Prospective, open label, multicentre, single arm, Phase IV post marketing study for evaluation of safety and effectiveness of Indacaterol/Glycopyrronium/Mometasone (FDC) DPI in asthmatic patients - NI

upin Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

暂无简介。

•i. Patients aged between 18 - 65 years (both inclusive) of either gender diagnosed with bronchial
•asthma and eligible to receive Indacaterol/Glycopyrronium/Mometasone (FDC) DPI
•ii. Reversibility FEV1 of at least 12% and 200 mL
•iii. Pre-bronchodilator FEV1 of 40-90% predicted normal
•iv. Currently using ICS ± SABA/LABA, for at least 4 weeks prior to 1st visit.
•v. Patient willing to give a written informed consent

•I. Refusal to participation expressed by patient.
•II. History of life-threatening asthma or more than four separate exacerbations or more than two
•hospitalizations for asthma in the previous year.
•III. Smoking history of more than 10 pack-years
•IV. Pregnant or lactating women.
•V. Patients who have participated in any clinical trial within 30 days prior to enrolment and would not
•be participating in clinical study during the period of study participation.
•VI. History of known hypersensitivity to any individual study drug of the study drug combination or to
•any of the excipient present in the dosage form

发起方

upin Limited