NCT01778062已完成3 期
A Phase Ⅲb, Multicenter, Double-blind, Randomized, Controlled Trial, to Assess the Efficacy and Safety of Indacaterol (150㎍ o.d.) vs. Placebo, in Patients With Moderate-to-severe COPD With Destroyed Lung by Tuberculosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Trough Forced Expiratory Volume in One Second Change
研究概览
简要总结
This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with Chronic Obstructive Pulmonary Disease (COPD) with destroyed lung by tuberculosis.
详细描述
There are few clinical studies in patients with COPD with destroyed lung by tuberculosis because tuberculosis patients are usually excluded from (phase II or III) clinical trials for drug registration although they are not prohibited from prescription of COPD drugs.
This clinical study will assess efficacy and safety of indacaterol (150㎍ o.d.) in patients with COPD with destroyed lung by tuberculosis.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged ≥ 19 years in international age
- •Patients with a diagnosis of moderate-to-severe COPD as classified by the GOLD guidelines (2009)
- •Patients with at least one finding of destructed pulmonary parenchyma in the chest X-ray and the sum of all legion volumes equivalent to over 1/3 of one lung
- •Patients with a history of tuberculosis and no change in the chest imaging test over the past one year
- •Patients who can voluntarily sign an Informed Consent Form prior to initiation of any study-related procedure
排除标准
- •Pregnant or nursing (lactating) women
- •Women of childbearing potential not willing to use effective contraception. However, those who have a negative pregnancy test and agree to use effective contraception can participate. Effective contraception does not include periodical abstinence (e.g. basal body temperature, menstrual cycle contraceptive method, etc) but means use of contraception which must include one of barrier contraceptive methods.
- •e.g.) condom (barrier contraceptive method), diaphragms (barrier contraceptive method), oral contraceptives, intrauterine device, Depo injection, etc.
- •Patients who have been admitted to hospital for COPD worsening within 6 weeks prior to visit 1
- •Patients with a history of respiratory infection within 6 weeks prior to visit 1
- •Patients requiring long-term oxygen therapy (>15 hours/1 day) for chronic hypoxemia (it is allowed to use up to a total of 10 out of 24 hours on a PRN basis)
- •Patients with a history of asthma
- •Unstable ischaemic heart disease, arrhythmia (except for stable ventricular fibrillation) and uncontrolled hypertension
- •Patients with a history of long QT syndrome or whose QTc interval measured at Visit 2 is prolonged: >450 ms (males) or >470 ms (females)
- •Uncontrolled hypothyroidism and hyperthyroidism
- •Hypokalemia: plasma potassium level < 3.0 mEq/L
- •Patients with creatinine level ≥2 the upper limit of normal
- •Patients with AST/ALT level ≥2 the upper limit of normal
- •Patients with lung cancer or a history of lung cancer
- •Patients with active cancer or a history of cancer with less than 5 years disease-free survival (whether or not there is evidence of local recurrence or metastases; localized basal cell carcinoma of the skin without metastases is acceptable).
- •Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
- •Patients who have had live attenuated vaccinations within 30 days prior to Visit 1
- •Patients who have had treatment with investigational drugs, within 30 days or 5 half-lives prior to Visit 1, whichever is longer.
- •Patients unable to successfully use a dry powder inhaler device, metered dose inhaler or perform spirometry measurements
- •Other cases which are considered ineligible for this clinical study by the principal investigator and subinvestigator
研究组 & 干预措施
Indacaterol
Experimental
Indacaterol 150 µg once daily
干预措施: Indacaterol (Drug)
Placebo
Placebo Comparator
Placebo once daily
干预措施: Control (Drug)
结局指标
主要结局
Trough Forced Expiratory Volume in One Second Change
时间窗: 8 week
Spirometry was conducted according to internationally accepted standards. Trough FEV1 was defined as the average of the 23 hour 10 minute and 23 hour 45 minute post-dose FEV1 readings. Mixed model used baseline FEV1, FEV1 prior to and 10-15 minutes post inhalation of albuterol, and FEV1 prior to and 1 hour post inhalation of ipratropium as covariate
次要结局
- Change From Baseline in Transition Dyspnea Index (TDI) After 8 Weeks of Treatment(8 week)
- Incidence of COPD Exacerbation(8 week)
- St. George Respiratory Questionnaire for COPD (SGRQ-C) Change After 8 Weeks of Treatment(8 week)
研究者
研究点 (1)
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