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

NCT01259674 | Completed Phase 3

• 1 other identifier: AB-Resp-09
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Keywords

Pediatric; children; acute cough; treatment; syrup; protective natural extracts

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• Cough reflex sensitivity

  Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

• Objective breath sounds

  Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

• The ventilation of the various pulmonary zones

  Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

• Quality of life

  Measured at Baseline Visit (day 0) and at the Last Visit (day 8)

Study Arms (2)

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

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

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aboca Spa Societa' Agricola: lead
• Sprim Advanced Life Sciences: collaborator

Study Sites (1)

Santa Maria della Misercordia di Udine Hospital

Udine, Udine, 33100, Italy

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arienne de Jong, PhD

  Sprim Advanced Life Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: October 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

IT (1)