Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children

NCT04073251 | Completed

• 1 other identifier: KTC
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice. In the majority of cases, it is self-limiting, but its persistence could become exasperating and it could reduce quality of life and social activities. Even if inappropriate prescription of antitussive pharmacological treatment in children has been reduced, pediatrics prescribing attitudes do not still always are reflecting accurate treatment of cough. Furthermore, pediatric approach is always compromised by parental exaggerate perception of symptoms and usual consequent requirement of pharmacological prescription of antibiotics, that they consider the appropriate and effective therapeutic option for cough. The World Health Organization identifies honey as a potential demulcent treatment for cough. On the light of the above considerations and since available pediatric treatments for acute cough are limited by lack of demonstrated efficacy, a pediatric cough syrup product containing Acacia honey as well as specific fractions of resins, polysaccharides, saponins, flavonoids and sugars derived from Malva sylvestris extract, Inula helenium, Plantago major extract, Helichrysum stoechas (KalobaTuss) was developed to be clinically tested on persisting cough of children. Investigators evaluated through a randomized, double blind controlled clinical study the effects of KalobaTuss on persistent cough in children aging 3-6 years. The effects of Kalobatuss were compared with effects of placebo on nocturnal and daytime persistent cough for eight days. Objective of the study was to evaluate the clinical efficacy of KalobaTuss by using as primary endpoint the assessment of changes in day- and night-time cough score.

Conditions

Cough

Keywords

Persistent cough; Children

Outcome Measures

Primary Outcomes (1)

• Assessment of efficacy of treatment of cough persistent

  Primary endpoint is the assessment of changes in day- and night-time cough score. Cough was diagnosed and evaluated by the pediatrician during the first visit and monitored by parents by filling a daily diary. At the end of the administration period pediatrician visited again children and collected the daily diary for each child.

  8 weeks

Study Arms (2)

KalobaTuss children

EXPERIMENTAL

KalobaTuss children syrup 5 ml for 4 times a day supplied for 8 consecutive days.

Dietary Supplement: KalobaTuss children

Placebo

PLACEBO COMPARATOR

Placebo syrup 5 ml for 4 times a day supplied for 8 consecutive days.

Dietary Supplement: Placebo

Interventions

KalobaTuss children DIETARY_SUPPLEMENT

Syrup, dosage: 5 ml for 4 times a day for 8 days.

KalobaTuss children

Placebo DIETARY_SUPPLEMENT

Syrup, dosage: 5 ml for 4 times a day for 8 days.

Placebo

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children aged between 3 and 6 years, with persistent cough for at least three consecutive days.

You may not qualify if:

• Children with history of obstructive pulmonary diseases, cystic fibrosis, neuropathies, heart disease, diabetes and immunodeficiencies were excluded.

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, Me, 98125, Italy

Location

Related Publications (11)

• De Blasio F, Dicpinigaitis PV, Rubin BK, De Danieli G, Lanata L, Zanasi A. An observational study on cough in children: epidemiology, impact on quality of sleep and treatment outcome. Cough. 2012 Jan 23;8(1):1. doi: 10.1186/1745-9974-8-1.

  PMID: 22269875 BACKGROUND

• Zanasi A, Morcaldi L, Cazzato S, Mazzolini M, Lecchi M, Morselli-Labate AM, Mastroroberto M, Dal Negro RW. Survey on attitudes of Italian pediatricians toward cough. Clinicoecon Outcomes Res. 2017 Mar 16;9:189-199. doi: 10.2147/CEOR.S129696. eCollection 2017.

  PMID: 28352199 BACKGROUND

• French CT, Irwin RS, Fletcher KE, Adams TM. Evaluation of a cough-specific quality-of-life questionnaire. Chest. 2002 Apr;121(4):1123-31. doi: 10.1378/chest.121.4.1123.

  PMID: 11948042 BACKGROUND

• Dal Negro RW, Mazzolini M, Turco P, Zanasi A. Cough: impact, beliefs, and expectations from a national survey. Multidiscip Respir Med. 2016 Sep 27;11:34. doi: 10.1186/s40248-016-0072-1. eCollection 2016.

  PMID: 27708777 BACKGROUND

• Rousounidis A, Papaevangelou V, Hadjipanayis A, Panagakou S, Theodoridou M, Syrogiannopoulos G, Hadjichristodoulou C. Descriptive study on parents' knowledge, attitudes and practices on antibiotic use and misuse in children with upper respiratory tract infections in Cyprus. Int J Environ Res Public Health. 2011 Aug;8(8):3246-62. doi: 10.3390/ijerph8083246. Epub 2011 Aug 5.

  PMID: 21909304 BACKGROUND

• Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in community settings. Cochrane Database Syst Rev. 2014 Nov 24;2014(11):CD001831. doi: 10.1002/14651858.CD001831.pub5.

  PMID: 25420096 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

• 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

• Chung KF. Assessment and measurement of cough: the value of new tools. Pulm Pharmacol Ther. 2002;15(3):267-72. doi: 10.1006/pupt.2002.0360.

  PMID: 12099776 BACKGROUND

• Weinberger M, Lockshin B. When is cough functional, and how should it be treated? Breathe (Sheff). 2017 Mar;13(1):22-30. doi: 10.1183/20734735.015216.

  PMID: 28289448 BACKGROUND

• Carnevali I, La Paglia R, Pauletto L, Raso F, Testa M, Mannucci C, Sorbara EE, Calapai G. Efficacy and safety of the syrup "KalobaTUSS(R)" as a treatment for cough in children: a randomized, double blind, placebo-controlled clinical trial. BMC Pediatr. 2021 Jan 11;21(1):29. doi: 10.1186/s12887-020-02490-2.

  PMID: 33430841 DERIVED

MeSH Terms

Conditions

Cough; Chronic Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gioacchino Calapai, MD

  Azienda Ospedaliera Universitaria "G Martino", Messina, Italy.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: FULL PROFESSOR OF PHARMACOLOGY AND TOXICOLOGY

Model Details: Randomized, double-blind controlled clinical study .

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 29, 2019
• Study Start: February 15, 2019
• Primary Completion: May 3, 2019
• Study Completion: May 10, 2019
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)