15
Absolute values for QT Interval Corrected (QTc) from 12 Lead Electrocardiogram (ECG)
Lasso di tempo: At Days 1 and 15
At Days 1 and 15
Absolute values for Heart Rate (HR) from 12 Lead ECG
Lasso di tempo: At Days 1 and 15
At Days 1 and 15
Change from Baseline in QTc using 12 lead ECG
Lasso di tempo: Baseline and Day 15
Baseline and Day 15
Change from Baseline in heart rate using 12 Lead ECG
Lasso di tempo: Baseline and Day 15
Baseline and Day 15

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

Investigatori

  • Direttore dello studio: GSK Clinical Trials, GlaxoSmithKline

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 settembre 2026

Completamento primario (Stimato)

28 dicembre 2026

Completamento dello studio (Stimato)

28 dicembre 2026

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

8 giugno 2026

Primo Inserito (Effettivo)

12 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

5 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 223957

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

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.

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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