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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)

2026年11月3日 更新者：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).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

110

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

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).

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：四人间

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
药品：HFA-152a

HFA-152a will be administered.

药品：HFA-134a

HFA-134a will be administered.
实验性的：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.
药品：HFA-152a

HFA-152a will be administered.

药品：HFA-134a

HFA-134a will be administered.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Number of participants with adverse events (AEs)
大体时间：Up to 8 weeks
Up to 8 weeks

次要结果测量

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

GlaxoSmithKline

调查人员

  • 研究主任：GSK Clinical Trials、GlaxoSmithKline

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年9月1日

初级完成 (估计的)

2026年12月28日

研究完成 (估计的)

2026年12月28日

研究注册日期

首次提交

2026年6月8日

首先提交符合 QC 标准的

2026年6月8日

首次发布 (实际的)

2026年6月12日

研究记录更新

最后更新发布 (实际的)

2026年11月5日

上次提交的符合 QC 标准的更新

2026年11月3日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 223957

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

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 共享时间框架

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.

IPD 共享访问标准

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 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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