Comparison of Efficacy and Tolerability of Two Cough Syrups in Cough Due to Cold in Children. (URTI)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by Clalit Health Services
Sponsor:
Information provided by (Responsible Party):
Avner Herman Cohen, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01968434
First received: October 17, 2013
Last updated: October 19, 2013
Last verified: October 2013
  Purpose

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 carbocisteine syrup usually used to treat children (Syr Mucolyt).


Condition Intervention Phase
Cough
Upper Respiratory Tract Infection
Device: protective cough syrup
Drug: carbocisteine cough syrup
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Clalit Health Services:

Primary Outcome Measures:
  • reduction in night cough severity [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    Night cough severity is most bothersome to the child and family. The questionnaire rating night cough is filled in each morning relating to the passed night for four nights. The basal night score is the score of the night before enrollment.


Secondary Outcome Measures:
  • reduction in day cough severity [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    The questionnaire rating day cough is filled in each evening relating to the passed day for three days. The basal day score is the score of the day before enrollment.


Estimated Enrollment: 150
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: protective cough syrup

syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.

Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)

Device: protective cough syrup
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.
Other Name: Grintuss
Active Comparator: carbocisteine cough syrup
Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)
Drug: carbocisteine cough syrup
Mucolytic
Other Names:
  • Mucolyt
  • Lisomucil

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 carbocisteine 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

Ages Eligible for Study:   2 Years to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 carbocisteine specifically to the comparator Mucolyt
  • gastric ulcer
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01968434

Contacts
Contact: Herman Avner Cohen, Professor + 972-3- 9398203 hermanc@clalit.org.il
Contact: Yifat Atias, Dr + 972-3- 9398200 ifatat@clalit.org.il

Locations
Israel
Pediatric Community Ambulatory Clinic - Petach-Tikva Not yet recruiting
Petach-Tikva, Israel
Contact: Herman Av Cohen, Professor    00 972-3- 9398203    hermanc@clalit.org.il   
Contact: Yifat Atias, Dr.    + 972-3- 9398200    ifatat@clalit.org.il   
Principal Investigator: Herman Av Cohen, Professor         
Sub-Investigator: Katyusha Karnolska, Dr.         
Sub-Investigator: Ruth Shenhav, Dr.         
Sub-Investigator: Monica Finkelstein, Dr.         
Sub-Investigator: Michael Israel, Dr.         
Sub-Investigator: Yifat Attias, Dr.         
Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Herman Avner Cohen, Professor Clalit Health Services
  More Information

Publications:

Responsible Party: Avner Herman Cohen, MD. Head Dep. Pediatric Ambulatory Clinic -Petah-Tikva, Israel, Clalit Health Services
ClinicalTrials.gov Identifier: NCT01968434     History of Changes
Other Study ID Numbers: COM-13-00
Study First Received: October 17, 2013
Last Updated: October 19, 2013
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research
Israel: Ministry of Health

Keywords provided by Clalit Health Services:
cough
common cold
antitussive agents
mucosal protection
medical device

Additional relevant MeSH terms:
Cough
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Carbocysteine
Anti-Infective Agents, Local
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on September 16, 2014