CTRI/2023/01/049303已完成不适用
A Multicenter, Randomized, Placebo-Controlled, Crossover, Single Dose Study to Demonstrate Clinical Pharmacodynamic Bioequivalence of Tiotropium 18 mcg Inhalation Powder, Hard Capsule with Spiriva Handihaler 18 mcg Inhalation Powder, Hard Capsule in Patients with Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 15
- 主要终点
- The area under the serial FEV1-time curve (baseline adjusted) calculated from time 0 to 24 hours (i.e., AUC0-24h) after the single dose of the treatment. Baseline is considered the pre dose FEV1 value on the day of treatment (Visit 3) prior to taking the single dose of the assigned treatment.
研究概览
简要总结
This study is a multicenter,randomized, placebo-controlled, crossover, single dose study to demonstrateclinical pharmacodynamic bioequivalence of tiotropium 18 μg inhalation powder,hard capsule with spiriva®handihaler® 18 μg inhalation powder, hard capsule inpatients with chronic obstructive pulmonary disease (COPD). This study has 3phases - Screening period, Washoutperiod and treatment phase (single dose in each period). At the randomizationvisit, participants who meet all of the eligibility criteria will be randomisedto receive single dose of either test, reference or placebo during each period.After dosing at specified time point’s spirometry will be done to assess theFEV1 during each period, to characterize the pharmacodynamic 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
- Not Applicable
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the Investigator, capable of giving written informed consent and being compliant with all study requirements (visits, study procedures such as pulmonary function tests, record-keeping, etc.).
- •2.Male or non-pregnant female patients between 40 to 75 years of age at Screening Visit (Visit 1) diagnosed with COPD who have signed informed consent prior to initiation of any study-related procedure.
- •3.General good health (except the COPD diagnosis) and free of any concomitant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as per the discretion of the Investigator.
- •4.An established physician diagnosis of COPD as defined by the American Thoracic Society 5.At first (Visit 1) or second (Visit 2) Screening Visit, post-bronchodilator FEV1≤80% and ≥40% of predicted normal values as per Global Lung Function Initiative (GLI-2012) after 4 puffs of albuterol used as per GOLD
- •Additionally, post-bronchodilator FEV1/FVC ratio ≤0.
- •6.Pre dose FEV1 values at Visits 4 and 5 within ± 20% of the Visit 3 FEV
- •7.Able to perform spirometry according to the defined acceptability and reproducibility criteria at the Screening Visit (Visit 1 or 2).
- •8.Current COPD Therapy: Patients must be on stable regimens of one of the following for at least 8 weeks prior to screening (Visit 1): •Long-acting beta-agonist (LABA) •Long-acting muscarinic antagonist (LAMA) •LAMA+LABA •Inhaled corticosteroids + LABA •Inhaled corticosteroids + LAMA •Short-acting beta-agonist (SABA) 9.All patients must be able to replace their current short-acting bronchodilators with study-provided albuterol inhalation aerosol provided at the Screening Visit (Visit 1) for use as needed for the duration of the study.
- •10.Patients must be able to discontinue their COPD maintenance medications during the run-in and treatment periods.
- •11.Patients must be able to withhold their short-acting β2-agonists for at least 6 hours prior to spirometry on each clinic visit at the discretion of the investigator.
- •12.Current or ex-smokers with ≥10 pack-year smoking history 13.Female patients may be of non-childbearing potential (postmenopausal, i.e., amenorrheal for >2 consecutive years, or naturally postmenopausal [no menses] for ≥1 year; surgically sterile [tubal ligation, bilateral oophorectomy, or hysterectomy], congenital sterility, or diagnosed as infertile and not undergoing treatment to reverse infertility) or if of childbearing potential committed to the consistent and correct use of an acceptable method of birth control and demonstrate a negative pregnancy test at the Screening Visit (Visit 1) and during the study.
- •14.Male subjects, who are sexually active, committed to the consistent and correct use of an acceptable method of birth control for the duration of the study, and/or exclusively have same-sex partners.
- •15.No occurrence of an upper or lower respiratory tract infection during the run-in period.
- •16.No COPD exacerbation, defined as any worsening of COPD requiring an emergency department visit or hospitalization, or requiring excessive use of the albuterol rescue medication (more than 3 puffs per day increase from the average daily usage) during the run-in and/or treatment period at the discretion of the Investigator, or the use of antibiotics and/or corticosteroids during the run-in period and/or treatment period.
- •17.Patients should be able to tolerate the withdrawal of COPD medications during the study at the discretion of the Investigator.
- •18.Patient must be able to demonstrate a consistent inspiratory flow rate (≥ 40 L/min), three times consecutively using the In-Check DIAL device, mimicking the HandiHaler device setting.
- •19.The patient has completed diary data on a minimum of 5 days out of the last 7 days prior to randomization (not including the day of randomization) and has achieved a minimum of 70% compliance with the paper diary during the run-in period.
排除标准
- •1.Treatment for COPD exacerbation within 12 weeks prior to the Screening Visit (Visit 1) or 2 or more exacerbations in the last year.
- •2.Hospitalization for COPD or pneumonia within 12 weeks prior to the Screening Visit (Visit 1).
- •3.History of a life-threatening COPD episode that required intubation and/or was associated with hypercapnia, respiratory arrest, hypoxic seizures, or mMRC (Modified Medical Research Council) dyspnea Grade
- •4.Acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, rhinitis, pharyngitis, urinary tract infection or illness within 8 weeks prior to the Screening Visit (Visit 1).
- •5.Use of immediate-release (Oral or IV) corticosteroids within the last 30 days and/or extended-release corticosteroids (Depot or Local) within the last 12 weeks prior to the Screening Visit (Visit 2).
- •6.Patients with a history of asthma or a clinical diagnosis of asthma, allergic rhinitis, or atopy; a total blood eosinophil count above 600/mm
- •7.Patients with an abnormal/clinically significant 12-lead electrocardiogram (ECG) prior to and during screening visit, during the run-in and treatment periods.
- •8.Patients with myocardial infarction or unstable angina in the last 12 months; unstable or life-threatening cardiac arrhythmia requiring intervention in the last 12 months; or New York Heart Association Class II-IV heart failure.
- •9.Patients with documented pulmonary hypertension or clinical signs of right heart failure (indicated by an increase in jugular venous pressure with or without peripheral edema) or patients who require chronic oxygen use for >12 hours per day.
- •10.Presence of glaucoma or a history/family history of glaucoma.
- •11.History of paradoxical bronchospasm, narrow-angle glaucoma, prostatic hyperplasia, bladder-neck obstruction, or any other condition, which, in the opinion of the Investigator, would contraindicate the use of an anticholinergic agent.
- •12.Presence or history of urinary retention.
- •13.Historical or current evidence of a clinically significant disease (Note: Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the patient at risk through participation, or which could affect the efficacy or safety analysis if the disease/condition exacerbated during the study) including, but not limited to: •Cardiovascular (e.g., congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, stroke, or non-controlled arrhythmias), •Hepatic, renal, hematological, neuropsychological, endocrine (e.g., uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison’s disease, and Cushing’s syndrome), •Gastrointestinal (e.g., poorly-controlled peptic ulcer disease), •Pulmonary disease other than COPD (e.g., alpha-1 antitrypsin deficiency, active bronchiectasis, cystic fibrosis, broncho-pulmonary dysplasia, sarcoidosis, lung fibrosis, pulmonary edema, interstitial lung disease, lung or mediastinum proliferative process including malignancies).
- •15.Have any of the following conditions that, in the judgment of the Investigator, might cause participation in this study to be detrimental to the patient, including but not limited to: •Current malignancy excluding basal cell carcinoma.
- •(Note: History of malignancy is acceptable only if the patient has been in remission for one year prior to the Screening Visit (Visit 1).
- •Remission is defined as no current evidence of malignancy and no treatment for the malignancy in the 5 years prior to the Screening Visit (Visit 1).
- •â€¢Current or untreated tuberculosis (Note: History of tuberculosis is acceptable only if a patient has received an approved prophylactic treatment regimen or an approved active treatment regimen and has had no evidence of active disease for a minimum of 2 years).
- •â€¢Uncontrolled hypertension (systolic blood pressure [BP] ≥160 or diastolic BP >100).
- •â€¢Immunocompromised 16.A patient must not have any clinically significant, uncontrolled condition, or disease state that, in the opinion of the Investigator, would put the safety of the patient at risk through study participation or would confound the interpretation of the efficacy results if the condition/disease exacerbated during the study.
- •17.History of allergy or hypersensitivity to anticholinergic/muscarinic receptor antagonist agents, beta-2 adrenergic agonists, lactose/milk proteins, or specific intolerance to aerosolized tiotropium-containing products or its derivatives (e.g., ipratropium, oxitropium), or known hypersensitivity to any of the proposed ingredients or components of the delivery system.
- •18.History of alcohol or drug abuse within 2 years prior to the Screening Visit (Visit 1).
- •19.Study participation by the clinical Investigator, site employees and/or their immediate relatives.
- •21.Legal incapacity or other circumstances that render the patient unable to understand the nature, scope and possible consequences of the study.
结局指标
主要结局
The area under the serial FEV1-time curve (baseline adjusted) calculated from time 0 to 24 hours (i.e., AUC0-24h) after the single dose of the treatment. Baseline is considered the pre dose FEV1 value on the day of treatment (Visit 3) prior to taking the single dose of the assigned treatment.
时间窗: 24 Hours
Two spirometry FEV1 assessments (at -60 min and -30 min pre-dose) will be performed according to ATS standards, 30 (±5) min apart. The average of the two readings will be considered as baseline FEV1.
时间窗: 24 Hours
次要结局
- The maximum FEV1 response (difference between peak FEV1 and FEV1 at baseline (pre-dose)).(24 Hours)
研究者
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