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

Cough Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259674
• Other study ID #: AB-Resp-09
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2010
• Last updated: December 1, 2014
• Start date: October 2010
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: Aboca Spa Societa' Agricola
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Italian Ministry of Health - Innovation Department,Office IV - Clinical trials with medical devices -
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 6 Years

Eligibility

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cough

Intervention

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

Other:
• Placebo
Placebo syrup: 5ml to be taken 4 times a day during the entire study period

Locations

Country	Name	City	State
Italy	Santa Maria della Misercordia di Udine Hospital	Udine

Sponsors (2)

Lead Sponsor	Collaborator
Aboca Spa Societa' Agricola	Sprim Advanced Life Sciences

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough score variation	Clinical diurnal and nocturnal cough score (Chung)	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)	No
Secondary	Cough reflex sensitivity	Capsaicin test - Cough Reflex Index (CRI) -	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)	No
Secondary	Objective breath sounds	Wheezometer test	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)	No
Secondary	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)	No
Secondary	Quality of life	Quality of life questionnaire (QoL)	Measured at Baseline Visit (day 0) and at the Last Visit (day 8)	No