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Clinical Trials/CTRI/2018/04/013405
CTRI/2018/04/013405
Completed
未知

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

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: null- Children between 5-12years of age with persistent asthma requiring inhaled corticosteroid therapy
Sponsor
Postgraduate Institute Of Medical Education and Research
Enrollment
79
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
June 25, 2019
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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]

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Not specified

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