Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.
Condition: Cough; Upper Respiratory Tract Infection
MeSH terms: Infections; Respiratory Tract Infections; Cough
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): protective cough syrup; carbocisteine cough syrup
Intervention type(s): Device; Drug
Intervention description(s): The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.; Mucolytic
Other intervention name(s): Grintuss; Mucolit; Lisomucil
Intervention MeSH terms: Carbocysteine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cough; common cold; antitussive agents; mucosal protection; medical device