Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005899

Trial Description

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Title

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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00005899
  •   2015/03/03
  •   2014/01/13
  •   yes
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Secondary IDs

  •   NCT02045550  (ClinicalTrials.gov)
  •   HeHe02  (Technische Universität Dresden)
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Health Condition or Problem studied

  •   Acute Wheezy Bronchitis
  •   Recurrent Bronchitis
  •   J20 -  Acute bronchitis
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Interventions/Observational Groups

  •   Drug: Prospan Syrup
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Blinded
  •   patient/subject, investigator/therapist
  •   Placebo
  •   Prevention
  •   Parallel
  •   II
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Primary Outcome

- the time to event (next bronchitis episode) rate during and after treatment period; time frame: three months

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Secondary Outcome

- days and percentage of days without bronchitis during and after treatment period; time frame: 3 months
- days and percentage of days without bronchitis during treatment period; time frame: three months

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/01/31
  •   60
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Inclusion Criteria

  •   Both, male and female
  •   1   Years
  •   3   Years
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Additional 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

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Technische Universität Dresden
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    • Technische Universität Dresden
    • Christian Vogelberg, MD PhD 
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    • Christian Vogelberg, MD PhD 
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    end of 1:1-Block address contact public-contact
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/02/23
* This entry means the parameter is not applicable or has not been set.