Clinical trial NCT02486835: Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Official title: Efficacy & Tolerability of a Specific Plantain,Thyme and Honey Cough Syrup vs Placebo in Child Cough Due to Common Cold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cough
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2015-07-01
Enrollment: 150
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cough is a life saving reflex, therefore it is important, especially in pediatrics, to calm cough spells without sedating the reflex. The intent of this study is to use a protective syrup with does not act as a sedative or as a potent mucolytic and measure its efficacy and safety versus placebo in children with moderate to severe night and daily cough. Cough is assessed with a validated parent questionnaire. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

Detailed 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 not been done so far, in very young children, especially in a time frame of 4 days. 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. The degree of disturbance of cough is followed immediately after one night administration of the study products and daily for 4 nights, 3 days.

Assessment of effectiveness of the protective cough syrup as compared to placebo is considered very interesting due to the mechanism of the remedy.

Eligibility criteria: Inclusion Criteria:

* cough attributed to infection of the upper respiratory tract since less or equal than 7 days,
* children aged 1 to 5 years
* score of three or more of al least two of the following three questions relating to night cough, frequency of nocturnal cough, impact on sleep of child and impact on sleep of parent,
* score of at least three of all questions assessing daytime cough considering the day prior to study entry
* written consent by a parent.

Exclusion Criteria:

* 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 cough syrup.

Primary outcomes:
measure: Change in night cough frequency score in the general population
timeFrame: baseline up to night 1
Secondary outcomes:
measure: Change in night cough frequency score in the population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough frequency score in the female population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough frequency score in the male population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough severity score in the general population
timeFrame: baseline up to night 1
measure: Change in night cough severity score in the population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough bothersomeness score in the general population
timeFrame: baseline up to night 1
measure: Change in night cough bothersomeness score in the population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough influence on sleep of child score in the general population
timeFrame: baseline up to night 1
measure: Change in night cough influence on sleep of child score in the population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough influence on sleep of parent score in the general population
timeFrame: baseline up to night 1
measure: Change in night cough influence on sleep of parent score in the population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in night cough combined score in the general population
timeFrame: baseline up to night 1
measure: Change in night cough combined score in the population coughing since 1-2 days
timeFrame: baseline up to night 1
measure: Change in day cough frequency score in the general population
timeFrame: baseline up to day 2
Other outcomes:
Locations:
city: Bat Yam
country: Israel
facility: Pediatric Ambulatory Clinic Bat-Yam
city: Kfar Saba
country: Israel
facility: Pediatric Ambulatory Clinic Kfar-Saba
city: Petaẖ Tiqwa
country: Israel
facility: Pediatric Community Ambulatory Clinic - Petach-Tikva
city: Tel Aviv
country: Israel
facility: Pediatric Ambulatory Clinic Ramat Aviv Gimel
Study officials:
affiliation: Clalit HS
name: Herman A Cohen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Middleton KR, Hing E. National Hospital Ambulatory Medical Care Survey: 2004 outpatient department summary. Adv Data. 2006 Jun 23;(373):1-27.
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. doi: 10.1542/peds.114.1.e85.
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. doi: 10.1001/archpedi.161.12.1140.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
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.