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Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)

NCT04322669 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 338

Last updated 2022-02-02

No results posted yet for this study

Summary

The purpose of this study is to assess the efficacy of pidotimod as treatment in participants with recurrent respiratory tract infections.

Conditions

  • Recurrent Respiratory Tract Infections

Interventions

DRUG

Pidotimod

Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.

DRUG

Placebo

Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.

Sponsors & Collaborators

  • Almirall, S.A.

    lead INDUSTRY

Principal Investigators

  • Study Director · Almirall, S.A.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2021-11-04
Completion
2021-11-04

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04322669 on ClinicalTrials.gov