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

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

Official Title
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Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI), A Randomized, Double Blind, Placebo Controlled Clinical Trial (P-CRESCENT)

Conditions
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Recurrent Respiratory Tract Infections

Intervention / Treatment
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* Drug: Pidotimod
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pidotimod<br> | Drug: Pidotimod<br>* 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.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Respiratory Tract Infection (RI) per Month During Overall Study Period | The mean rate of respiratory infection episodes per month during the overall study period will be analyzed and compared between the reported groups. | Baseline (Day 1) up to end of post-treatment follow-up [Day 180/Early Termination (ET)] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Respiratory Tract Infection (RI) per Month During the Post-treatment Follow-up Period | The mean rate of RI episodes per month during the post-treatment follow-up period will be analyzed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Rate of Respiratory Tract Infection (RI) per Month During the Double-blind Randomized Period | The RI per month during the double-blind randomized treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Days with Respiratory Tract Infections (RI) During the Double-blind Treatment Period | The number of days with RI during the double-blind treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Days with Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period | The number of days with RI during the post-treatment follow-up will be assessed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Days with Respiratory Tract Infections (RI) During the Overall Study Period | The number of days with RI during the overall period will be assessed. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Antibiotic Use Days During the Double-blind Treatment Period | The number of antibiotic use days due to any respiratory infection during the double-blind treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Antibiotic Use Days During the Post-treatment Follow-up Period | The number of antibiotic use days due to any respiratory infection during the post-treatment follow-up period will be assessed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Antibiotic Use Days During the Overall Period | The number of antibiotic use days due to any respiratory infection during the overall period will be assessed. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Antipyretics Use Days During the Double-blind Treatment Period | The number of antipyretics use days during the double-blind treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Antipyretics Use Days During the Post-Treatment Follow-up Period | The number of antipyretics use days due to any respiratory infection during the post-treatment follow-up period will be assessed. The number of antipyretics use days during the double-blind 60-day treatment period will be assessed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Antipyretics Use Days During the Overall Period | The number of antipyretics use days due to any respiratory infection during the overall period will be assessed. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Percentage of Participants Free of Respiratory Tract Infections (RI) During the Double-blind Treatment Period | The percentage of participants free of RI during the double-blind treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Percentage of Participants Free of Respiratory Tract Infections (RI) During the Post-treatment Follow-up Period | The percentage of participants free of RI during the post-treatment follow-up period will be assessed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Percentage of Participants Free of Respiratory Tract Infections (RI) During the Overall Period | The percentage of participants free of RI during the overall period will be assessed. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Hospitalization Days During the Double-blind Treatment Period | The number of hospitalization days due to any respiratory infection during the double-blind treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Hospitalization Days During the Post-treatment Follow-up Period | The number of hospitalization days due to any respiratory infections during the post-treatment follow-up period will be assessed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Hospitalization Days During the Overall Period | The number of hospitalization days due to any respiratory infections during the overall period will be assessed. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Percentage of Participants with At Least One Hospitalization During the Double-blind Treatment Period | The percentage of participants with at least one hospitalization due to any respiratory infections during the double-blind treatment period will be assessed. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Percentage of Participants with At Least One Hospitalization During the Post-treatment Follow-Up Period | The percentage of participants with at least one hospitalization due to any respiratory infections during the post-treatment follow-up period will be assessed. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Percentage of Participants with At Least One Hospitalization During the Overall Period | The percentage of participants with at least one hospitalization due to any respiratory infections during the overall period will be assessed. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Wheezing Attack Days During the Double-blind Treatment Period | The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the double-blind treatment period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Wheezing Attack Days During the Post-treatment Follow-up Period | The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the post-treatment follow-up period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Wheezing Attack Days During the Overall Period | The number of wheezing attack days will be observed in terms of two responses: Yes or No, during the during the overall period. An acute wheezing attack is defined as an episode of progressively increasing shortness of breath, cough, wheezing, chest retraction or tightness, or any combination of these symptoms that lasted at least 6 hours with normal results on chest radiographic examinations. In participants with repeated symptoms, attacks are counted separately only if the participant had been without symptoms for at least 1 week between the end of one episode and the beginning of another. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Asthma Days During the Double-blind Treatment Period | The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the double-blind treatment period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Asthma Days During the Post-treatment Follow-up Period | The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the post-treatment follow-up period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Asthma Days During the Overall Period | The number of days of asthma attacks will be observed in terms of two responses: Yes or No, recorded in the e-diary, during the overall period. Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation and airway hyperresponsiveness with main clinical manifestations of recurrent wheezing, cough, shortness of breath and chest tightness. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Participants with Adverse Events (AE) During the Double-blind Treatment Period | An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the double-blind treatment. | Baseline (Day 1) up to end of double-blind treatment (Day 60) | 
| Number of Participants with Adverse Events (AE) During the Post-treatment Follow-up Period | An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the post-treatment follow- up. | From end of double-blind treatment (Day 60) up to end of post-treatment follow-up (Day 180/ET) | 
| Number of Participants with Adverse Events (AE) During the Overall Period | An AE is defined as any unfavorable and unintended sign (including a clinically significant abnormal laboratory finding), symptom or disease, temporally associated with the use of a medicinal product, regardless of its nature, intensity, seriousness, or presumed relationship (causality) to the product or experimental procedure used. Participants who experienced any AE will be assessed during the overall study. | Baseline (Day 1) up to end of post-treatment follow-up (Day 180/ET) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatrics Study, Recurrent Respiratory Tract Infections, Pidotimod