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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Aboca Spa Societa' Agricola.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Sprim Advanced Life Sciences
Information provided by:
Aboca Spa Societa' Agricola
ClinicalTrials.gov Identifier:
NCT01259674
First received: December 13, 2010
Last updated: December 16, 2010
Last verified: December 2010
  Purpose

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.


Condition Intervention Phase
Cough
Device: AboMeg-B-09
Other: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Aboca Spa Societa' Agricola:

Primary Outcome Measures:
  • Cough score variation [ Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8) ] [ Designated as safety issue: No ]
    Clinical diurnal and nocturnal cough score (Chung)


Secondary Outcome Measures:
  • Cough reflex sensitivity [ Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8) ] [ Designated as safety issue: No ]
    Capsaicin test - Cough Reflex Index (CRI) -

  • Objective breath sounds [ Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8) ] [ Designated as safety issue: No ]
    Wheezometer test

  • The ventilation of the various pulmonary zones [ Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8) ] [ Designated as safety issue: No ]
    Vibration Response Imaging (VRI) xp test

  • Quality of life [ Time Frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8) ] [ Designated as safety issue: No ]
    Quality of life questionnaire (QoL)


Estimated Enrollment: 102
Study Start Date: October 2010
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   3 Years to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259674

Locations
Italy
Santa Maria della Misercordia di Udine Hospital Recruiting
Udine, Italy, 33100
Contact: Mario Canciani, PhD    +39 0432 559244    canciani.mario@aoud.sanita.fvg.it   
Principal Investigator: Mario Canciani, PhD         
Sponsors and Collaborators
Aboca Spa Societa' Agricola
Sprim Advanced Life Sciences
Investigators
Study Chair: Arienne de Jong, PhD Sprim Advanced Life Sciences
  More Information

No publications provided

Responsible Party: Aboca Spa Societa' Agricola, Aboca - Address: Frazione Aboca 20 - 52037 Sansepolcro, Arezzo, Italy
ClinicalTrials.gov Identifier: NCT01259674     History of Changes
Other Study ID Numbers: AB-Resp-09
Study First Received: December 13, 2010
Last Updated: December 16, 2010
Health Authority: Italy: Italian Ministry of Health - Innovation Department,Office IV - Clinical trials with medical devices -

Keywords provided by Aboca Spa Societa' Agricola:
Pediatric
children
acute cough
treatment
syrup
protective natural extracts

Additional relevant MeSH terms:
Cough
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014