Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

Study Overview
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Brief Summary
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Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. The intent of this study is to use a protective syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and safety versus placebo in children with moderate to severe night and daily cough. Cough is assessed with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

Detailed Description
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Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Looking into mechanisms for cough management different from mucolytics, or sedatives, such as protection of irritated pharynx mucosa from post nasal drip or other irritating substances is theoretically sound and shows practical interesting results. A parallel comparison of efficacy and tolerability between such protective mechanism (acting through a barrier and radical scavenging action) due to natural substances (honey, plantago lanceolata and thymus vulgaris) and placebo has not been done so far, in very young children, especially in a time frame of 4 days. The intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days. Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy.

Official Title
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Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold

Conditions
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Cough

Intervention / Treatment
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* Device: Cough syrup for adults and children
* Device: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: cough attributed to infection of the upper respiratory tract since less or equal than 7 days, children aged 1 to 5 years score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent, score of at least three of all questions assessing daytime cough considering the day prior to study entry written consent by a parent. Exclusion Criteria: Children with a diagnosis of acute laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies, Children who received antihistamines or any cough medicine the day prior to study entry, The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry, Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus vulgaris, honey or any other component of the cough syrup.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 5 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cough Syrup for adults and children<br>Marked (authorized) medical device acting by protecting the oropharynx, in a non pharmacological way, to reduce cough. It contains honey, plantago lanceolata, thymus vulgaris.Dosage form: syrup Dosage: 5 ml three times a day. Frequency: the duration of the study for each patient is 4 nights, 3 days. | Device: Cough syrup for adults and children<br>* Dosage is 5 ml three times a day for 4 nights, 3 days<br>* Other names: Poliflav M.A.-honey cough syrup;|
| Placebo Comparator: Placebo<br>The placebo intervention is a syrup of same taste and colour without the protective components. Dosage form: syrup. Dosage: 5 ml three times a day Frequency: the duration of the study for each patient is 4 nights, 3 days. | Device: Placebo<br>* Dosage is 5 ml three times a day for 4 nights, 3 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in night cough frequency score in the general population | Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in each morning relating to the passed night for four nights. The basal night score is the score of the night before enrollment. | baseline up to night 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in night cough frequency score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough frequency score in the female population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough frequency score in the male population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough severity score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough severity score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough bothersomeness score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough bothersomeness score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough influence on sleep of child score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough influence on sleep of child score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough influence on sleep of parent score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough influence on sleep of parent score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough combined score in the general population | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in night cough combined score in the population coughing since 1-2 days | All these other elements constitute cough invasiveness into the quality of life of child and parents | baseline up to night 1 | 
| Change in day cough frequency score in the general population | The questionnaire rating day cough is filled in each evening relating to the passed day for three days. The basal day score is the score of the day before enrollment. | baseline up to day 2 |