Acute Wheezy Bronchitis | Tolerance and Effect of a Prophylactical Treatment With Ivy Leaves Dry Extract in Recurrent Wheezy Bronchitis
Acute Wheezy Bronchitis research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Wheezy Bronchitis
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Prospan Syrup2.5 ml twice daily for 4 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Placebo SyrupPlacebo Syrup 2.5 ml twice daily for 4 weeks
Prospan SyrupProspan Syrup 2.5 ml twice daily for 4 weeks
Start Date: January 2014
Completed Date: August 2015
Phase: Phase 2
Primary Outcome: the time to event (next bronchitis episode) rate during and after treatment period
Secondary Outcome: days and percentage of days without bronchitis during and after treatment period
Study sponsors, principal investigator, and references
Principal Investigator: Christian Vogelberg, MD PhD
Lead Sponsor: Technische Universität Dresden