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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT01455194
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent was provided
* History of persistent bronchial asthma for at least 6 months
* Current treatment with an Inhaled Corticosteroid (ICS) at a stable dose in the dose range of 200-1000 μg Fluticasone Propionate (FP)/day or equivalent for a minimum of 12 weeks
* Good inhalation technique
* Under the current ICS pre-treatment the ACQ score ranges between ≥ 0.75 and ≥ 2
Exclusion Criteria:
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Concomitant severe diseases (e.g. malignant diseases during the past 5 years \[other than basal or squamous cell carcinoma\], hepatitis C, acquired immune deficiency syndrome \[AIDS\])
* Diseases which are contraindications for the use of ICS (e.g. active or inactive pulmonary tuberculosis or relevant fungal, bacterial or viral infections of the lower respiratory tract demanding specific treatment)
* Use of systemic glucocorticosteroids within 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
70 Years
Study:
NCT01455194
Study Brief:
Protocol Section:
NCT01455194