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

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02045550

Enrollment

Registered

2014-01-27

Start date

2014-01-31

Completion date

2015-08-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Wheezy Bronchitis, Recurrent Bronchitis

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.

Interventions

DRUGProspan Syrup

2.5 ml twice daily for 4 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 3 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Germany

Contacts

Primary ContactChristian Vogelberg, MD PhD

christian.vogelberg@uniklinikum-dresden.de0049351458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026