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

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ClinicalTrials.gov Identifier: NCT02045550
Recruitment Status : Unknown
Verified January 2014 by Technische Universität Dresden.
Recruitment status was:  Recruiting
First Posted : January 27, 2014
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
Technische Universität Dresden

January 13, 2014
January 27, 2014
January 27, 2014
January 2014
August 2015   (Final data collection date for primary outcome measure)
the time to event (next bronchitis episode) rate during and after treatment period [ Time Frame: three months ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
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
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Acute Wheezy Bronchitis
  • Recurrent Bronchitis
Drug: Prospan Syrup
2.5 ml twice daily for 4 weeks
  • Placebo Comparator: Placebo Syrup
    Placebo Syrup 2.5 ml twice daily for 4 weeks
  • Active Comparator: Prospan Syrup
    Prospan Syrup 2.5 ml twice daily for 4 weeks
    Intervention: Drug: Prospan Syrup
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
60
Same as current
August 2015
August 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
1 Year to 3 Years   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT02045550
HeHe02
Yes
Not Provided
Not Provided
Technische Universität Dresden
Technische Universität Dresden
Not Provided
Principal Investigator: Christian Vogelberg, MD PhD Technische Universität Dresden
Technische Universität Dresden
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP