Randomised Controlled Trial Comparing efficacy of Pidotimod versus placebo in addition to inhaled corticosteroid therapy in children with persistent asthma. - PIDO

Postgraduate Institute Of Medical Education and Research0 个研究点目标入组 79 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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•Newly diagnosed children (5-12 years old) with persistent asthma defined as per Global Initiative for Asthma guideline [ diagnosis is made in children with history of variable respiratory symptoms i.e, wheeze, cough, shortness of breath, chest tightness atleast >twice/week symptoms, >3-4/month nocturnal symptoms, frequent ER visits for asthma and documented expiratory airflow limitation i.e. FEV1 or PEFR <80% of predicted, FEV1/FVC <80% and PEFR variability >20 which improve upon bronchodilator challenge after adequately ruling out acute and chronic conditions that mimic asthma]

•1. Children who have received asthma preventer therapy (i.e. inhaled corticosteroids or any preventer therapy), for any duration >2 weeks, during the preceding six months.
•2. Children suffering from other diseases that can cause wheezing or difficulty breathing viz cystic fibrosis, and chronic lung disease.
•3. Children with congenital lung dysplasia;
•4. Children with previously diagnosed severe renal failure.
•5. Children with autoimmune, or immunodeficiency disorders.
•6. Children who have been prescribed any immunomodulator therapy for any condition in the past.
•7. Children whose parents are unwilling or unable to adhere to the follow up protocol.

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