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 @ 4:12 AM
Ignite Modification Date:
2025-12-25 @ 4:12 AM
NCT ID:
NCT00546520
Eligibility Criteria:
Main inclusion criteria:
* Out-patients
* Written informed consent
* History of atopic disease
* History of perennial bronchial asthma for at least 6 months as defined by ATS criteria
* Current use of only inhaled short acting beta-2-agonist as required (for at least 4 weeks prior to baseline period B0)
* Stable asthma, i.e. no exacerbation or relevant respiratory tract infection within 2 months prior to study start
* FEV1 ≥ 70% predicted
* Hyperreactivity to AMP (PC20FEV1 \< 25 mg/ml)
* Good health with the exception of asthma
* Non-smokers as well as ex-smokers with either = 10 pack-years or more than 6 months of smoking abstinence
Main exclusion criteria:
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids (e.g. lung tuberculosis)
* Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
* Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 3 times during the last 6 months
* Pregnancy or intention to become pregnant during the course of the study, breast feeding, lack of safe contraception in heterosexually active female patients of child-bearing potential, or postmenopausal for less than one year
* COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases
* Known or suspected hypersensitivity to inhaled steroids or to the other excipients of the metered dose inhalers
* Immunotherapy within one month prior to B0 and/or during the entire study duration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00546520
Study Brief:
Protocol Section:
NCT00546520