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

NCT01968434 | Completed Phase 4 Results

• 1 other identifier: COM-13-00
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 4

Brief 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).

Conditions

Cough; Upper Respiratory Tract Infection

Keywords

cough; common cold; antitussive agents; mucosal protection; medical device

Outcome Measures

Primary Outcomes (1)

• Change in Night Cough Score on First Night of Treatment (From N0 to N1)

  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.

  1 night from before enrollment (N0) to first night after treatment (N1)

Secondary Outcomes (2)

• Change in Night Cough Score at End of Study (From N0 to N4)

  4 nights (onset of trial Night 1 to Night 4) and 3 days

• Change in Day Cough Score at End of Study (From D0 to D4)

  4 nights (onset of trial Night 1 to Night 4) and 3 days

Study Arms (2)

protective cough syrup

EXPERIMENTAL

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

carbocisteine cough syrup

ACTIVE COMPARATOR

Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)

Drug: carbocisteine cough syrup

Interventions

protective cough syrup DEVICE

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.

Also known as: Grintuss

protective cough syrup

carbocisteine cough syrup DRUG

Mucolytic

Also known as: Mucolit, Lisomucil

carbocisteine cough syrup

Eligibility Criteria

• Age: 2 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• cough attributed to URTI such as the common cold
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clalit Health Services: lead
• Aboca Spa Societa' Agricola: collaborator

Study Sites (4)

Pediatric Ambulatory Clinic Bat-Yam

Bat Yam, Israel

Location

Pediatric Ambulatory Clinic Kfar-Saba

Kfar Saba, Israel

Location

Pediatric Community Ambulatory Clinic - Petach-Tikva

Petah Tikva, Israel

Location

Pediatric Ambulatory Clinic Ramat Aviv Gimel

Tel Aviv, Israel

Location

Related Publications (11)

• Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.

  PMID: 16841784 BACKGROUND

• Paul IM, Yoder KE, Crowell KR, Shaffer ML, McMillan HS, Carlson LC, Dilworth DA, Berlin CM Jr. Effect of dextromethorphan, diphenhydramine, and placebo on nocturnal cough and sleep quality for coughing children and their parents. Pediatrics. 2004 Jul;114(1):e85-90. doi: 10.1542/peds.114.1.e85.

  PMID: 15231978 BACKGROUND

• Paul IM, Beiler J, McMonagle A, Shaffer ML, Duda L, Berlin CM Jr. Effect of honey, dextromethorphan, and no treatment on nocturnal cough and sleep quality for coughing children and their parents. Arch Pediatr Adolesc Med. 2007 Dec;161(12):1140-6. doi: 10.1001/archpedi.161.12.1140.

  PMID: 18056558 BACKGROUND

• 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.

  BACKGROUND

• Allen KL, Molan PC, Reid GM. A survey of the antibacterial activity of some New Zealand honeys. J Pharm Pharmacol. 1991 Dec;43(12):817-22. doi: 10.1111/j.2042-7158.1991.tb03186.x.

  PMID: 1687577 BACKGROUND

• Schramm DD, Karim M, Schrader HR, Holt RR, Cardetti M, Keen CL. Honey with high levels of antioxidants can provide protection to healthy human subjects. J Agric Food Chem. 2003 Mar 12;51(6):1732-5. doi: 10.1021/jf025928k.

  PMID: 12617614 BACKGROUND

• Cohen HA, Rozen J, Kristal H, Laks Y, Berkovitch M, Uziel Y, Kozer E, Pomeranz A, Efrat H. Effect of honey on nocturnal cough and sleep quality: a double-blind, randomized, placebo-controlled study. Pediatrics. 2012 Sep;130(3):465-71. doi: 10.1542/peds.2011-3075. Epub 2012 Aug 6.

  PMID: 22869830 BACKGROUND

• Bogdanov S, Jurendic T, Sieber R, Gallmann P. Honey for nutrition and health: a review. J Am Coll Nutr. 2008 Dec;27(6):677-89. doi: 10.1080/07315724.2008.10719745.

  PMID: 19155427 BACKGROUND

• Rimsza ME, Newberry S. Unexpected infant deaths associated with use of cough and cold medications. Pediatrics. 2008 Aug;122(2):e318-22. doi: 10.1542/peds.2007-3813.

  PMID: 18676517 BACKGROUND

• Kraft K. Efficacy of fluid in Plantago lanceolata extract (PLFE) in acute respiratory disease. Phytomedicine, Supplement 1, 1996

  BACKGROUND

• Wegener T, Kraft K. [Plantain (Plantago lanceolata L.): anti-inflammatory action in upper respiratory tract infections]. Wien Med Wochenschr. 1999;149(8-10):211-6. German.

  PMID: 10483683 BACKGROUND

MeSH Terms

Conditions

Cough; Respiratory Tract Infections; Common Cold

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Results Point of Contact

• Title: Prof. Herman Avner Cohen
• Organization: Clalit HS

hermanc@clalit.org.il

00972 3-939-8203

Study Officials

• Herman Avner Cohen, Professor

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. Head Dep. Pediatric Ambulatory Clinic -Petah-Tikva, Israel

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 24, 2013
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: February 23, 2018
• Results First Posted: November 2, 2015

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (4)