A multicenter, partially-blinded, randomized, 24-week, parallel-group, non-inferiority, open-label active controlled study to compare the efficacy and safety of QVM149 with a free triple combination of salmeterol/fluticasone + tiotropium in patients with uncontrolled asthma

ovartis Pharma AG0 个研究点目标入组 1,251 人开始时间: 2018年9月20日最近更新: 2019年11月25日

研究概览

暂无简介。

•- Patients with a diagnosis of asthma for a period of at least 6 months prior to Visit 1 with current asthma severity = step 4 (GINA 2017).
•- Patients who have used ICS/LABA combinations for asthma for at least 3 months and at stable medium or high dose of ICS/LABA for at least 1 month prior to Visit 1.
•- Patients must be symptomatic at screening despite treatment with medium or high stable doses of ICS/LABA as defined by ACQ-7 score = 1.5 at visits 101 and 201 (randomization visit).
•- Patients with history of at least one severe asthma exacerbation which required medical care from a physician, ER visit (or local equivalent structure) or hospitalization in the 12 months prior to Visit 1 and required systemic corticosteroid treatment for at least 3 days including physician guided self-management treatment with oral corticosteroids as part of written asthma action plan.
•- Pre-bronchodilator FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators prior to spirometry at both Visit 101 and Visit 201.
•- Patients who demonstrate an increase in FEV1 of = 12% and 200 mL.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 951
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•- Patients who have a smoking history of greater than 20 pack years.
•- Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
•- Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening).
•- Patients treated with a LAMA for asthma within 3 months prior to Visit 1.
•- Patients who have had a respiratory tract infection or clinical significant asthma worsening as defined by Investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 201.

发起方