Randomised Controlled Trial comparing the efficacy of Pidotimod versus placebo in children with persistent asthma.

Not Applicable

Completed

• Conditions: Health Condition 1: null- Children between 5-12years of age with persistent asthma requiring inhaled corticosteroid therapy

• Registration Number: CTRI/2018/04/013405
• Lead Sponsor: Postgraduate Institute Of Medical Education and Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-06-25
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 79

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in PEFR from baseline at the end of 12 weeks of therapy.Timepoint: 4weeks, 8weeks, 12 weeks

Secondary Outcome Measures

Name	Time	Method
Comparison of safety of pidotimod verses placebo at each visit.Comparison of Asthma Symptom Score, FEV1 between the intervention groups at follow up.Comparison of Asthma Symptom Score, FEV1 within each group from baseline to each followup visit.Comparison of PEFR between the intervention groups at 4 weeks and 8 weeks.Comparison of FEV1 between the intervention grooup at follow upTimepoint: 4weeks,8weeks,12weeks