A 52-WEEK TREATMENT, MULTI-CENTER, RANDOMIZED, DOUBLEBLIND,DOUBLE DUMMY, PARALLEL-GROUP, ACTIVE CONTROLLEDSTUDY TO COMPARE THE EFFECT OF QVA149 (INDACATEROL MALEATE/ GLYCOPYRRONIUM BROMIDE) WITH SALMETEROL/FLUTICASONE ONTHE RATE OF EXACERBATIONS IN SUBJECTS WITH MODERATE TO VERYSEVERE COPD

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2014年6月6日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Written informed consent must be obtained before any assessment is performed.
•2. Male or female adults aged ≥40 years.
•3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
•4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears
•are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
•5. Patients with a post-bronchodilator FEV1 ≥25 and < 60% of the predicted normal value,
•and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28).
•(Post refers to 1 h after sequential inhalation of 84 μg (or equivalent dose) of ipratropium
•bromide and 400 μg of salbutamol).
•6. A documented history of at least 1 COPD exacerbation in the previous 12 months that
•required treatment with systemic glucocorticosteroids and/or antibiotics.
•7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101.
•8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).

•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
•hCG (human Chorionic Gonadotropin) laboratory test.
•Women of child-bearing potential, defined as all women physiologically capable of
•becoming pregnant, unless they are using effective methods of contraception during
•dosing of study treatment. Effective contraception methods include.
•Patients with Type I or uncontrolled Type II diabetes.
•4. Patients with a history of long QT syndrome or whose QTc measured at Visit 101
•(Fridericia method) is prolonged (>450 ms for males and females) and confirmed by a
•central assessor. These patients should not be re-screened.
•5. Patients who have a clinically significant ECG abnormality at Visit 101 or Visit 201.
•(These patients should not be re-screened)
•6. Patients who have a clinically significant laboratory abnormality at Visit 101.
•7. Patients who have clinically significant renal, cardiovascular (such as but not limited to
•unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial
•infarction), arrhythmia (see below for patients with atrial fibrillation), neurological,
•endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological
•abnormalities which could interfere with the assessment of the efficacy and safety of the
•study treatment.

发起方

OVARTIS BIOSCIENSES PERU S.A.,