CTRI/2011/07/001887已完成2 期
A randomized, double-blind, placebo-controlled, Proof of Concept, study of 12 week treatment with RBx 10017609 in subjects with moderate to severe chronic obstructive pulmonary disease (COPD).
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 135
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
- •Inclusion Criteria
- •To be included in this study subjects must satisfy all inclusion and exclusion criteria at Visit 2 and prior to randomization at Visit 3, unless specified otherwise. All relevant medical and non-medical conditions should be taken into consideration when deciding whether this protocol is suitable for a particular subject.
- •1.Subjects who have signed an informed consent consistent with ICH GCP guidelines prior to participation in the trial at prescreening visit.
- •2.Male or female subjects, aged 40 to 75 years (both inclusive). Female subjects should be of non-child bearing potential [post menopausal or those who have undergone surgical sterility (hysterectomy or bilateral tubal ligation or bilateral oophorectomy)].
- •Sexually active male subjects should agree to use a medically accepted form of contraception (barrier method) or must have undergone vasectomy in the past and their partner should be either using a medically acceptable form of contraception (oral contraceptives, intrauterine contraceptive devices) or have undergone tubal ligation in the past.
- •3.Subjects with clinical diagnosis of COPD as defined by Global Initiative for Chronic Obstructive Lung Disease Guidelines, 2009 and who additionally have
- •a.Smoking history of at least 10 pack years (current and former smokers)
- •b.Post bronchodilator FEV1 to FVC ratio of less than 0.70 at screening (Visit 2).
- •c.Post bronchodilator FEV1 of greater than or equal to 30 percent and less than or equal to 70 percent of the predicted normal value at screening.
- •Post bronchodilator refers to within 15 to 30 minutes of inhalation of 4 multiplied by100 mcg of salbutamol delivered at mouth piece (Visit 2).
- •Note: Menopause is defined as the time when there has been no menstrual period for 12 consecutive months and no other biological or physiological cause can be identified (diagnosed on the basis of age appropriateness and history of vasomotor symptoms) or 6 months of spontaneous amenorrhea with FSH levels greater than 40 mIU per mL at screening.
- •Number of pack years that is (number of cigarettes or bidis smoked per day multiplied by number of years smoked) divided by 20.
排除标准
- •Exclusion criteria
- •1.Subjects with history of hypersensitivity to study medication or drugs of similar class or beta 2 agonists or any of the excipients contained in any of these formulations.
- •2.Subjects with Body Mass Index of less than 18 or greater than 35 kg per meter square at screening (Visit 2).
- •3.Pregnant or nursing women or women of child bearing potential.
- •Note: Pregnancy is defined as a state of female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotropin (hCG) laboratory test (greater than 5 mIU per mL).
- •Note: All women who are physiologically capable of becoming pregnant.
- •4.Subjects having alpha 1 antitrypsin deficiency.
- •5.Subjects with history of asthma.
- •Note: History of asthma indicated by, but not limited to: (i) onset of respiratory symptoms suggestive of asthma prior to 40 years of age and (ii) a history of diagnosis of asthma. If the subject had an absolute eosinophil count greater than or equal to 600 per cumm, source documentation is required to verify that the increased eosinophil count is related to a non-asthmatic condition
- •6.Subjects with active pulmonary tuberculosis, lung or any other malignancy, bronchiectasis, cystic fibrosis or pneumonia
- •7.Subjects using inhaled corticosteroids and unable to stop these during the screening/run-in period.
- •8.Subjects who have received treatment with oral or parenteral glucocorticosteroids within 6 weeks of screening or run-in period or depot corticosteroids within 12 weeks of screening/run-in period.
- •9.Subjects with history of COPD exacerbation requiring systemic glucocorticosteroids and/or antibiotics and/or hospitalization within 6 weeks of screening (Visit 2).
- •Note: Once stable, these subjects may be reconsidered for the study.
- •10.Subjects with history of respiratory tract infection within 6 weeks of screening visit (Visit 2).
- •Subjects who develop a respiratory tract infection between pre screening (Visit 1) and randomization (Visit 3) must discontinue from the trial but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met.
- •11.Subjects with hypoxemia (SpO2 less than 88% on room air).
- •12.Subjects with significant disease(s), disorder(s) other than COPD that in the opinion of the Investigator may (i) put the subject at risk because of participation in the study or (ii) interfere with the study evaluations or (iii) cause concern regarding subject?s ability to participate in the study.
- •13.Subjects having arthritis or connective tissue disorder or any other joint disorder that in the opinion of the Investigator might interfere with the study evaluations
- •14.Subjects with history of consistent abnormal fasting blood sugar (greater than 250 mg per dl or 14 mmol per L) or HbA1c greater than 8percent at screening (Visit 2).
- •15.Subjects with family history of long QT syndrome.
- •16.Subjects with clinically significant abnormal 12 lead ECG or QTc greater than 450 milliseconds as calculated by Fridericia formula.
- •17.Subjects with history of any lung surgery (e.g.lung resection etc).
- •18.Subjects with conditions which, in the opinion of the Investigato
研究者
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