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 @ 6:59 PM
Ignite Modification Date:
2025-12-24 @ 6:59 PM
NCT ID:
NCT03927157
Eligibility Criteria:
Inclusion Criteria:
* Age. 18-80
* Documented physician-diagnosed asthma for at least 12 months
* Participants who have received a physician-prescribed asthma controller medication with medium or high dose ICS for at least 6 months.
* Documented treatment with a total daily dose of either medium or high dose ICS (≥ 500 µg fluticasone propionate dry powder formulation equivalent total daily dose) for at least 3 months.
* At least one additional maintenance asthma controller medication is required according to standard practice of care and must be documented for at least 3 months.
* Morning pre-BD FEV1 \<80% predicted normal
* Evidence of asthma as documented by either: Documented historical reversibility of FEV1 ≥12% and ≥200 mL in the previous 12 months OR Post-BD (albuterol/salbutamol) reversibility of FEV1 ≥12% and ≥200 mL during screening.
* Documented history of at least 2 asthma exacerbation events within 12 months, and at least one of the exacerbations should occur during the treatment of medium-to-high dose ICS.
* ACQ-6 score ≥1.5 at screening and on day of randomization
Exclusion Criteria:
* Pulmonary disease other than asthma.
* History of cancer.
* History of a clinically significant infection.
* Current smokers or participants with smoking history ≥10 pack-yrs.
* History of chronic alcohol or drug abuse within 12 months.
* Hepatitis B, C or HIV.
* Pregnant or breastfeeding.
* History of anaphylaxis following any biologic therapy.
* participant randomized in the current study or previous tezepelumab studies.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03927157
Study Brief:
Protocol Section:
NCT03927157