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Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis

Primary Purpose

Acute Wheezy Bronchitis, Recurrent Bronchitis

Status

Unknown status

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Prospan Syrup

About this trial

This is an interventional prevention trial for Acute Wheezy Bronchitis

Eligibility Criteria

1 Year - 3 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
Children aged from 1 to 3 years (girls and boys)
Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
No allergic sensitization
Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes

Exclusion Criteria:

Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
Any regular therapy except Vitamin D or Fluoride
Chronic illnesses of different aetiology
Premature birth or diagnosis of bronchopulmonary dysplasia
Gastro-oesophageal reflux
Hereditary fructose intolerance

Sites / Locations

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und JugendmedizinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo Syrup

Prospan Syrup

Arm Description

Placebo Syrup 2.5 ml twice daily for 4 weeks

Prospan Syrup 2.5 ml twice daily for 4 weeks

Outcomes

Primary Outcome Measures

the time to event (next bronchitis episode) rate during and after treatment period

Secondary Outcome Measures

days and percentage of days without bronchitis during and after treatment period

days and percentage of days without bronchitis during treatment period

Full Information

NCT ID

NCT02045550

First Posted

January 13, 2014

Last Updated

January 23, 2014

Sponsor

Technische Universität Dresden

1. Study Identification

Unique Protocol Identification Number

NCT02045550

Brief Title

Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis

Official Title

Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Technische Universität Dresden

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To evaluate the effect of a prophylactical therapy with a cough medicine containing ivy leaves dry extract on the frequency of recurrent wheezy bronchitis in toddlers, on the duration of the bronchitis episodes, on the severity and the additional drug demand. A prolonged asymptomatic episode between each wheezy bronchitis due to the therapy is assumed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Wheezy Bronchitis, Recurrent Bronchitis

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo Syrup

Arm Type

Placebo Comparator

Arm Description

Placebo Syrup 2.5 ml twice daily for 4 weeks

Arm Title

Prospan Syrup

Arm Type

Active Comparator

Arm Description

Prospan Syrup 2.5 ml twice daily for 4 weeks

Intervention Type

Drug

Intervention Name(s)

Prospan Syrup

Intervention Description

2.5 ml twice daily for 4 weeks

Primary Outcome Measure Information:

Title

the time to event (next bronchitis episode) rate during and after treatment period

Time Frame

three months

Secondary Outcome Measure Information:

Title

days and percentage of days without bronchitis during and after treatment period

Time Frame

3 months

Title

days and percentage of days without bronchitis during treatment period

Time Frame

three months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months Children aged from 1 to 3 years (girls and boys) Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator No allergic sensitization Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes Exclusion Criteria: Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance) Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly Any regular therapy except Vitamin D or Fluoride Chronic illnesses of different aetiology Premature birth or diagnosis of bronchopulmonary dysplasia Gastro-oesophageal reflux Hereditary fructose intolerance

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Christian Vogelberg, MD PhD

Phone

0049351458

Ext

5699

christian.vogelberg@uniklinikum-dresden.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christian Vogelberg, MD PhD

Organizational Affiliation

Technische Universität Dresden

Official's Role

Principal Investigator

Facility Information:

Facility Name

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin

City

Dresden

State/Province

Saxonia

ZIP/Postal Code

01307

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Christian Vogelberg, MD PhD

Phone

0049351458

Ext

2073

christian.vogelberg@uniklinikum-dresden.de

First Name & Middle Initial & Last Name & Degree

Sabine Zeil, MD

First Name & Middle Initial & Last Name & Degree

Christian Vogelberg, MD PhD

12. IPD Sharing Statement

Learn more about this trial

Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis

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