CoughPhase 3ABOMEGNCT01259674
Evaluation of the Efficacy and Tolerability of ABO/MEG-B-09 in Children With Acute Cough
A Phase 3 study testing AboMeg-B-09 in people with Cough, run by Aboca Spa Societa' Agricola at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 years
- Conditions the study is for
- Cough
- What is being tested?
- AboMeg-B-09
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2010to Apr 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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unless they become clinically indicated in which case a rescue regimen can be administered and the child will be withdrawn from the study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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cough
- Being tested
- AboMeg-B-09, Placebo
- Keywords
- Pediatric, children, acute cough, treatment, syrup, protective natural extracts
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AboMeg-B-09Device
Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
PlaceboOther
Placebo syrup: 5ml to be taken 4 times a day during the entire study period
| Study group | Role | What they receive |
|---|---|---|
| AboMeg-B-09 syrup | Experimental | Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period Receives: Device: AboMeg-B-09 |
| Placebo | Placebo comparator | Placebo syrup Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough score variation
Clinical diurnal and nocturnal cough score (Chung)
Measured: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Secondary outcomes (4)
Cough reflex sensitivity
Capsaicin test - Cough Reflex Index (CRI) -
Measured: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Objective breath sounds
Wheezometer test
Measured: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
The ventilation of the various pulmonary zones
Vibration Response Imaging (VRI) xp test
Measured: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Quality of life
Quality of life questionnaire (QoL)
Measured: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aboca Spa Societa' Agricola
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Arienne de Jong, PhD, Study chair, Sprim Advanced Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259674
- Sponsor's protocol ID
- AB-Resp-09
- Acronym
- ABOMEG
- Status last verified
- Dec 2014
- First submitted
- 13 Dec 2010
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01259674
- Acronym / sponsor ID
- ABOMEG / AB-Resp-09
- Conditions
- Cough
- Keywords
- Pediatric, children, acute cough, treatment, syrup, protective natural extracts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Aboca Spa Societa' AgricolaIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Oct 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AboMeg-B-09 syrup | Experimental | Device: AboMeg-B-09Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period |
| Placebo | Placebo comparator | Other: PlaceboPlacebo syrup |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AboMeg-B-09Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period | Device | AboMeg-B-09 syrup |
| PlaceboPlacebo syrup: 5ml to be taken 4 times a day during the entire study period | Other | Placebo |
Primary outcome
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)
4 secondary outcomes
Cough reflex sensitivity
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Objective breath sounds
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
The ventilation of the various pulmonary zones
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Quality of life
Time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arienne de Jong, PhD study chair
Sprim Advanced Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AboMeg-B-09 in people with Cough, run by Aboca Spa Societa' Agricola at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough score variation (time frame: Measured at Baseline Visit (day 0) and at the Last Visit (day 8)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.