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:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
NCT ID:
NCT03344406
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older at the time of consent.
* History of airflow obstruction as indicated by a pre-bronchodilator forced expiratory volume in one second (FEV1) \<80 percent predicted recorded in the previous 12 months.
* Documented evidence of a reversibility assessment within the previous 12 months, which demonstrated a post-bronchodilator increase in FEV1 of \>=12 percent and \>= 200 milliliters (mL).
* Diagnosed with moderate or severe asthma as defined by a stable maintenance inhaled corticosteroid (ICS) dose for at least 12 weeks prior to screening of; moderate: medium ICS dose \> 250 and \<=500 micrograms per day (mcg/day) fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose; Severe: high ICS dose \> 500 mcg/day fluticasone propionate (or equivalent) based on the total daily maintenance treatment dose.
* Documented control status defined using the asthma control questionnaire (ACQ-6) items (ACQ-6) obtained at the time of screening.
* Able to understand, read and speak English or Spanish sufficiently to complete all assessments.
* Willing and able to take part in a telephone interview session.
* Willing and able to provide written informed consent.
Exclusion Criteria:
* Is a current smoker.
* Has any medical condition that would preclude participation in this study, including the presence of emphysema or chronic bronchitis (COPD other than asthma) or a clinically important lung condition other than asthma such as current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis or diagnoses of an eosinophilic disorder such as eosinophilic esophagitis or a history of lung cancer.
* Participated in an interventional study within the past 30 days.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03344406
Study Brief:
Protocol Section:
NCT03344406