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

Phase 2

• Conditions: Acute Wheezy Bronchitis; Recurrent Bronchitis
• Interventions: Drug: Prospan Syrup

• Registration Number: NCT02045550
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2014-01
• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-23
• Last Update Submitted: 2014-01-23
• Study First Posted: 2014-01-27
• Last Update Posted: 2014-01-27
• Primary Completion: 2015-08
• Study Completion: 2015-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospan Syrup	Prospan Syrup	Prospan Syrup 2.5 ml twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
the time to event (next bronchitis episode) rate during and after treatment period	three months

Secondary Outcome Measures

Name	Time	Method
days and percentage of days without bronchitis during and after treatment period	3 months
days and percentage of days without bronchitis during treatment period	three months

Trial Locations

Locations (1)

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin; 🇩🇪 Dresden, Saxonia, Germany