CTRI/2015/08/006128已完成3 期
A 12-week treatment, multi-center, randomized, double-blind,double-dummy, parallel group study to assess the efficacy andsafety of switching from salmeterol/fluticasone to QVA149(indacaterol maleate/glycopyrronium bromide) in symptomaticCOPD patients - FLASH
ovartis Healthcare Pvt Ltd0 个研究点目标入组 88 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 88
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. Written informed consent must be obtained before any assessment is performed.
- •2. Male and female >= 40 years
- •3. Current or ex-smokers who have a smoking history of at least 10 pack years (Ten pack
- •years is defined as 20 cigarettes per day for 10 years or 10 cigarettes per day for 20 years).
- •An ex-smoker is defined as a patient who has not smoked for >= 6 months at visit 1.
- •4. Confirmed diagnosis of COPD and post-bronchodilator FEV1 >= 30% and < 80% of the
- •predicted normal value and post-bronchodilator FEV1/FVC < 0.70 at visit 1
- •5. Treated with salmeterol/fluticasone 50/500 μg b.i.d. for at least 3 months prior to visit 1 (Salmeterol/fluticasone 50/500 μg b.i.d. treatment has been decided by the patientâ??s primary physician who has full discretion of the appropriateness of this treatment. This treatment decision has been taken outside the context of study and prior to the patientâ??s consideration for participating in the study)
- •6. Documented CAT score of >= 10 at Visit 1 and 2
排除标准
- •1. Treatment with any LAMA in the 2 weeks prior to visit 1
- •2. Presence of any contraindication, warning, precaution, hypersensitivity in the approved
- •prescribing information for salmeterol/fluticasone
- •3. Prior or current diagnosis of asthma
- •4. History or current diagnosis of clinically significant ECG abnormalities including:
- •a)Concomitant clinically significant cardiac arrhythmias, e.g. sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker
- •b)History of familial long QT syndrome or known family history of Torsades de Pointes
- •5. Resting QTcF (Fridericia preferred) >= 450 msec (male) or >= 460 msec (female) during
- •screening (Visit 1 or 2)
- •6. Concomitant use of medication known to significantly prolong the QT interval unless it
- •can be permanently discontinued for the duration of the study
- •7. Clinically significant co-morbidity that could interfere with the assessment of the safety
- •and efficacy of the study medication
- •8. Paroxysmal (e.g. intermittent) atrial fibrillation; patients with persistent atrial fibrillation
- •as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate
- •control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement,digoxin or ablation therapy), for at least 6 months, may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 1 and 2, with a resting ventricular rate 100/min.
- •9. Contraindications or hypersensitivity to
- •a. Anticholinergic agents
- •b. Long and short-acting β2-agonists
- •c. Sympathomimetic amines
- •d. Lactose or any other excipient of the study medication or to drugs of similar
- •chemical classes
- •10. Any malignancy within the past 5 years except localized basal cell carcinoma of the skin
- •11. Narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck
- •obstruction or moderate to severe renal impairment or urinary retention. Asymptomatic
- •BPH patients are not excluded.
- •12. Not achieved acceptable spirometry results at visit 1 or 2 in accordance with the American
- •Thoracic Society (ATS) or European Respiratory Society (ERS) criteria for acceptability.
- •One retest may be performed for patients not meeting the acceptability criteria.
- •13. More than one COPD exacerbation requiring treatment with antibiotics and/or systemic
- •corticosteroids and/or hospitalization in the year prior to Visit 1
- •14. Patients who developed a COPD exacerbation of any severity within the 6 weeks before
- •the screening (Visit 1) or between screening (Visit 1) and start of treatment (Visit 2) will
- •not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after
- •the resolution of the COPD exacerbation
- •15. Respiratory tract infection within 4 weeks prior to Visit 1
- •16. Respiratory tract infection between Visit 1 and 2. Patients can be re-screened 4 weeks
- •after resolution of the infection
- •17. Requiring oxygen therapy prescribed for 12 hours per day
- •18. Onset of respiratory symptoms, including a COPD diagnosis prior to age 40 years
- •19. Intermittent treatment with a H1-antagonist or intra-nasal corticosteroids for allergic
- •rhinitis (treatment with a stable dose/regimen is perm
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