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

Acute Wheezy Bronchitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02045550
• Other study ID #: HeHe02
• Status: Recruiting
• Phase: Phase 2
• First received: January 13, 2014
• Last updated: January 23, 2014
• Start date: January 2014
• Est. completion date: August 2015

Study information

• Verified date: January 2014
• Source: Technische Universität Dresden
• Contact: Christian Vogelberg, MD PhD
• Phone: 0049351458
• Email: christian.vogelberg[@]uniklinikum-dresden.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 3 Years

Eligibility

Inclusion Criteria:

1. Medical diagnosis of =3 episodes of wheezy bronchitis within the pre-vious 12 months

2. Children aged from 1 to 3 years (girls and boys)

3. Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator

4. No allergic sensitization

5. Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes

Exclusion Criteria:

1. Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure

2. Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial

3. Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)

4. Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly

5. Any regular therapy except Vitamin D or Fluoride

6. Chronic illnesses of different aetiology

7. Premature birth or diagnosis of bronchopulmonary dysplasia

8. Gastro-oesophageal reflux

9. Hereditary fructose intolerance

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Disease
• Acute Wheezy Bronchitis
• Asthma
• Bronchitis
• Recurrent Bronchitis

Intervention

Drug:
• Prospan Syrup
2.5 ml twice daily for 4 weeks

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin	Dresden	Saxonia

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the time to event (next bronchitis episode) rate during and after treatment period		three months	No
Secondary	days and percentage of days without bronchitis during and after treatment period		3 months	No
Secondary	days and percentage of days without bronchitis during treatment period		three months	No