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

NCT02045550 | Unknown Phase 2 DMC

• 1 other identifier: HeHe02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Wheezy Bronchitis; Recurrent Bronchitis

Outcome Measures

Primary Outcomes (1)

• the time to event (next bronchitis episode) rate during and after treatment period

  three months

Secondary Outcomes (2)

• 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

Study Arms (2)

Placebo Syrup

PLACEBO COMPARATOR

Placebo Syrup 2.5 ml twice daily for 4 weeks

Prospan Syrup

ACTIVE COMPARATOR

Prospan Syrup 2.5 ml twice daily for 4 weeks

Drug: Prospan Syrup

Interventions

Prospan Syrup DRUG

2.5 ml twice daily for 4 weeks

Prospan Syrup

Eligibility Criteria

• Age: 1 Year - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Kinder- und Jugendmedizin

Dresden, Saxony, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Christian Vogelberg, MD PhD

  Technische Universität Dresden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian Vogelberg, MD PhD

CONTACT

0049351458; christian.vogelberg@uniklinikum-dresden.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2014
• First Posted: January 27, 2014
• Study Start: January 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

DE (1)