Evaluation of the Efficacy and Tolerability of ABO/MEG-B-... | NCT01259674

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

NCT01259674

Sponsor

Aboca Spa Societa' Agricola

Status

Completed

Last Update Posted

Dec 2, 2014Estimated

Enrollment

102Actual

Phase

Phase 3

Conditions

Cough

Interventions

AboMeg-B-09
Placebo

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2010

Primary Completion Date

Apr 2011Actual

Completion Date

Apr 2011Actual

First Submitted Date

Dec 13, 2010

First Submission Date that Met QC Criteria

Dec 13, 2010

First Posted Date

Dec 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2014

Last Update Posted Date

Dec 2, 2014Estimated

Name	Class
Sprim Advanced Life Sciences	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

102Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AboMeg-B-09 syrup	Experimental	Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period	Device: AboMeg-B-09
Placebo	Placebo Comparator	Placebo syrup	Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AboMeg-B-09	Device	Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period	AboMeg-B-09 syrup

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012818	Signs and Symptoms, Respiratory
D012816	Signs and Symptoms