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
Intervention: protective cough syrup; carbocisteine cough syrup
Intervention description: 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
Intervention MeSH terms: Carbocysteine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 150.0
Sex: All
Minimum age: 2 Years
Maximum age: 5 Years
Healthy volunteers: No
Keywords: cough; common cold; antitussive agents; mucosal protection; medical device

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).
    

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