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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)

8. juni 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Studietype

Intervensjonell

Registrering (Antatt)

110

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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).

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Firemannsrom

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
HFA-152a will be administered.
HFA-134a will be administered.
Eksperimentell: 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.
HFA-152a will be administered.
HFA-134a will be administered.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Number of participants with adverse events (AEs)
Tidsramme: Up to 8 weeks
Up to 8 weeks

Sekundære resultatmål

Resultatmål
Tidsramme
Number of participants with serious adverse events (SAEs)
Tidsramme: 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])
Tidsramme: At Days 1 and 15
At Days 1 and 15
Absolute values for vital sign parameter: Pulse rate
Tidsramme: At Days 1 and 15
At Days 1 and 15
Change from Baseline in vital sign parameters: SBP and DBP (mmHg)
Tidsramme: Baseline and Day 15
Baseline and Day 15
Change from Baseline in vital sign parameter: Pulse rate
Tidsramme: Baseline and Day 15
Baseline and Day 15
Absolute values for QT Interval Corrected (QTc) from 12 Lead Electrocardiogram (ECG)
Tidsramme: At Days 1 and 15
At Days 1 and 15
Absolute values for Heart Rate (HR) from 12 Lead ECG
Tidsramme: At Days 1 and 15
At Days 1 and 15
Change from Baseline in QTc using 12 lead ECG
Tidsramme: Baseline and Day 15
Baseline and Day 15
Change from Baseline in heart rate using 12 Lead ECG
Tidsramme: Baseline and Day 15
Baseline and Day 15

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Etterforskere

  • Studieleder: GSK Clinical Trials, GlaxoSmithKline

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. september 2026

Primær fullføring (Antatt)

25. februar 2027

Studiet fullført (Antatt)

25. februar 2027

Datoer for studieregistrering

Først innsendt

8. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

8. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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.

Tilgangskriterier for IPD-deling

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.

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere