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

Clalit Health Services

Status: Completed

Conditions: Cough

Treatments: Device: Cough syrup for adults and children; Device: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02486835

ABO-cough-2015

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 150 patients

Sex: All

Ages: 1 to 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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150 participants in 2 patient groups, including a placebo group

"Cough Syrup for adults and children"

Experimental group

Description:

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.

Treatment:

Device: Cough syrup for adults and children

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Device: Placebo