Clinical trial NCT01968434: Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.
Official title: Randomized, Single Blind, Multicenter Study to Evaluate the Efficacy and Tolerability of Syr. Grintuss Pediatric and Syr. Mucolit in Cough Due to Upper Respiratory Tract Infection in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cough
Upper Respiratory Tract Infection
Keywords: cough
common cold
antitussive agents
mucosal protection
medical device
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
Collaborators: name: Aboca Spa Societa' Agricola
First posted: 2013-10-24
Enrollment: 150
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if there is comparable efficacy between carbocisteine and a protective cough syrup from natural ingredients in children's cough due to upper respiratory tract infections (URTI) such as the common cold. The hypothesis is that protecting the throat is very useful in decreasing cough severity, both day and night, without needing to subdue such an important reflex as cough, and without only acting on mucous fluidification, especially in children where sedation and excessive fluidification is dangerous. The research hypothesis is that the protective (Grintuss) Syrup relieves cough (frequency, intensity, degree of disturbance due to nocturnal cough, and improves the quality of sleep of the child) as much as or more than the carbocysteine syrup usually used to treat children (Syr Mucolit).

Detailed description: Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Mucolytic agents have been shown to be helpful but side effects have been reported and use has been prohibited under 2 years of age. Therefore, a completely safe and effective cough remedy has not been officially reported yet in a randomised trial. Looking into other mechanisms for cough management 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, grindelia robusta and helichrysum italicum) and a mucolytic substance has not been done so far, in young children, especially in a time frame of 4 days. The intent of this study is to use the protective syrup versus carbocysteine in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. The invasiveness of cough is followed immediately after one night administration of the study products and daily for four days.

A similar effectiveness of the protective cough syrup as compared to carbocisteine is considered very interesting due to the mechanism of the remedy.

Eligibility criteria: Inclusion Criteria:

* cough attributed to URTI such as the common cold
* 2-5 years of age
* moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment.
* moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough (frequency of nocturnal cough, impact of the sleep of the child and impact on the sleep of the parent)
* signature of informed consent

Exclusion Criteria:

* Children with the diagnosis of diseases of the lower respiratory tract: inflammation of the larynx, trachea, bronchi, pneumonia, asthma, sinusitis, allergic rhinitis, as well as heart disease.
* Children who received cough medicines or drugs containing antihistamines the day prior to study entry.
* Known hypersensitivity to honey or any other component of the experimental product such as Grindelia, Helichrysum, essential oils natural flavourings of Lemon, Sweet Orange, Myrtle; Lemon natural flavouring
* Children who received any steroid preparation (spray nozzle , or syrup , or other similar the day before study entry )
* Known sensitivity to carbocysteine specifically to the comparator Mucolit
* gastric ulcer

Primary outcomes:
measure: Change in Night Cough Score on First Night of Treatment (From N0 to N1)
timeFrame: 1 night from before enrollment (N0) to first night after treatment (N1)
Secondary outcomes:
measure: Change in Night Cough Score at End of Study (From N0 to N4)
timeFrame: 4 nights (onset of trial Night 1 to Night 4) and 3 days
measure: Change in Day Cough Score at End of Study (From D0 to D4)
timeFrame: 4 nights (onset of trial Night 1 to Night 4) and 3 days
Other outcomes:
Locations:
city: Bat Yam
country: Israel
facility: Pediatric Ambulatory Clinic Bat-Yam
city: Kfar Saba
country: Israel
facility: Pediatric Ambulatory Clinic Kfar-Saba
city: Petaẖ Tiqwa
country: Israel
facility: Pediatric Community Ambulatory Clinic - Petach-Tikva
city: Tel Aviv
country: Israel
facility: Pediatric Ambulatory Clinic Ramat Aviv Gimel
Study officials:
affiliation: Clalit Health Services
name: Herman Avner Cohen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6.
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