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 @ 4:06 AM
Ignite Modification Date:
2025-12-25 @ 4:06 AM
NCT ID:
NCT00174720
Eligibility Criteria:
Inclusion Criteria:
* Males or females 12 years or older
* History of persistent bronchial asthma for at least 6 months
* Documented use of bronchodilators (short acting only) only or methylxanthines for at least 1 month before screening
* At screening, FEV1 60 to 90% of predicted. Reversibility of FEV1 by at least 12% post-bronchodilator
* Be able to use oral inhalers
* Non-smokers
Exclusion Criteria:
* History of life-threatening asthma
* Other pulmonary diseases
* URI within 4 weeks before screening
* Use of systemic steroids within 6 months before screening. Use of inhaled steroids within 30 days before screening. More than 2 in-patient hospitalizations or ER visits due to asthma exacerbations in the prior year before screening
* Pregnant or breast-feeding females
* Females of child-bearing potential not using adequate means of birth control
* Clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease
* Abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results
* History of drug or alcohol abuse
* Treatment with any investigational product within 30 days prior to study entry
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Study:
NCT00174720
Study Brief:
Protocol Section:
NCT00174720