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Completed

NCT Number: NCT01259674

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

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Key information

Conditions

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

Age range

3 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Santa Maria della Misercordia di Udine Hospital

Udine, 33100, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

Treatment and study plan

AboMeg-B-09

Device

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

Placebo

Other

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

Primary outcomes

  1. 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)

Secondary outcomes

  1. Cough reflex sensitivity

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

    Capsaicin test - Cough Reflex Index (CRI) -

  2. Objective breath sounds

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

    Wheezometer test

  3. 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

  4. Quality of life

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

    Quality of life questionnaire (QoL)

Sponsors and collaborators

Lead sponsor

Aboca Spa Societa' Agricola

Industry

Collaborators

  • Sprim Advanced Life Sciences

Registry information

Official study title

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

Acronym: ABOMEG

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Dec 14, 2010
Registry last updated
Dec 2, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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