Phase 4
N=150
Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children.
Cough · Upper Respiratory Tract Infection
Bottom Line
View on ClinicalTrials.gov: NCT01968434 ↗Enrolled (actual)
150
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcome: Primary: Change in Night Cough Score on First Night of Treatment (From N0 to N1) — -5.16; -1.77 change in combined night cough score — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- protective cough syrup (Device); carbocisteine cough syrup (Drug)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Clalit Health Services
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Night Cough Score on First Night of Treatment (From N0 to N1) |
-5.16; -1.77 | <0.01 sig |
| SECONDARY Change in Night Cough Score at End of Study (From N0 to N4) |
-13.92; -9.48 | <0.01 sig |
| SECONDARY Change in Day Cough Score at End of Study (From D0 to D4) |
-6.17; -4.54 | <0.05 sig |
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
Data sourced from ClinicalTrials.gov (NCT01968434). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.