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 afree triple combination of salmeterol/fluticasone plustiotropium in patients with uncontrolled asthma - Argon

ovartis Healthcare Private Limited0 个研究点目标入组 71 人开始时间: 待定最近更新: 2021年11月24日

研究概览

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•1 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).
•2 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.
•3 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).
•4 Patients with history of at least one severe asthma exacerbation (see section 6.4.5) 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.
•5 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.
•6 Patients who demonstrate an increase in FEV1 of >= 12% and 200 mL 15 to 30 minutes after administration of 400microgram salbutamol or 360 microgram albuterol through a spacer device at visit 101

•1 Patients who have a smoking history of greater than 20 pack years.
•2 Patients diagnosed with Chronic Obstructive Pulmonary Disease (COPD).
•3 Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening).
•4 Patients who have ever required intubation for a severe asthma attack or exacerbation.
•5 Patients treated with a LAMA for asthma within 3 months prior to Visit 1.
•6 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.
•7 Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g Glaucoma, cataract and fragility fractures) who are according to Investigators medical judgment at risk participating in study.

发起方

ovartis Healthcare Private Limited