Clinical trial NCT03218696: 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
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cough
Acute Upper Respiratory Tract Infection
Keywords: cough
children
Acute Upper Respiratory Tract Infection
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Aboca Spa Societa' Agricola
First posted: 2017-07-14
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel randomized double blind
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Cough attributed to infection of the upper respiratory tract present in the child for not more than 2 days.
2. Children aged 1 year to 5 (ie: 1 day before the 6th birthday, males and females)
3. 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,
4. Score of at least 3 to all three questions assessing "daytime" cough considering the day prior to study entry.
5. 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.

  2. Children who received antihistamines or any cough medicine the day prior to study entry.

  3. The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry.

  4. 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".

Primary outcomes:
measure: Night cough frequency score reduction
timeFrame: First and only night of treatment
Secondary outcomes:
measure: night cough intensity score reduction
timeFrame: First and only night of treatment
measure: night cough bothersomeness score reduction
timeFrame: First and only night of treatment
measure: reduction of influence of cough on child sleep score
timeFrame: First and only night of treatment
measure: reduction of influence of cough on parent sleep score
timeFrame: First and only night of treatment
measure: reduction of influence of cough on combined night score
timeFrame: First and only night of treatment
Other outcomes:
Locations:
city: Petaẖ Tiqwa
country: Israel
facility: Pediatric Community Ambulatory Clinic - Petach-Tikva
city: Petaẖ Tiqwa
country: Israel
facility: Pediatric Community Ambulatory Clinic
Study officials:
affiliation: Clalit Health Services
name: Herman A Cohen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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