A 52-week treatment, multi-center, randomized, double-blind, parallel-group,active controlled study to evaluate the effect of QVA149 (110/50 microgram o.d.) vs NVA237 (50 microgram o.d.) and open-label tiotropium (18 microgram o.d.) on COPDexacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD)

ovartis Healthcare Pvt Ltd0 个研究点目标入组 2,200 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Male or female adults aged greater than or equal to 40 yrs
•Severe or very COPD [Stage III or IV as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008]
•Smoking history of at least 10 pack years
•Post-bronchodilator FEV1 less than 50 percent of the predicted normal value and post- bronchodilator FEV1 or FVC less than 70percent
•Documented history of at least 1 COPD exacerbation in the previous 12 months that required treatment with systemic glucocorticosteroids and or antibiotics

•Patients requiring long term oxygen therapy (greater than 15 h a day) on a daily basis for chronic hypoxemia
•Patients who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1
•Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
•Patients with concomitant pulmonary disease
•Patients with a history of asthma
•Any patient with lung cancer or a history of lung cancer
•Patients with a history of certain cardiovascular co-morbid conditions
•Other protocol-defined inclusion or exclusion criteria may apply

发起方

ovartis Healthcare Pvt Ltd