An open label, comparative, multicentric study to assess the efficacy and safety of fixed dose combination of Formoterol fumarate & Mometasone furoate Dry Powder Inhaler DPI and fixed-dose combination of Formoterol fumarate & Budesonide Dry Powder Inhaler (DPI) for the treatment of bronchial asthma and or COPD.

Cadila Healthcare Ltd0 个研究点目标入组 200 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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•1.Patients between 18-65 years of age
•2.Patients with an established diagnosis of bronchial asthma and/or chronic obstructive pulmonary disease (COPD) requiring a combination of long acting beta 2-agonists and inhalation corticosteroids
•3.Informed consent of the patient/relative

•1.Pregnancy and/or lactation
•2.Patients with severe or recently unstable bronchial asthma or status asthmaticus
•3.Patients requiring nebulized therapy or oral corticosteroids
•4.Patients with active or quiescent tuberculosis infection, glaucoma, untreated systemic fungal, bacterial, viral or parasitic infections or ocular herpes simplex
•5.Patients with a clinically relevant respiratory tract infection in the four weeks prior to enrolment
•6.Patients with any significant disease of any other organ system (renal, hepatic, cardiovascular, neurologic etc.) that could interfere with the study or require treatment which might interfere with the study
•7.Patients with history of known hypersensitivity to formoterol fumarate or mometasone furoate or budesonide or salbutamol or any component of the formulations
•8.Patients with any other serious concurrent illness or malignancy
•9.Patients with continuing history of alcohol and/or drug abuse
•10.Participation in another clinical trial in the past 3 months

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