NCT02045550UnknownPhase 2
Tolerance and Effect of a Prophylactical Treatment With a Cough Medicine Con-taining Ivy Leaves Dry Extract in Children With Recurrent Wheezy Bronchitis
Technische Universität Dresden1 site in 1 country60 target enrollmentStarted: January 2014Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- the time to event (next bronchitis episode) rate during and after treatment period
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Year to 3 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Medical diagnosis of ≥3 episodes of wheezy bronchitis within the pre-vious 12 months
- •Children aged from 1 to 3 years (girls and boys)
- •Signed Informed Consent of the legal guardians to participate in the trial after written and verbal briefing by the Investigator
- •No allergic sensitization
- •Allowance to contact the familys pediatrician for medical history of wheezy bronchitis episodes
Exclusion Criteria
- •Anamnestically known intolerance/allergy to one of the drugs applied or to their ingredients or to drugs of similar chemical structure
- •Participation of the patient in another clinical trial within the last four weeks before enrollment in this trial
- •Evidence suggesting that the patient or their legal representative is not likely to follow the trial protocol (e.g. lacking compliance)
- •Inability to document the symptoms in a symptom log book or ques-tionnaire; inability to take the trial medication properly
- •Any regular therapy except Vitamin D or Fluoride
- •Chronic illnesses of different aetiology
- •Premature birth or diagnosis of bronchopulmonary dysplasia
- •Gastro-oesophageal reflux
- •Hereditary fructose intolerance
Arms & Interventions
Prospan Syrup
Active Comparator
Prospan Syrup 2.5 ml twice daily for 4 weeks
Intervention: Prospan Syrup (Drug)
Outcomes
Primary Outcomes
the time to event (next bronchitis episode) rate during and after treatment period
Time Frame: three months
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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