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 @ 1:41 PM
Ignite Modification Date:
2025-12-24 @ 1:41 PM
NCT ID:
NCT01704495
Eligibility Criteria:
Inclusion Criteria:
* Men and women aged 18 years and above. Females of childbearing potential must use a highly effective contraceptive method plus a condom by their male partner.
* Diagnosis of asthma for at least 12 months (GINA 2011)
* Uncontrolled persistent asthma, despite treatment with medium to high dose ICS and LABA, and with a history of exacerbations during the last year
* Morning prebronchodilator FEV1 of ≥30% and ≤85% predicted normal at enrolment
* Daily use of medium or high dose ICS (≥fluticasone 500 µg or the equivalent daily)
Exclusion Criteria:
* Any clinically significant disease or disorder (including any chronic lower respiratory disease other than asthma) that may put the patient at risk or influence study results
* Patients with recurrent, latent, or chronic infections
* Active tuberculosis or latent tuberculosis without completion of an appropriate course of treatment or prophylactic treatment
* Significant lower respiratory tract infection not resolved within 30 days prior to enrolment
* Current smoker or smoking history of more than 20 pack years
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
150 Years
Study:
NCT01704495
Study Brief:
Protocol Section:
NCT01704495