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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avner Herman Cohen, Clalit Health Services
ClinicalTrials.gov Identifier:
NCT01968434
First received: October 17, 2013
Last updated: October 5, 2015
Last verified: October 2015
  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:
  • Change in Night Cough Score on First Night of Treatment (From N0 to N1) [ Time Frame: 1 night from before enrollement (N0) to first night after treatment (N1) ] [ Designated as safety issue: No ]
    Night cough is most bothersome to the child and family. Cough was measured with a validated questionnaire which asks parents to rate 5 aspects of night cough: frequency, severity, bothersomeness, child sleep and parent sleep according to a 7 point Likert scale, from 0 (not at all) to 6 (extremely). Lower scores indicate a better condition. The morning after the first night of treatment (N1) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The sum of scores for all 5 aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as "change in combined night cough score" and it refers to the change from N0 to N1. Negative values of the change indicate an improvement in the condition of the patient.


Secondary Outcome Measures:
  • Change in Night Cough Score at End of Study (From N0 to N4) [ Time Frame: 4 nights (onset of trial Night 1 to Night 4) and 3 days ] [ Designated as safety issue: No ]
    A validated cough questionnaire measuring 5 aspects of night cough (frequency, severity, bothersomeness, child sleep and parents' sleep) on a 7 point Likert scale was used each morning to rate the passed night. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every night of the trial is rated. The morning after the last night of the study (N4) the parents rated the passed night by scoring from 0-6 each of the 5 aspects of night cough. The summed score for all aspects gives the combined night cough score. This score, ranging between 0-30, was subtracted from the sum of all aspects, also ranging between 0-30, form the basal night cough score of the night before enrollment (N0). This change is recorded as "change in combined night cough score" and it refers to the change from N0 to N4. Negative values of the change indicate an improvement in the condition of the patient.

  • Change in Day Cough Score at End of Study (From D0 to D4) [ Time Frame: 4 nights (onset of trial Night 1 to Night 4) and 3 days ] [ Designated as safety issue: No ]
    A validated cough questionnaire measuring 3 aspects of daytime cough (frequency, severity, bothersomeness) on a 7 point Likert scale was used each evening to rate the passed day, as regards these aspects. The scale rates each parameter from 0 (not at all) to 6 (extremely). Every day of the trial is rated. The last evening of the study (D4) the parents rated the passed day by scoring from 0-6 each of the 3 aspects of day cough. The summed score for all aspects gives the combined day cough score. This score, ranging between 0-18, was subtracted from the sum of all aspects, also ranging between 0-18, form the basal day cough score of the day before enrollment (D0). This change is recorded as "change in combined day cough score" and it refers to the change from D0 to D4. Negative values of the change indicate an improvement in the condition of the patient.


Enrollment: 150
Study Start Date: December 2013
Study Completion Date: April 2014
Primary Completion Date: March 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: 20 ml divided in three doses per 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   (Child)
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

Locations
Israel
Pediatric Community Ambulatory Clinic - Petach-Tikva
Petach-Tikva, Israel
Sponsors and Collaborators
Clalit Health Services
Investigators
Principal Investigator: Herman Avner Cohen, Professor Clalit Health Services
  More Information

Publications:
Department of child and adolescent health. Cough and cold remedies for the treatment of acute respiratory infections in young children. Geneva, Switzerland: World Health Organization: 2001.
Kraft K. Efficacy of fluid in Plantago lanceolata extract (PLFE) in acute respiratory disease. Phytomedicine, Supplement 1, 1996

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
Results First Received: May 14, 2015
Last Updated: October 5, 2015
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:
Infection
Cough
Respiratory Tract Infections
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Carbocysteine
Anti-Infective Agents, Local
Anti-Infective Agents
Expectorants
Respiratory System Agents

ClinicalTrials.gov processed this record on August 25, 2016