Clinical trial NCT01259674: Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cough
Keywords: Pediatric
children
acute cough
treatment
syrup
protective natural extracts
Lead sponsor: Aboca Spa Societa' Agricola
Sponsor class: INDUSTRY
Collaborators: name: Sprim Advanced Life Sciences
First posted: 2010-12-14
Enrollment: 102
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

Primary outcomes:
measure: Cough score variation
timeFrame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Secondary outcomes:
measure: Cough reflex sensitivity
timeFrame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
measure: Objective breath sounds
timeFrame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
measure: The ventilation of the various pulmonary zones
timeFrame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
measure: Quality of life
timeFrame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Other outcomes:
Locations:
city: Udine
country: Italy
facility: Santa Maria della Misercordia di Udine Hospital
Study officials:
affiliation: Sprim Advanced Life Sciences
name: Arienne de Jong, PhD
role: STUDY_CHAIR
References: