Efficacy and safety of fixed dose combinations of Indacaterol/Glycopyrronium versus Formoterol/Tiotropium in patient with mild to moderate COPD: a randomised open label study

PGIMS Rohtak0 个研究点目标入组 0 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.Both male and female adults aged 40 years and abovewith clinical diagnosis of mild to moderate COPD according to GOLD Criteria.
•2.Confirmed post-bronchodilator spirometry criteria of FEV1 50-70%and FEV1/FVC <0.70 of the predicted normal.
•3. All patients will be needed to be symptomatic for inclusion, classified as CAT total score <= 20 at screening.
•4.Smokers with a smoking history of at least 10 pack years.
•5.Stable and symptomatic, fresh and old cases will be taken.
•6.Patient who will agree to sign written informed consent prior to participation.
•7.Patient who will accept to comply with the requirements of the protocol.

•1.Patient suffering from asthma, allergic rhinitis.
•2.COPD exacerbations 4 weeks before screening.
•3.Other Cardiovascular conditions like myocardial infarction, heart failure, severe cardiac arrhythmia requiring treatment within last 6 weeks.
•4.Patient with lung cancer, active tuberculosis, interstitial lung disease.
•5.Patient with narrow angle glaucoma requiring drug therapy.
•6.Known symptomatic prostatic hypertrophy requiring drug therapy or operation.
•7.Women who are pregnant and nursing.
•8.Patients suffering with liver or renal dysfunction.
•9.Prior hospitalization in last one month that required treatment with antibiotics and corticosteroids.
•10.Patients with a current or recent (within the past 4 weeks) acute serious illness, acute psychiatric illness.
•11.Any history of allergy to study medication.
•12.Patients vaccinated with live attenuated vaccines within 2 weeks prior to screening visit or during run-in period.
•13.Patient who use oxygen therapy.

发起方

PGIMS Rohtak