NCT07645248招募中3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 15
- 主要终点
- Number of participants with adverse events (AEs)
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This will be a double blind study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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).
研究组 & 干预措施
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.
干预措施: HFA-152a (Drug)
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.
干预措施: HFA-134a (Drug)
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.
干预措施: HFA-152a (Drug)
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.
干预措施: HFA-134a (Drug)
结局指标
主要结局
Number of participants with adverse events (AEs)
时间窗: Up to 8 weeks
次要结局
- Absolute values for Heart Rate (HR) from 12 Lead ECG(At Days 1 and 15)
- Change from Baseline in QTc using 12 lead ECG(Baseline and Day 15)
- Change from Baseline in heart rate using 12 Lead ECG(Baseline and Day 15)
- Number of participants with serious adverse events (SAEs)(Up to 8 weeks)
- Absolute values for QT Interval Corrected (QTc) from 12 Lead Electrocardiogram (ECG)(At Days 1 and 15)
- 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)
研究者
研究点 (15)
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