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

December 1, 2014 updated by: Aboca Spa Societa' Agricola

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
102

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Udine, Italy, 33100
        • Santa Maria della Misercordia di Udine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: AboMeg-B-09 syrup
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
Device: AboMeg-B-09
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
Placebo Comparator: Placebo
Placebo syrup
Other: Placebo
Placebo syrup: 5ml to be taken 4 times a day during the entire study period

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cough reflex sensitivity
Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Capsaicin test - Cough Reflex Index (CRI) -
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Objective breath sounds
Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Wheezometer test
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
The ventilation of the various pulmonary zones
Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Vibration Response Imaging (VRI) xp test
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Quality of life
Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Quality of life questionnaire (QoL)
Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aboca Spa Societa' Agricola

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sprim Advanced Life Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Arienne de Jong, PhD, Sprim Advanced Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 13, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 14, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 2, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AB-Resp-09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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