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Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough (ABOMEG)

Primary Purpose

Cough

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
AboMeg-B-09
Placebo
Sponsored by
Aboca Spa Societa' Agricola
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring Pediatric, children, acute cough, treatment, syrup, protective natural extracts

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Children aged between 3 and 6
  • Acute cough - lasting 1-3 weeks
  • Written informed consent by the parents/legal tutors
  • Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study
  • Parents/legal tutors must be willing to comply with the study protocol

Exclusion Criteria:

  • Children treated with immunostimulators and immune regulating drugs during the last month before starting the study
  • Children with immunodeficiencies or immune suppression
  • Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases
  • Children treated with antibiotics, including prophylactic treatment
  • Children being treated with systemic corticosteroids - including oral aerosol inhaler
  • Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month
  • Children who have participated in previous studies with experimental products within the last month
  • Children with asthma or suspected diagnosis of asthma
  • Children with bacterial diseases - Pneumonia, Sepsis
  • Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo
  • Children allergic to any study product ingredients
  • Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary

Sites / Locations

  • Santa Maria della Misercordia di Udine Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AboMeg-B-09 syrup

Placebo

Arm Description

Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period

Placebo syrup

Outcomes

Primary Outcome Measures

Cough score variation
Clinical diurnal and nocturnal cough score (Chung)

Secondary Outcome Measures

Cough reflex sensitivity
Capsaicin test - Cough Reflex Index (CRI) -
Objective breath sounds
Wheezometer test
The ventilation of the various pulmonary zones
Vibration Response Imaging (VRI) xp test
Quality of life
Quality of life questionnaire (QoL)

Full Information

First Posted
December 13, 2010
Last Updated
December 1, 2014
Sponsor
Aboca Spa Societa' Agricola
Collaborators
Sprim Advanced Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01259674
Brief Title
Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough
Acronym
ABOMEG
Official Title
Randomized, Single-center, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Tolerability of ABO/MEG-B-09 in Pediatric Cough
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aboca Spa Societa' Agricola
Collaborators
Sprim Advanced Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The present clinical trial will examine the use of ABO/MEG-B-09 syrup in children with acute cough as compared to a placebo syrup.
Detailed Description
Subjects will be asked to take 4 doses of 5 ml containing a mixture of honey and other natural ingredients or a placebo syrup everyday, during 8 days. The following outcomes will be noted down in a diary: occurence and severity of diurnal and nocturnal cough events (cough score) and symptoms, impediment of normal life activities (school, sleeping), the number of medical visits and type of medication needed if any.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
Pediatric, children, acute cough, treatment, syrup, protective natural extracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AboMeg-B-09 syrup
Arm Type
Experimental
Arm Description
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo syrup
Intervention Type
Device
Intervention Name(s)
AboMeg-B-09
Intervention Description
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo syrup: 5ml to be taken 4 times a day during the entire study period
Primary Outcome Measure Information:
Title
Cough score variation
Description
Clinical diurnal and nocturnal cough score (Chung)
Time Frame
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Secondary Outcome Measure Information:
Title
Cough reflex sensitivity
Description
Capsaicin test - Cough Reflex Index (CRI) -
Time Frame
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Title
Objective breath sounds
Description
Wheezometer test
Time Frame
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Title
The ventilation of the various pulmonary zones
Description
Vibration Response Imaging (VRI) xp test
Time Frame
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Title
Quality of life
Description
Quality of life questionnaire (QoL)
Time Frame
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children aged between 3 and 6 Acute cough - lasting 1-3 weeks Written informed consent by the parents/legal tutors Parents/legal tutors must be willing not to give to the child other medications or products for the treatment of cough during the study period, unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study Parents/legal tutors must be willing to comply with the study protocol Exclusion Criteria: Children treated with immunostimulators and immune regulating drugs during the last month before starting the study Children with immunodeficiencies or immune suppression Children with chronic diseases - Pulmonary Diseases, Renal insufficiency, Heart diseases Children treated with antibiotics, including prophylactic treatment Children being treated with systemic corticosteroids - including oral aerosol inhaler Children with potential immunosuppressive viral diseases - Measles, Chickenpox, Rubella, Infectious mononucleosis - within the last month Children who have participated in previous studies with experimental products within the last month Children with asthma or suspected diagnosis of asthma Children with bacterial diseases - Pneumonia, Sepsis Children with diabetes because of the high content of sugar of the study products - ABO/MEG-B-09 and placebo Children allergic to any study product ingredients Children/Parents/legal tutors with psychological condition that may, in the investigator's opinion, adversely affect their co-operation with the study protocol - syrup administration or compilation of the diary
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arienne de Jong, PhD
Organizational Affiliation
Sprim Advanced Life Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Santa Maria della Misercordia di Udine Hospital
City
Udine
ZIP/Postal Code
33100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough

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