Comparison of a Protective Cough Syrup Against Placebo on Night Cough in Children 1-5 Years Coughing Since 1- 2 Days Due to Common Cold

Cough Clinical Trial

Official title:

A Randomized, Double-blind Study to Evaluate the Efficacy and Tolerability of a Cough Syrup Containing Specific Plant Extracts (Poliflav M.A.) and Honey Versus Placebo in Cough Due to Upper Respiratory Tract Infection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03218696
• Other study ID #: COM-17-0096
• Status: Not yet recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: January 25, 2018
• Start date: February 2018
• Est. completion date: December 2018

Study information

• Verified date: January 2018
• Source: Clalit Health Services
• Contact: Herman A Cohen, Prof.
• Phone: + 972-3- 9398203
• Email: hermanc[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The intent of this study is to see how boys and girls aged 1-5 and coughing since 1-2 days due to common cold respond to a specific protective cough syrup taken before going to bed for one night, with respect to a similar but not specific syrup (placebo). The symptoms evaluated include especially cough frequency but also cough intensity, bother, and sleep quality of the child and parents.

Description:

Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. Looking into mechanisms for cough management different from mucolytics, or sedatives, 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 and thymus vulgaris) and placebo has been looked at specifically on the clinically critical population of children coughing since 1-2 days and not more, including very young children of one year old. The intent of this study is to use the protective syrup versus placebo in children with moderate to severe night and daily cough, measured with a validated parent questionnaire. Daily cough is assessed to better describe and select the general condition of the child however only night cough parameters due to treatment are assessed. The degree of disturbance of cough is followed immediately after one night administration on all night parameters, with special interest to frequency.

Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy. The study looks at the effect of the syrup/placebo on the first night in order to well focus the "first" effect of a treatment on the ascending phase of the illness, such as to reduce to a minimum any interference due to natural regression of the symptom due to illness progression.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 5 Years

Eligibility

Inclusion Criteria:

1. Cough attributed to infection of the upper respiratory tract present in the child for not more than 2 days.

2. Children aged 1 year to 5 (ie: 1 day before the 6th birthday, males and females)

3. Score of at least 3 to two of the following three questions relating to the evaluation of night cough: frequency of nocturnal cough, impact on the sleep of the child and impact on the sleep of the parent,

4. Score of at least 3 to all three questions assessing "daytime" cough considering the day prior to study entry.

5. Written signed consent by a parent.

Exclusion Criteria:

• 1. Children with a diagnosis of acute: laryngotracheal bronchitis, pneumonia, asthma, sinusitis, allergic rhinitis, as well as chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies.

2. Children who received antihistamines or any cough medicine the day prior to study entry.

3. The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry.

4. Known sensitivity to any component of placebo or to Plantago lanceolata or Thymus vulgaris, honey or any other component of the "Poliflav M.A.-honey cough syrup".

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infection
• Cough
• Infection
• Respiratory Tract Infections

Intervention

Device:
• Cough Syrup for adults and children
The intervention product is a medical device in Europe due to its non-pharmacological mode of action, which makes the product compliant to the medical device definition. It is made of specific extracts of plants (plantago and thymus) which provide the product with protective characteristics of the oropharynx. These protective features enable the syrup to reduce the irritative cough promoting stimuli on the throat, which decrease urge to cough threshhold. In addition to these extract, honey completes the formula. The product does not contain any artificial component and no preservatives.
• Placebo
The placebo intervention is a syrup of same taste and colour without the natural protective components but with the necessary synthetic preservatives and other co-sweeteners to guarantee quality and safety. The placebo has, in fact, all the features of a cough syrup since true placebo syrup is not possible in cough. The lack of specific natural protective components is weighed against the presence of other necessary substances which may still have an effect on cough, but this effect is not envisaged to be a specific protective effect.

Locations

Country	Name	City	State
Israel	Pediatric Community Ambulatory Clinic	Peta? Tiqwa
Israel	Pediatric Community Ambulatory Clinic - Petach-Tikva	Peta? Tiqwa

Sponsors (2)

Lead Sponsor	Collaborator
Clalit Health Services	Aboca Spa Societa' Agricola

Country where clinical trial is conducted

Israel, 

References & Publications (15)

Canciani M, Murgia V, Caimmi D, Anapurapu S, Licari A, Marseglia GL. Efficacy of Grintuss® pediatric syrup in treating cough in children: a randomized, multicenter, double blind, placebo-controlled clinical trial. Ital J Pediatr. 2014 Jun 10;40:56. doi: 10.1186/1824-7288-40-56. — View Citation

Cohen HA, Hoshen M, Gur S, Bahir A, Laks Y, Blau H. Efficacy and tolerability of a polysaccharide-resin-honey based cough syrup as compared to carbocysteine syrup for children with colds: a randomized, single-blinded, multicenter study. World J Pediatr. 2017 Feb;13(1):27-33. doi: 10.1007/s12519-016-0048-4. Epub 2016 Jul 15. — View Citation

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. — View Citation

Dapkevicius A, van Beek TA, Lelyveld GP, van Veldhuizen A, de Groot A, Linssen JP, Venskutonis R. Isolation and structure elucidation of radical scavengers from Thymus vulgaris leaves. J Nat Prod. 2002 Jun;65(6):892-6. — View Citation

Dicpinigaitis PV, Bhat R, Rhoton WA, Tibb AS, Negassa A. Effect of viral upper respiratory tract infection on the urge-to-cough sensation. Respir Med. 2011 Apr;105(4):615-8. doi: 10.1016/j.rmed.2010.12.002. Epub 2010 Dec 24. — View Citation

Dicpinigaitis PV, Colice GL, Goolsby MJ, Rogg GI, Spector SL, Winther B. Acute cough: a diagnostic and therapeutic challenge. Cough. 2009 Dec 16;5:11. doi: 10.1186/1745-9974-5-11. — View Citation

Eccles R. Mechanisms of the placebo effect of sweet cough syrups. Respir Physiol Neurobiol. 2006 Jul 28;152(3):340-8. Epub 2005 Dec 2. Review. — View Citation

Eccles R. The powerful placebo in cough studies? Pulm Pharmacol Ther. 2002;15(3):303-8. Review. — View Citation

Hurst JR, Saleh AD. Neither anti-inflammatory nor antibiotic treatment significantly shortens duration of cough in acute bronchitis compared with placebo. Evid Based Med. 2014 Jun;19(3):98. doi: 10.1136/eb-2013-101643. Epub 2014 Jan 22. — View Citation

Nosalova G, Fleskova D, Jurecek L, Sadlonova V, Ray B. Herbal polysaccharides and cough reflex. Respir Physiol Neurobiol. 2013 Jun 1;187(1):47-51. doi: 10.1016/j.resp.2013.03.015. Epub 2013 Apr 15. — View Citation

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. — View Citation

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. — View Citation

Paul IM. Therapeutic options for acute cough due to upper respiratory infections in children. Lung. 2012 Feb;190(1):41-4. doi: 10.1007/s00408-011-9319-y. Epub 2011 Sep 4. Review. — View Citation

Shadkam MN, Mozaffari-Khosravi H, Mozayan MR. A comparison of the effect of honey, dextromethorphan, and diphenhydramine on nightly cough and sleep quality in children and their parents. J Altern Complement Med. 2010 Jul;16(7):787-93. doi: 10.1089/acm.2009.0311. — View Citation

Yoder KE, Shaffer ML, La Tournous SJ, Paul IM. Child assessment of dextromethorphan, diphenhydramine, and placebo for nocturnal cough due to upper respiratory infection. Clin Pediatr (Phila). 2006 Sep;45(7):633-40. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Night cough frequency score reduction	Night cough frequency is the most invasive element of distress to the child and family. The questionnaire rating night cough is filled in the morning following enrollment, relating to the passed night. The basal night score is the score of the night before enrollment.	First and only night of treatment
Secondary	night cough intensity score reduction	All these other elements constitute cough invasiveness into the quality of life of child and parents	First and only night of treatment
Secondary	night cough bothersomeness score reduction	All these other elements constitute cough invasiveness into the quality of life of child and parents	First and only night of treatment
Secondary	reduction of influence of cough on child sleep score	All these other elements constitute cough invasiveness into the quality of life of child and parents	First and only night of treatment
Secondary	reduction of influence of cough on parent sleep score	All these other elements constitute cough invasiveness into the quality of life of child and parents	First and only night of treatment
Secondary	reduction of influence of cough on combined night score	All these other elements constitute cough invasiveness into the quality of life of child and parents	First and only night of treatment