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 @ 12:22 PM
Ignite Modification Date:
2025-12-24 @ 12:22 PM
NCT ID:
NCT00305461
Eligibility Criteria:
Main Inclusion Criteria:
* Written informed consent
* Good health with the exception of asthma
* Clinical diagnosis of moderate persistent asthma during the last 6 months prior to visit B0
* Pre-treatment with inhaled corticosteroids dose equivalent to 250 - 500 mcg BDP / day at stable dosing during the last 4 weeks prior to visit B0, concomitant or not to short-acting beta2-agonists treatment as rescue medication
* FEV1 ≥ 70% and ≤ 90% predicted measured at least 4 h after the last use of rescue medication at visit B0
* Reversibility ≥ 12% and ≥ 200 mL in B0, B0 or T0, after inhalation of 400 mcg of salbutamol
* Patients compliant to recommended pre-treatment
Main Exclusion Criteria:
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Chronic obstructive pulmonary disease (COPD)
* Hospitalization within previous four weeks from baseline
* Hospitalization due to asthma within the last twelve months
* Asthma exacerbation within two months previous to baseline
* History of almost fatal asthma at any moment
* Pregnancy, breast feeding, intention to become pregnant during the course of the study or lack of safe contraception in pre-menopausal women
* Exacerbation of asthma within 2 months prior to entry into the baseline period
* Use of systemic steroids up to 2 months (injectable depot steroids 6 months) before entry into the baseline period, or more than 3 times during the last 6 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT00305461
Study Brief:
Protocol Section:
NCT00305461