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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT01197794
Eligibility Criteria:
Inclusion Criteria:
* Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
* 6 months history of asthma according to ATS definition
* Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
* Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
* A total ACQ5 score of 1.5 or more
Exclusion Criteria:
* Respiratory infection significantly affecting the asthma
* Any significant disease and disorder that may put the patient at risk or influence study results
* Any clinically relevant abnormal findings
* A smoking history of more than 10 pack years
* Intake of oral, rectal or parenteral glucocorticosteroids
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01197794
Study Brief:
Protocol Section:
NCT01197794