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

Phase 3

Completed

• Conditions: Cough
• Interventions: Device: AboMeg-B-09; Other: Placebo

• Registration Number: NCT01259674
• Lead Sponsor: Aboca Spa Societa' Agricola

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.

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-12-13
• Study First Submitted QC: 2010-12-13
• Study First Posted: 2010-12-14
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Cough score variation	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)	Clinical diurnal and nocturnal cough score (Chung)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Santa Maria della Misercordia di Udine Hospital; 🇮🇹 Udine, Italy