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

Aboca

Status and phase: Completed; Phase 3

Conditions: Cough

Treatments: Device: AboMeg-B-09; Other: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01259674

AB-Resp-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 3 to 6 years old

Volunteers: No Healthy Volunteers

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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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102 participants in 2 patient groups, including a placebo group

AboMeg-B-09 syrup

Experimental group

Description:

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

Treatment:

Device: AboMeg-B-09

Placebo

Placebo Comparator group

Description:

Placebo syrup

Treatment:

Other: Placebo