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

NCT ID: NCT04322669

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 338 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-04
• Study Completion Date: 2021-11-04

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Pidotimod

Group Type: EXPERIMENTAL

Pidotimod

Intervention Type: DRUG

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.

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participants having the study informed consent signed by their parent(s) / guardian. Participants will also assent specifically for their study participation signing an independent assent form. Site specific ethics requirements will be followed
• Participants with history of respiratory tract infections (Chinese Clinical Concept and management of recurrent respiratory tract infections in children [revised] (2008) (Zhonghua er ke za zhi = Chinese journal of Pediatrics; 46 (2): 108-10) of either:

• at least the following episodes of upper respiratory tract infections (ear/nose/throat) in the last year: 6 for those aged 3-5 years old at inclusion; 5 for those aged 6-14 years old at inclusion
• OR at least 2 episodes of lower respiratory tract infections (trachea/bronchia/lungs) in the last 12 months
• Participants compliant with the pidotimod Chinese approved label (package insert) requirements

Exclusion Criteria

• Participants with any immunodeficiency condition, either primary or secondary (including Acquired immunodeficiency syndrome [AIDS], cancers of the immune system, immune-complex disease, chemotherapy, and radiation)
• Participants with known allergies or hypersensitivity to pidotimod or any of its excipients. Antibiotics allergic participant will not be excluded; but due warning will be given
• Participants with immunomodulatory treatment washout period of less than 4 weeks up to baseline visit
• Participants with any concomitant severe disease at the time of screening that are judged by the investigator that could be detrimental to the participant or could compromise the study (e.g. congenital heart disease, Rheumatic immune disease, congenital deformity of trachea, chronic pulmonary disease, chronic liver and kidney disease, etc)
• Female pregnant or of child bearing potential, for whom the investigator suspects might maintain sexual intercourse, unless she has a negative blood pregnancy test at screening and agrees to use two methods of contraception during the study
• Participants who has previously completed or withdrawn from this study
• Participants with evidence of significant active neuropsychiatric disease, alcohol abuse or drug abuse, in the investigator's opinion
• Participants currently enrolled in, or discontinued within the last 30 days prior to baseline from a clinical study involving an off-label/new use of an investigational drug or device, or concurrently enrolled in a non-observational clinical study or any other type of medical research judged not to be scientifically or medically compatible with this study
• Participants who is unreliable and unwilling to make him/herself available for the duration of the study and who will not abide by the research unit policy and procedure and study restrictions
• Parents/Caregivers without cell phone, tablet or computer availability

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Almirall, S.A.

Locations

Investigator Site 01 Children's Hospital Captial Institute of Pediatrics

Beijing, , China

Investigator Site 16

Changchun, , China

Investigator Site 09

Changde, , China

Investigator Site 12

Changsha, , China

Investigator Site 07

Guangzhou, , China

Investigator Site 10

Guilin, , China

Investigator Site 14

Kunming, , China

Investigator Site 03

Nanjing, , China

Investigator Site 11

Sanya, , China

Investigator Site 02

Shanghai, , China

Investigator Site 06

Shantou, , China

Investigator Site 13

Shaoyang, , China

Investigator Site 05

Tianjin, , China

Investigator Site 04

Xiamen, , China

Investigator Site 08

Yanji, , China

Investigator Site 15

Zhengzhou, , China

Countries

China

Other Identifiers

M-PIMOT-40

Identifier Type: -

Identifier Source: org_study_id