Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough

Study Overview
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Brief Summary
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The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.

Detailed Description
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Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.

Official Title
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Randomized, Single-center, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Tolerability of ABO/MEG-B-09 in Pediatric Cough

Conditions
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Cough

Intervention / Treatment
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* Device: AboMeg-B-09
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged between 3 and 6 Acute cough - lasting 1-3 weeks Written informed consent by the parents/legal tutors Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study Parents/legal tutors must be willing to comply with the study protocol Exclusion Criteria: Children treated with immunostimulators and immune regulating drugs during the last month before starting the study Children with immunodeficiencies or immune suppression Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases Children treated with antibiotics, including prophylactic treatment Children being treated with systemic corticosteroids - including oral aerosol inhaler Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month Children who have participated in previous studies with experimental products within the last month Children with asthma or suspected diagnosis of asthma Children with bacterial diseases - Pneumonia, Sepsis Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo Children allergic to any study product ingredients Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 6 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: AboMeg-B-09 syrup<br>Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period | Device: AboMeg-B-09<br>* Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period<br>|
| Placebo Comparator: Placebo<br>Placebo syrup | Other: Placebo<br>* Placebo syrup: 5ml to be taken 4 times a day during the entire study period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough score variation | Clinical diurnal and nocturnal cough score (Chung) | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough reflex sensitivity | Capsaicin test - Cough Reflex Index (CRI) - | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | 
| Objective breath sounds | Wheezometer test | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | 
| The ventilation of the various pulmonary zones | Vibration Response Imaging (VRI) xp test | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | 
| Quality of life | Quality of life questionnaire (QoL) | Measured at Baseline Visit (day 0) and at the Last Visit (day 8) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pediatric, children, acute cough, treatment, syrup, protective natural extracts