Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218696
Recruitment Status : Not yet recruiting
First Posted : July 14, 2017
Last Update Posted : January 29, 2018
Sponsor:
Collaborator:
Aboca Spa Societa' Agricola
Information provided by (Responsible Party):
Avner Herman Cohen, Clalit Health Services

Tracking Information
First Submitted Date  ICMJE July 12, 2017
First Posted Date  ICMJE July 14, 2017
Last Update Posted Date January 29, 2018
Estimated Study Start Date  ICMJE February 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
Night cough frequency score reduction [ Time Frame: First and only night of treatment ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03218696 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2017)
  • night cough intensity score reduction [ Time Frame: First and only night of treatment ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents
  • night cough bothersomeness score reduction [ Time Frame: First and only night of treatment ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents
  • reduction of influence of cough on child sleep score [ Time Frame: First and only night of treatment ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents
  • reduction of influence of cough on parent sleep score [ Time Frame: First and only night of treatment ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents
  • reduction of influence of cough on combined night score [ Time Frame: First and only night of treatment ]
    All these other elements constitute cough invasiveness into the quality of life of child and parents
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
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 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel randomized double blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE
  • Cough
  • Acute Upper Respiratory Tract Infection
Intervention  ICMJE
  • 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.
    Other Name: Poliflav M.A.-honey cough syrup
  • Device: 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.
Study Arms  ICMJE
  • Experimental: Cough Syrup for adults and children
    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
    Intervention: Device: Cough Syrup for adults and children
  • Placebo Comparator: Placebo
    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
    Intervention: Device: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date September 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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".

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 5 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Herman A Cohen, Prof. + 972-3- 9398203 hermanc@clalit.org.il
Contact: Yifat Atias, Dr. + 972-3- 9398200 ifatat@clalit.org.il
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218696
Other Study ID Numbers  ICMJE COM-17-0096
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Avner Herman Cohen, Clalit Health Services
Study Sponsor  ICMJE Clalit Health Services
Collaborators  ICMJE Aboca Spa Societa' Agricola
Investigators  ICMJE
Principal Investigator: Herman A Cohen, Prof. Clalit Health Services
PRS Account Clalit Health Services
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP