Tezepelumab Home Use Study

Phase 1

• Conditions: Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]; Severe uncontrolled asthma; MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

• Registration Number: EUCTR2018-004588-30-PL
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-24
• Last Update Posted: 26 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 210

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

- 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
visit 1.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified