A Randomized, Multi-center, Parallel Group, Double Blind, Study to Assess the Safety of QMF Twisthaler® (500/400 µg) and Mometasone Furoate Twisthaler® (400 µg) in Adolescent and Adult Patients With Persistent Asthma

ovartis HealthCare Pvt Ltd0 个研究点目标入组 1,500 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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•Patients with a documented diagnosis of persistent asthma (according to GINA guidelines) for a period of at least 6 months prior to Visit 1 and who are currently treated with or qualify for treatment (according to asthma treatment guidelines) with both ICS and LABA combination. They must have used ICS as part of their asthma regimen for at least 2 months prior to Visit 1.
•Patients demonstrating an increase in FEV1 of ≥12% or ≥200 mLs within 30 minutes after administration of β2-agonist (SABA) as per site protocol. Alternatively, patients may have documentation of reversibility within the last 12 months.
•Patients with an FEV1 ≥50% of predicted normal at Visit 2. This criterion for FEV1 will have to be demonstrated after all restricted medications have been withheld for appropriate intervals (washout period of at least 6 hours for a short acting β2-agonist and a minimum of 24 hours for a long acting β2-agonist).

•Patients with a previous diagnosis of COPD
•Patients who have had an asthma attack/exacerbation requiring hospitalization within 1 month prior to visit 3.
•Patients who have had an emergency room visit asthma attack/exacerbation within 1 month prior to visit 3.
•4. Patients who have ever required ventilator support for respiratory failure secondary to asthma
•5. Patients with diabetes Type I or uncontrolled (in the judgement of the investigator) diabetes Type II
•6. Patients with concomitant pulmonary disease
•7. Patients with certain cardiovascular co-morbid conditions
•7. Patients with any significant medical condition that might compromise patient safety, interfere with evaluation or preclude completion of the study

发起方

ovartis HealthCare Pvt Ltd