A 26-Week Treatment, Multi-Center, Randomized, Double-Blind, Double- Dummy, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control

ovartis Health care Private Limited0 个研究点目标入组 972 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 972

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1.Male and female adults aged greater than or equal to 40 years, who have signed an Informed Consent Form prior to
•initiation of any study related procedure
•2. Co operative outpatients with a diagnosis of COPD (moderate to severe as classified by the
•GOLD Guidelines, 2006) and including:
•a) Smoking history of at least 20 pack years
•b) Post-bronchodilator FEV1 less than 80 percent and greater than or equal to 30 percent of the predicted normal value
•c) Post-bronchodilator FEV1 FVC less than 70 percent

排除标准

•1.Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum fhuman chorionic gonadotrophin laboratory test (greater than 5 mIU per mL)
•2. Women of child-bearing potential, defined as all women physiologically capable of
•becoming pregnant, including women whose career, lifestyle, or sexual orientation
•precludes intercourse with a male partner and women whose partners have been sterilized
•by vasectomy or other means, UNLESS they meet the following definition of postmenopausal.
•12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous
•amenorrhea with serum FSH levels greater than40 mIU per mL or are using one or more of the
•following acceptable methods of contraception.
•a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy)
•b) hormonal contraception (implantable, patch, oral)
•c) double-barrier methods (any double combination of. IUD, male or female condom
•with spermicidal gel, diaphragm, sponge, cervical cap)
•Acceptable methods of contraception may include total abstinence at the discretion of
•the investigator in cases where the age, career, lifestyle, or sexual orientation of the
•patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation,
•symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
•of contraception. Reliable contraception should be maintained throughout the study
•and for 30 days after study drug discontinuation
•3. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit
•1 or during the run-in period
•4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD
•exacerbation). This is typically patients requiring oxygen therapy greater than15 h per day delivered
•by home oxygen cylinder or concentrator.
•5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1. Patients
•who develop a respiratory tract infection between Visit 1 and Visit 3 must discontinue
•from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the
•start of the respiratory tract infection)
•6. Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed
•by chest x-ray to be no longer active) or clinically significant bronchiectasis
•7. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited
•a) blood eosinophil count greater than 400 per mm3
•b) onset of respiratory symptoms prior to age 40 years
•8. Patients with diabetes Type I or uncontrolled diabetes Type II including patients with a
•history of blood glucose levels consistently outside the normal range or HbA1C greater than 8.0 %
•of total Hb measured at Visit 1
•9. Patients who, in the judgment of the investigator or the responsible Novartis personnel,
•have a clinically relevant laboratory abnormality or a clinically significant condition such
•as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF),
•uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia,
•hyperadrenergic state or any condition which in the investigat

研究者

发起方

ovartis Health care Private Limited

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