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

Aboca Spa Societa' Agricola1 site in 1 country102 target enrollmentOctober 2010

ConditionsCough

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Cough
Sponsor: Aboca Spa Societa' Agricola
Enrollment: 102
Locations: 1
Primary Endpoint: Cough score variation
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2010

End Date

April 2011

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Aboca Spa Societa' Agricola

Responsible Party

Sponsor

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

Outcomes

Primary Outcomes

Cough score variation

Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

Clinical diurnal and nocturnal cough score (Chung)

Secondary Outcomes

Cough reflex sensitivity(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))
The ventilation of the various pulmonary zones(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))
Quality of life(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))
Objective breath sounds(Measured at Baseline Visit (day 0) and at the Last Visit (day 8))