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

NCT03218696 | Unknown

• 1 other identifier: COM-17-0096
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Cough; Acute Upper Respiratory Tract Infection

Keywords

cough; children; Acute Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• night cough intensity score reduction

  First and only night of treatment

• night cough bothersomeness score reduction

  First and only night of treatment

• reduction of influence of cough on child sleep score

  First and only night of treatment

• reduction of influence of cough on parent sleep score

  First and only night of treatment

• reduction of influence of cough on combined night score

  First and only night of treatment

Study Arms (2)

Cough Syrup for adults and children

EXPERIMENTAL

CE Marked (authorized) medical device acting by protecting the oropharynx, in a non-pharmacological way, to reduce cough. It contains honey, plantago lanceolata, thymus vulgaris. Dosage form: syrup Dosage: 5 ml. Duration: one night

Device: Cough Syrup for adults and children

Placebo

PLACEBO COMPARATOR

The placebo intervention is a similar syrup of taste and colour, with general protective components and other necessary synthetic components which may have an influence on cough, without the specific natural protective components. Dosage form: syrup. Dosage: 5 ml. Duration: one night

Device: Placebo

Interventions

Cough Syrup for adults and children DEVICE

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.

Also known as: Poliflav M.A.-honey cough syrup

Cough Syrup for adults and children

Placebo DEVICE

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.

Placebo

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Cough attributed to infection of the upper respiratory tract present in the child for not more than 2 days.
• Children aged 1 year to 5 (ie: 1 day before the 6th birthday, males and females)
• 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,
• Score of at least 3 to all three questions assessing "daytime" cough considering the day prior to study entry.
• Written signed consent by a parent.

You may not qualify if:

• \. 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.
• \. Children who received antihistamines or any cough medicine the day prior to study entry.
• \. The administration of any steroid preparation by oral administration or inhalation on the day prior to study entry.
• \. 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".

Sponsors & Collaborators

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

Study Sites (2)

Pediatric Community Ambulatory Clinic - Petach-Tikva

Petah Tikva, Israel

Location

Pediatric Community Ambulatory Clinic

Petah Tikva, Israel

Location

Related Publications (15)

• Eccles R. The powerful placebo in cough studies? Pulm Pharmacol Ther. 2002;15(3):303-8. doi: 10.1006/pupt.2002.0364.

  PMID: 12099783 BACKGROUND

• Eccles R. Mechanisms of the placebo effect of sweet cough syrups. Respir Physiol Neurobiol. 2006 Jul 28;152(3):340-8. doi: 10.1016/j.resp.2005.10.004. Epub 2005 Dec 2.

  PMID: 16326149 BACKGROUND

• 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. No abstract available.

  PMID: 24453088 BACKGROUND

• 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.

  PMID: 20015366 BACKGROUND

• Canciani M, Murgia V, Caimmi D, Anapurapu S, Licari A, Marseglia GL. Efficacy of Grintuss(R) 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.

  PMID: 24917119 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

• 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.

  PMID: 27457790 BACKGROUND

• 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.

  PMID: 21892785 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

• 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

• 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. doi: 10.1177/0009922806291014.

  PMID: 16928841 BACKGROUND

• 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.

  PMID: 21185164 BACKGROUND

• 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.

  PMID: 23597834 BACKGROUND

• 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. doi: 10.1021/np010636j.

  PMID: 12088434 BACKGROUND

• 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.

  PMID: 20618098 BACKGROUND

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

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

Study Officials

• Herman A Cohen, Prof.

  Clalit Health Services

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Herman A Cohen, Prof.

CONTACT

+ 972-3- 9398203; hermanc@clalit.org.il

Yifat Atias, Dr.

CONTACT

+ 972-3- 9398200; ifatat@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: According to a predertermined list, the two products are provided in identical bottles and cartons appropriately labelled so as to ensure respect of the randomization list as well as blinding of all study participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Herman Avner Cohen

Model Details: Parallel randomized double blind

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 14, 2017
• Study Start: February 1, 2018
• Primary Completion: September 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 29, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)