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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2014 by Technische Universität Dresden.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02045550
First Posted: January 27, 2014
Last Update Posted: January 27, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Technische Universität Dresden
  Purpose
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.

Condition Intervention Phase
Acute Wheezy Bronchitis Recurrent Bronchitis Drug: Prospan Syrup Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • the time to event (next bronchitis episode) rate during and after treatment period [ Time Frame: three months ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: January 2014
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Prospan Syrup
2.5 ml twice daily for 4 weeks

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 3 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02045550


Contacts
Contact: Christian Vogelberg, MD PhD 0049351458 ext 5699 christian.vogelberg@uniklinikum-dresden.de

Locations
Germany
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin Recruiting
Dresden, Saxonia, Germany, 01307
Contact: Christian Vogelberg, MD PhD    0049351458 ext 2073    christian.vogelberg@uniklinikum-dresden.de   
Sub-Investigator: Sabine Zeil, MD         
Principal Investigator: Christian Vogelberg, MD PhD         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Christian Vogelberg, MD PhD Technische Universität Dresden
  More Information

Responsible Party: Technische Universität Dresden
ClinicalTrials.gov Identifier: NCT02045550     History of Changes
Other Study ID Numbers: HeHe02
First Submitted: January 13, 2014
First Posted: January 27, 2014
Last Update Posted: January 27, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Bronchitis
Acute Disease
Bronchiolitis
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases