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:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00366067
Eligibility Criteria:
Inclusion Criteria:
1. Patients between 10 and 14, patients parents or supervisors must have given their informed consent before commencing the procedures specified in the protocol, indicating that they understand the objectives of the study and are willing to adhere to the procedures described in the protocol.
2. Patients able to use peak flow meters, to perform spirometry and to swallow capsules.
3. Patient aged between 4 and 14 years, males or females.
4. Out patients.
5. Patients with an established (i.e. at least 6 months) clinical history of asthma.
6. Absence of long-term remissions of asthma (lasting more than 1 month)
7. Poorly controlled asthma, due to various reasons.
Exclusion Criteria:
1. History or presence of cardiovascular, renal, neurologic, psychiatric, liver, immunologic, endocrine, infection or other diseases or dysfunctions if they are clinically significant. A clinically significant disease is defined as one which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study.
2. Patients with active tuberculosis with indication for treatment.
3. Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis or if the abnormal defines a disease listed as an exclusion criterion.
4. Patients with known allergy, side effects, intolerance/hypersensitivity to investigational drug
5. Patients currently using MAO inhibitors, tricyclic antidepressants, antiepileptic drugs, narcotic agents.
6. Patients between 10 and 14, parents or supervisor of patients unlikely, unable or unwilling to comply with the requirements of the protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
14 Years
Study:
NCT00366067
Study Brief:
Protocol Section:
NCT00366067