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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pidotimod | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pidotimod | 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. |
| 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)] |
| 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 |
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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:
Participants compliant with the pidotimod Chinese approved label (package insert) requirements
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Almirall, S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 01 Children's Hospital Captial Institute of Pediatrics | Beijing | 100020 | China | |||
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C064893 | pidotimod |
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| Placebo | 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. |
|
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) |
| 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 |