A Multicenter, Randomized, Open-label, Parallel group, Functionality, and Performance Study of an Accessorized Pre-filled Syringe and Autoinjector with Home-administered Subcutaneous Tezepelumab in Adolescent and Adult Subjects with Severe Asthma (PATH-HOME) - PATH-HOME

AstraZeneca AB0 个研究点目标入组 210 人开始时间: 2019年4月24日最近更新: 2020年10月26日

试验速览

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•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

•- 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 <10 pack years, as well
•as users of electronic cigarettes (e.g. vaping) must have stopped for at
•least 6 months prior to Visit 1 to be eligible.
•- History of alcohol or drug abuse within 12 months prior to Visit 1.
•- Tuberculosis requiring treatment within 12 months prior to Visit 1.
•- HIV, Hepatitis B or Hepatitis C.
•- Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
•- Bronchial thermoplasty in the 24 months prior to Visit 1.
•- Anaphylaxis or documented immune complex disease to any biologic therapy.
•- Evidence of active liver disease, including jaundice or aspartate transaminase, alanine transaminase, or alkaline phosphatase >2 times the upper limit of normal at Visit 1.
•- Non-leukocyte depleted whole blood transfusion in 120 days prior to

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