CTRI/2025/12/098966尚未招募3 期
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.
Sandoz Private Limited, Sandoz Development Center, India35 个研究点 分布在 1 个国家目标入组 1,430 人开始时间: 2026年5月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,430
- 试验地点
- 35
- 主要终点
- To demonstrate the therapeutic equivalence of test and reference product
研究概览
简要总结
This is a randomized, multicenter, 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 placebo Run-in period, a 4-week Treatment period, and a safety follow up call one week later.
Visit 1 : Screening
Visit 2 : placebo Run-in period : All eligible particiapnts will enter a 2-week placebo Run-in period in which training will be provided to the participants on the use of inhalers (using placebo inhaler device) and participant diary.
Visit 3 : Day 1 : Randomization to one of the 3 treatment groups to receive one inhalation of the study medication 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
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Capable of giving signed informed consent, 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.
- •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 more than or equal to 40 percent and less than or equal to 85 percent of predicted value, at Screening.
- •Participants with FEV1 reversibility of more than or equal to 12 percent and more than or equal to 200 mL within 30 minutes following 360 mcg of albuterol inhalation (via pressurized metered dose inhaler) or equivalent at Screening.
- •Participants who are currently non-smoking and have not used tobacco products
- •Participants who are able to replace their current regularly scheduled short-acting agonists (SABAs) with a salbutamol/albuterol inhaler for use only on an as-needed basis for the duration 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: a) Of nonchildbearing potential b) Of childbearing potential, and if they agree to use a highly effective form of contraception as per the contraceptive guidance consistently during the study, starting at Screening and until the EOS.
- •These participants must have a negative pregnancy test at Screening and Randomization visit.
- •c) Participants who produce viable sperm and have a partner of childbearing potential, and if they agree to use an adequate method of contraception as per the contraceptive guidance 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.
- •Participants should not receive treatment for their asthma exacerbation with any prohibited medications listed in protocol.
排除标准
- •Participants who have life-threatening asthma, defined as a history of asthma episode requiring intubation, and or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes, or hospitalizations within one year prior to Screening or during the Run-in period.
- •Participants with significant chronic respiratory disease 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 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 within 6 weeks prior to Screening or during the Run-in period.
- •Participants with evidence or history of tuberculosis.
- •Participants with uncontrolled allergic rhinitis within 15 days prior to Screening.
- •Viral, bacterial, fungal, or parasitic, acute upper or lower respiratory tract infection(including COVID-19), or sinus, or middle ear infection within 4 weeks prior to Screening, during the Run-in period, or at the Randomization visit.
- •Participants with a history of hepatitis B, hepatitis C, or human immunodeficiency virus 1 and
- •Participants with clinically significant screening laboratory and electrocardiogram parameters as per Investigator’s assessment.
- •Participants receiving systemic, oral, parenteral or depot corticosteroids, or anti-IgE therapy within 12 weeks prior to Screening spirometry or unable to stop receiving these medications during the study.
- •Participants Beta2-blockers, anti-arrhythmics, anti-depressants, monoamine oxidase inhibitors, cytochrome P450 3A4 inhibitors, or diuretics within 4 weeks prior to the Screening spirometry or unable to stop receiving these medications during the study.
- •Participants who received an investigational drug within 28 days or 5 half-lives (whichever is longer) prior to Screening.
- •Hypersensitivity to any sympathomimetic drug like 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 like infirmity, disability, or geographic location that the Investigator feel would likely limit the participant 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.
结局指标
主要结局
To demonstrate the therapeutic equivalence of test and reference product
时间窗: -FEV1 AUC 0-24 h on Day 1 : FEV1 at pre-dose , 5 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 5 hours, 12 hours, 16 hours, 20 hours, 23 hours and 24 hours post dose. | -FEV1 on Day 28, Week 4 at pre-dose
次要结局
- To assess the safety and tolerability(-Adverse events from screening to Week 4,Day 28 (EOT))
研究者
研究点 (35)
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