CTRI/2022/01/039634已完成不适用
A Multicentre, Randomized, Double Blind, Double-Dummy, Three-period, Six-Sequence, Crossover, Active and Placebo Controlled, Single Dose Pharmacodynamic Study to Evaluate Therapeutic Equivalence of Test Formulation Tiotropium Bromide Inhalation Powder to Reference Formulation SPIRIVA® HANDIHALER® (Tiotropium bromide inhalation powder) in participants with Chronic Obstructive Pulmonary Disease.
Phargentis SA19 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年5月26日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 19
- 主要终点
- Following Pharmacodynamic parameters will be evaluated: Primary PD parameter: Baseline-adjusted area under the serial FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment.
研究概览
简要总结
This study is A Multicentre,Randomized, Double Blind, Double-Dummy, Three-period, Six-Sequence, Crossover,Active and Placebo Controlled, Single Dose Pharmacodynamic Study, to EvaluateTherapeutic Equivalence of Test Formulation Tiotropium Bromide InhalationPowder to Reference Formulation of Tiotropium bromide inhalation powder inparticipants with Chronic Obstructive Pulmonary Disease. This study have 3phase Screening period,Placebo run-in period and Double blind treatment phase (single dose in eachperiod) At the randomization visit, participants who meet all of theeligibility criteria will be randomised 1:1:1 to receive single dose (2inhalations from the same capsule per device; a total of 4 inhalations from 2devices) of test, reference or placebo during each period. After dosing atspecified time point’s spirometry will be done to assess the FEV1 during eachperiod. To characterize thepharmacodynamic characteristics and to assess the therapeutic bioequivalence and Superiority after single dose of Tiotropium BromideInhalation Powder-test and Tiotropium Bromide Inhalation Powder-reference overplacebo in Adult Patients with Chronic Obstructive Pulmonary Disease (COPD).
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Double Blind Double Dummy
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for the study in this protocol and is willing to participate in the study.
- •Male or female participant must be of ≥ 40 years of age, at the time of signing the informed consent.
- •Participants who are medically stable on the basis of physical examination, medical history, and vital signs, chest X-ray and 12-lead ECG performed at screening.
- •Any abnormalities, must be consistent with the underlying illness in the study population and this determination must be recorded in the participants source documents and initialed by the investigator.
- •Participants with documented Diagnosis of COPD, as defined by American Thoracic Society (ATS) [GOLD criteria] at screening.
- •Pre-bronchodilator FEV1 ≥ 35% and ≤ 80% of predicted at screening and visits 3-
- •At visits 3-5, the average of the quality FEV1 measurements will be used to determine the baseline FEV1, and must be ≥ 35% and ≤ 80% of predicted normal value and may not vary by more than ± 20% from the qualifying screening visit FEV1 value.
- •Participant must demonstrate at screening, post-bronchodilator FEV1≤80% of predicted.
- •Participant must demonstrate at screening, post-bronchodilator FEV1/FVC ratio ≤0.
- •Participant demonstrate ≥ 15 % reversibility of FEV1 within 45 minutes following 4 inhalations of ipratropium bromide HFA inhalation aerosol (84 mcg) at Screening.
- •10.Participants must administer at least 70% doses of placebo during the run-in period.
- •Participants who are Current or former cigarette smokers with a history of cigarette smoking of ≥10 pack-years at Screening (visit 1) Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1 12.A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: a.
- •Is not a woman of childbearing potential (WOCBP) b.
- •Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 15 days until after the last dose of study intervention.
- •The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
- •A WOCBP must have a negative highly sensitive serum pregnancy test at screening and negative urine pregnancy test prior to dosing of period I.
- •Participants willing and able to adhere to the lifestyle restrictions specified in this protocol.
- •14.Participants able to understand and comply with the study procedures, in the opinion of the investigator.
排除标准
- •Any potential participant who meets any of the following criteria will be excluded from participating in the study:
- •Participants with history of liver or renal insufficiency (estimated creatinine clearance below 60 mL/min); significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances.
- •Known respiratory disorder other than COPD, including but not limited to the following: active tuberculosis, lung cancer, alpha-1-antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema or interstitial lung disease.
- •Participants with α1-antitrypsin deficiency as the underlying cause of COPD at screening.
- •Participants with history of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hypertrophy, or bladder neck obstruction, which, in the investigator’s opinion, would contraindicate the use of an anticholinergic agent.
- •Participants with history of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agent, beta-2 adrenergic agonists, lactose/milk proteins or specific intolerance to aerosolized tiotropium or ipratropium bromide-containing products or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
- •Participants with use of oral/parenteral corticosteroids or antibiotics for COPD within 6 weeks or depot corticosteroids within 3 months prior to screening.
- •Participants with hospitalization for COPD or pneumonia within 12 weeks prior to study screening and randomization.
- •Participants with treatment for COPD exacerbation within 12 weeks prior to study screening and randomization.
- •Participants with acute (viral or bacterial) upper or lower respiratory tract infection include sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 6 weeks prior to screening.
- •Patients with sign and/or symptoms suggestive of COVID 19 infection at the time of screening.
- •Participants with lung volume reduction surgery within the previous 12 months of randomization.
- •Participants with chronic oxygen uses for >12 hours/day.
- •Participants with evidence or history of other clinically significant disease or abnormal (such as congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, stroke, glaucoma or cardiac dysrhythmia) condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
- •Participants had major surgery, (e.g., requiring general anesthesia) within 8 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study.
- •Participants with history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening.
- •Participants with history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening.
- •Participant is unable to stop the medications at the defined times prior to screening spirometry.
- •Participants with history of drug or alcohol abuse within 1 years before screening or positive test result(s) for alcohol or drugs of abuse at Screening.
- •Intended use of over the counter or prescription medication including herbal medications within 14 days prior to dosing.
- •Participants received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to baseline, whichever is longer, before the signing the consent or is currently enrolled in an investigational study.
- •Participants who are medically unable to withhold their salbutamol for the at least 4-hour period required prior to spirometry testing at each study visit.
- •Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 2 weeks after the last dose of study intervention.
- •Plans to father a child while enrolled in this study or within 2 weeks after the last dose of study intervention.
- •Participants that experiences a moderate or a severe COPD exacerbation or pneumonia during the run-in period will be excluded.
- •Participants requires nocturnal oxygen or continuous supplemental oxygen therapy.
- •Participant that requires a change in COPD medication from rescue medication or participants required rescue medications more than acceptable frequency (two inhalations every 4 to 6 hours) during the screening or run-in period will be excluded.
- •Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator.
- •Participants unable to perform maneuver (correct inhalation technique) according to study requirement despite of giving device training as per investigator discretion.
- •Participants unable to perform acceptable or repeatable spirometry or comply with other study procedures.
结局指标
主要结局
Following Pharmacodynamic parameters will be evaluated: Primary PD parameter: Baseline-adjusted area under the serial FEV1-time curve calculated from time 0 to 24 hours (AUC0-24h) following treatment.
时间窗: 24 Hours
Baseline FEV1 is defined as the average of at least two quality pre-dose FEV1 values.
时间窗: 24 Hours
次要结局
- Following Pharmacodynamic parameters will be(evaluated:)
研究者
研究点 (19)
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