Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold

Sponsor

Clalit Health Services (Other)

Overall Status

Unknown status

CT.gov ID

NCT03218696

Collaborator

Aboca Spa Societa' Agricola (Industry)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The intent of this study is to see how boys and girls aged 1-5 and coughing since 1-2 days due to common cold respond to a specific protective cough syrup taken before going to bed for one night, with respect to a similar but not specific syrup (placebo). The symptoms evaluated include especially cough frequency but also cough intensity, bother, and sleep quality of the child and parents.

Condition or Disease	Intervention/Treatment	Phase
Cough Acute Upper Respiratory Tract Infection	Device: Cough Syrup for adults and children Device: Placebo	N/A

Detailed Description

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 been looked at specifically on the clinically critical population of children coughing since 1-2 days and not more, including very young children of one year old. 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. Daily cough is assessed to better describe and select the general condition of the child however only night cough parameters due to treatment are assessed. The degree of disturbance of cough is followed immediately after one night administration on all night parameters, with special interest to frequency.

Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy. The study looks at the effect of the syrup/placebo on the first night in order to well focus the "first" effect of a treatment on the ascending phase of the illness, such as to reduce to a minimum any interference due to natural regression of the symptom due to illness progression.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel randomized double blindParallel randomized double blind

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

According to a predertermined list, the two products are provided in identical bottles and cartons appropriately labelled so as to ensure respect of the randomization list as well as blinding of all study participants.

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-blind Study to Evaluate the Efficacy and Tolerability of a Cough Syrup Containing Specific Plant Extracts (Poliflav M.A.) and Honey Versus Placebo in Cough Due to Upper Respiratory Tract Infection

Anticipated Study Start Date :

Feb 1, 2018

Anticipated Primary Completion Date :

Sep 1, 2018

Anticipated Study Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cough Syrup for adults and children CE 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. Duration: one night	Device: Cough Syrup for adults and children The intervention product is a medical device in Europe due to its non-pharmacological mode of action, which makes the product compliant to the medical device definition. It is made of specific extracts of plants (plantago and thymus) which provide the product with protective characteristics of the oropharynx. These protective features enable the syrup to reduce the irritative cough promoting stimuli on the throat, which decrease urge to cough threshhold. In addition to these extract, honey completes the formula. The product does not contain any artificial component and no preservatives. Other Names: Poliflav M.A.-honey cough syrup
Placebo Comparator: Placebo The placebo intervention is a similar syrup of taste and colour, with general protective components and other necessary synthetic components which may have an influence on cough, without the specific natural protective components. Dosage form: syrup. Dosage: 5 ml. Duration: one night	Device: Placebo The placebo intervention is a syrup of same taste and colour without the natural protective components but with the necessary synthetic preservatives and other co-sweeteners to guarantee quality and safety. The placebo has, in fact, all the features of a cough syrup since true placebo syrup is not possible in cough. The lack of specific natural protective components is weighed against the presence of other necessary substances which may still have an effect on cough, but this effect is not envisaged to be a specific protective effect.

Arm

Intervention/Treatment

Experimental: Cough Syrup for adults and children

CE 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. Duration: one night

Device: Cough Syrup for adults and children

The intervention product is a medical device in Europe due to its non-pharmacological mode of action, which makes the product compliant to the medical device definition. It is made of specific extracts of plants (plantago and thymus) which provide the product with protective characteristics of the oropharynx. These protective features enable the syrup to reduce the irritative cough promoting stimuli on the throat, which decrease urge to cough threshhold. In addition to these extract, honey completes the formula. The product does not contain any artificial component and no preservatives.

Other Names:

Poliflav M.A.-honey cough syrup

Placebo Comparator: Placebo

The placebo intervention is a similar syrup of taste and colour, with general protective components and other necessary synthetic components which may have an influence on cough, without the specific natural protective components. Dosage form: syrup. Dosage: 5 ml. Duration: one night

Device: Placebo

The placebo intervention is a syrup of same taste and colour without the natural protective components but with the necessary synthetic preservatives and other co-sweeteners to guarantee quality and safety. The placebo has, in fact, all the features of a cough syrup since true placebo syrup is not possible in cough. The lack of specific natural protective components is weighed against the presence of other necessary substances which may still have an effect on cough, but this effect is not envisaged to be a specific protective effect.

Outcome Measures

Primary Outcome Measures

Night cough frequency score reduction [First and only night of treatment]
Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in the morning following enrollment, relating to the passed night. The basal night score is the score of the night before enrollment.

Secondary Outcome Measures

night cough intensity score reduction [First and only night of treatment]
All these other elements constitute cough invasiveness into the quality of life of child and parents
night cough bothersomeness score reduction [First and only night of treatment]
All these other elements constitute cough invasiveness into the quality of life of child and parents
reduction of influence of cough on child sleep score [First and only night of treatment]
All these other elements constitute cough invasiveness into the quality of life of child and parents
reduction of influence of cough on parent sleep score [First and only night of treatment]
All these other elements constitute cough invasiveness into the quality of life of child and parents
reduction of influence of cough on combined night score [First and only night of treatment]
All these other elements constitute cough invasiveness into the quality of life of child and parents

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 5 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Cough attributed to infection of the upper respiratory tract present in the child for not more than 2 days.
Children aged 1 year to 5 (ie: 1 day before the 6th birthday, males and females)
Score of at least 3 to two of the following three questions relating to the evaluation of night cough: frequency of nocturnal cough, impact on the sleep of the child and impact on the sleep of the parent,
Score of at least 3 to all three questions assessing "daytime" cough considering the day prior to study entry.
Written signed consent by a parent.

Exclusion Criteria:

1. 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 "Poliflav M.A.-honey cough syrup".