Severe uncontrolled asthma MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria? Male and female subjects aged 12 to 80 years of age at the time of Visit 1? Documented physician-diagnosed asthma for at least 12 months prior to Visit 1? Evidence of asthma as documented by post BD (albuterol/salbutamol) reversibility of FEV1 = 12% AND =200 mL (15-60 min after administration of 4 puffs of albuterol/salbutamol), documented either: in the previous12 months prior to V1, OR demonstrated at V1, V1A, or at V2?. Documented history of current treatment with medium- or high-dose ICS for at least 6 months prior to Visit 1 and at least one additional asthma controller medication for at least 3 months prior to Visit 1?. Morning pre-bronchodilator (pre-BD) FEV1 of >50% predicted normal at Visit 1, Visit 1A, or Visit 2?. Are the trial subjects under 18? yes Number of subjects for this age range: 20 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 170 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Any clinically important pulmonary disease other than asthma. - History of cancer except basal cell carcinoma, squamous cell carcinoma of the skin, or in situ carcinoma of the cervix within 12 months prior to Visit 1. - A helminth parasitic infection diagnosed within 6 months prior to Visit 1. - Current smokers or former smokers with a smoking history of =10 pack years. Former smokers with a smoking history of 2 times the upper limit of normal at Visit 1. - Non-leukocyte depleted whole blood transfusion in 120 days prior to visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the successful administration of tezepelumab (210 mg, subcutaneous) by injection with an accessorized prefilled syringe (APFS) or autoinjector (AI) in the clinic and at home.;Secondary Objective: To assess the functionality of the APFS or AI devices utilized to administer tezepelumab in clinic and at home. To assess the performance of APFS or AI devices used to administer tezepelumab in clinic and at home. To monitor the metrics of asthma control in subjects. To assess the pharmacokinetics and immunogenicity of tezepelumab administered via APFS or AI in clinic and at home, and to assess the safety and tolerability of tezepelumab.;Primary end point(s): Proportion of healthcare providers (HCPs) and subjects/caregivers who successfully administered tezepelumab in clinic and at home with APFS. Proportion of healthcare providers (HCPs) and subjects/caregivers who successfully administered tezepelumab in clinic and at home with AI.;Timepoint(s) of evaluation of this end point: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Week 0, Week 4, Week 8, Week 12, Week 16, Week 20. Week 0, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 (for ACQ-6 score change from baseline, serum trough concentrations and ADA levels);Secondary end point(s): Proportion of used/returned APFS devices that passed functional tests and visual inspection and showed no evidence of malfunction. Proportion of used/returned AI devices that passed functional tests and visual inspection and showed no evidence of malfunction. Proportion of APFS devices that have been reported as malfunctioning (as per the Product Complaints process). Proportion of AI devices that have been reported as malfunctioning (as per the Product Complaints process). Change from baseline in Asthma Control Questionnaire-6 (ACQ-6) scores. Serum trough tezepelumab concentrations and anti-drug antibody (ADA) levels. | — |
Countries
Canada, Japan, Poland, United States
Outcome results
None listed