Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-24 @ 5:14 PM
NCT ID:
NCT02045550
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
3 Years
Study:
NCT02045550
Study Brief:
Protocol Section:
NCT02045550