A Randomized, Multicenter, Multiple-dose, Double-blind, Placebo-controlled, Parallel-group Design, Clinical Endpoint Bioequivalence Study to Evaluate the Therapeutic Equivalence and Safety of Fluticasone Furoate and Vilanterol Inhalation Powder 100 mcg/25 mcg (Sandoz) and BREO® ELLIPTA® (Fluticasone Furoate and Vilanterol Inhalation Powder) 100 mcg/25 mcg (GlaxoSmithKline) in Adult Participants With Asthma
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- Sandoz
- 入组人数
- 1,430
- 试验地点
- 6
- 主要终点
- Demonstrate the therapeutic equivalence of test and reference product
研究概览
简要总结
This is a randomized, multi-center, multiple-dose, double-blind, placebo-controlled, Parallel group design, clinical endpoint bioequivalence study in adult participants with asthma.
The study design includes up to a 2-week Screening period, at least a 2-week Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1: Screening Visit 2: Run-in period: All eligible participants will enter a 2-week Run-in period in which training will be provided to the participants on the use of inhalers and participant diary.
Visit 3: Day 1: Randomization to one of the 3 treatment groups to receive one inhalation of the study medication quaque die (QD), in the morning, for 28 ± 2 days.
Visit 4: Day 28: EOT
Participants will be contacted one week after their last site visit for Safety follow-up via phone call (end of study). Participants will be instructed to refrain from taking their current inhaled asthma medications from the start of the Run-in period until the end of treatment (EOT) visit. They will be provided with a salbutamol/albuterol inhaler (rescue medication) for use on an as-needed basis during the entire study duration until the EOT visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Capable of giving signed informed consent (as described in the protocol), which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- •Participants must be 18 to 75 years old (inclusive) at Screening (signing the ICF).
- •Diagnosis of asthma, as defined by the National Asthma Education and Prevention Program, at least 12 weeks prior to Screening.
- •Participants who are stable on their chronic asthma treatment regimen for at least 4 weeks prior to Screening.
- •Pre-bronchodilator FEV1 of >40% and <85% of predicted value, at Screening.
- •Participants with FEV1 reversibility of ≥12% and ≥200 mL within 30 minutes following 360 mcg of albuterol inhalation (via pressurized metered dose inhaler pressurized metered-dose inhaler [pMDI]) or equivalent at Screening.
- •This what you mean: Participants who are currently non-smoking and have not used tobacco smoking or smoked marijuana products, within the past year.
- •Participants who are able to replace their current regularly scheduled short-acting β2-agonists (SABAs) with a salbutamol/albuterol inhaler for use only on an 'as-needed' basis for the duration of the study.
- •Participants must be able to discontinue their asthma medications during the Run-in period, and for the remainder of the study.
- •Participants who can demonstrate the correct use of inhaler device (during the Run-in period and at Randomization visit).
- •Participants are eligible to participate in this study if they are:
- •Of non-childbearing potential
- •Of childbearing potential, and if they agree to use a highly effective form of contraception consistently during the study, starting at Screening and until the end of study (EOS). These participants must have a negative pregnancy test at Screening and Randomization visit.
- •Participants who produce viable sperm and have a partner of childbearing potential, and if they agree to use an adequate method of contraception consistently during the study, starting at Screening and until the EOS and also refrain from donating sperm during this period. Participants with a partner or partners who is (are) not of childbearing potential are exempt from these requirements.
排除标准
- •Participants who have life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within one year prior to Screening or during the Run-in period.
- •Participants with significant chronic respiratory disease (COPD, interstitial lung disease, etc) other than asthma which in the opinion of the Investigator may interfere with the study evaluation or optimal participation in the study.
- •Participants with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, cardiac dysrhythmia, significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the Investigator, would put them at risk through study participation, or would affect the study analyses if the disease exacerbated during the study.
- •Participants with asthma exacerbations (ie, acute or sub-acute worsening in symptoms and lung function from the participant's usual status) within 6 weeks prior to Screening or during the Run-in period.
- •Participants with evidence or history of tuberculosis (additionally confirmed with a chest X-ray done within 6 months prior to Screening for countries with high tuberculosis risk).
- •Participants with uncontrolled allergic rhinitis within 15 days prior to Screening.
- •Viral, bacterial, fungal, or parasitic, acute upper or lower respiratory tract infection (including Coronavirus Disease (COVID-19)), or sinus, or middle ear infection within 4 weeks prior to Screening, during the Run-in period, or at the Randomization visit. Note: Rescreening of participants with acute respiratory conditions during the Screening and Run-in period may be allowed in consultation with Medical Monitor (Section 5.4).
- •Participants with a history of hepatitis B, hepatitis C, or human immunodeficiency virus 1 and
- •Participants with clinically significant screening laboratory and electrocardiogram (ECG) parameters as per Investigator's assessment.
- •Participants receiving systemic, oral, parenteral or depot corticosteroids, or anti-immunoglobulin E (IgE) therapy within 12 weeks prior to Screening spirometry or unable to stop receiving these medications during the study.
- •Participants receiving β2-blockers, anti-arrhythmics, anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3 subfamily A member 4 (3A4) inhibitors, or diuretics within 4 weeks prior to the Screening spirometry or unable to stop receiving these medications during the study.
- •Participants receiving monoclonal antibodies that may affect the course of asthma within 180 days prior to the Screening spirometry or unable to stop receiving these medications during the study.
- •Participants receiving live attenuated vaccines within two days prior to Screening.
- •Participants who received an investigational drug within 28 days or 5 half-lives (whichever is longer) prior to Screening.
- •Hypersensitivity to any sympathomimetic drug (eg, albuterol, vilanterol) or to any inhaled, intranasal, or systemic corticosteroid therapy, or to milk proteins, or to excipients in the dry powder inhaler.
- •Participants with significant alcohol or controlled substance abuse in the past 6 months, per the judgment of the Investigator.
- •Participants with any factors (eg, infirmity, disability, or geographic location) that the Investigator feel would likely limit the participants' compliance with the study protocol or scheduled clinic visits.
- •Participants who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator.
- •Participants who are pregnant, breastfeeding, or planning to become pregnant during the study.
研究组 & 干预措施
Placebo
Placebo QD for 4 weeks
干预措施: Placebo (Combination Product)
Fluticasone furoate and vilanterol inhalation powder
Fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks
干预措施: Fluticasone furoate and vilanterol inhalation powder (Combination Product)
Breo Ellipta
Fluticasone furoate and Vilanterol inhalation powder 100 mcg/25 mcg QD for 4 weeks
干预措施: Breo Ellipta (Combination Product)
结局指标
主要结局
Demonstrate the therapeutic equivalence of test and reference product
时间窗: Day 28 of treatment
trough Forced Expiratory Volume in 1 Second (FEV1 on Day 28)
Demonstrate the superiority of test and reference product over placebo
时间窗: Day 28 of treatment
trough Forced Expiratory Volume in 1 Second (FEV1 on Day 28)
Demonstrate the therapeutic equivalence of test and reference product
时间窗: Day 1 (0-24Hrs)
Forced Expiratory Volume in 1 Second (FEV1) Are Under Curve (AUC 0-24) on Day 1
Demonstrate the superiority of test and reference product over placebo
时间窗: Day 1 (0-24 hours (Hrs)
Forced Expiratory Volume in 1 Second (FEV1) Are Under Curve (AUC 0-24) on Day 1
次要结局
- To compare the number and type of Adverse Events of Test, Reference and Placebo(Screening to week 5 (End of study))