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

Cough research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study - Parents/legal tutors must be willing to comply with the study protocol Exclusion Criteria: - Children treated with immunostimulators and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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cough

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

PlaceboPlacebo syrup

Study Status

Completed

Start Date: October 2010

Completed Date: April 2011

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: Cough score variation

Secondary Outcome: Cough reflex sensitivity

Study sponsors, principal investigator, and references

Principal Investigator: Arienne de Jong, PhD

Lead Sponsor: Aboca Spa Societa' Agricola

Collaborator: Sprim Advanced Life Sciences

More information:https://clinicaltrials.gov/show/NCT01259674

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