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

Technische Universität Dresden

Status and phase: Unknown; Phase 2

Conditions: Recurrent Bronchitis; Acute Wheezy Bronchitis

Treatments: Drug: Prospan Syrup

Study type: Interventional

Funder types: Other

Identifiers

NCT02045550

HeHe02

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 3 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Placebo Syrup

Placebo Comparator group

Description:

Placebo Syrup 2.5 ml twice daily for 4 weeks

Prospan Syrup

Active Comparator group

Description:

Prospan Syrup 2.5 ml twice daily for 4 weeks

Treatment:

Drug: Prospan Syrup