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

Randomized, Single-center, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Tolerability of ABO/MEG-B-09 in Pediatric Cough

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.

Study Overview

• Status: Completed
• Conditions: Cough
• Intervention / Treatment: Device: AboMeg-B-09; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • Udine, Italy, 33100
    • Santa Maria della Misercordia di Udine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AboMeg-B-09 syrup; Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period	Device: AboMeg-B-09; Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
Placebo Comparator: Placebo; Placebo syrup	Other: Placebo; Placebo syrup: 5ml to be taken 4 times a day during the entire study period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough score variation	Clinical diurnal and nocturnal cough score (Chung)	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough reflex sensitivity	Capsaicin test - Cough Reflex Index (CRI) -	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Objective breath sounds	Wheezometer test	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
The ventilation of the various pulmonary zones	Vibration Response Imaging (VRI) xp test	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Quality of life	Quality of life questionnaire (QoL)	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

Collaborators and Investigators

• Sponsor: Aboca Spa Societa' Agricola
• Collaborators: Sprim Advanced Life Sciences
• Investigators: Study Chair: Arienne de Jong, PhD, Sprim Advanced Life Sciences

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: December 13, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: December 1, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: treatment; Pediatric; children; syrup; acute cough; protective natural extracts
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: AB-Resp-09