Actively Recruiting
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD A Randomized Double-blind, Placebo-controlled Trial of Tezepelumab UPSTREAM-COPD
Led by Asger Sverrild · Updated on 2024-08-21
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Asger Sverrild
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of tezepelumab on airway inflammation in patients with chronic obstructive pulmonary disease (COPD) who have experienced at least one exacerbation in the past year. This phase 2, multicenter, randomized, double-blind, placebo-controlled study focuses on patients already using maintenance treatments like LABA and LAMA, with or without ICS. The study aims to understand how blocking TSLP impacts inflammation and the immune response in the airways of people with COPD. Participants will be randomly assigned to receive either tezepelumab or a placebo through subcutaneous injections at the study site. The treatment period lasts 20 weeks, with five doses administered at four-week intervals. The study includes two groups: one receiving tezepelumab 210 mg and the other receiving placebo injections, both under blinded conditions to ensure unbiased results. During the study, researchers will assess airway inflammation through tissue analysis focusing on specific immune cells such as eosinophils, neutrophils, mast cells, CD4+ and CD8+ cells, and macrophages. Participants will undergo evaluations including lung function tests and monitoring of inhaler use. Safety and treatment effects will be closely observed throughout the 20-week period. The study aims to provide detailed insights into how tezepelumab influences airway inflammation in COPD.
CONDITIONS
Brief Title
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Diagnosis of COPD according to GOLD 2021 report
- Current or ex-smokers with at least 10 packyears
- Age 40 years or older
- Postbronchodilator FEV1 between 30% and 80% predicted and at least 1.0L
- Maintenance treatment with LAMA+LABA, with or without ICS, at stable dose for at least 3 months prior to first visit
- At least one prednisolone and/or antibiotic treated exacerbation in the past 12 months
- Demonstrated acceptable inhaler and spirometry techniques during screening
- At least 70% compliance with daily inhalers during screening/run-in
- Females of childbearing potential who are sexually active with nonsterilized male partner must use effective contraception from consent through Week 20
You will not qualify if you...
- Uncontrolled intercurrent illness that may affect safety or study participation
- Other respiratory diseases interfering with study evaluation (e.g., cystic fibrosis, pulmonary fibrosis, aspergillosis, active tuberculosis)
- Current asthma
- Lung volume reduction surgery for COPD
- Exacerbation requiring oral corticosteroids or antibiotics more than 3 days within 4 weeks prior to first visit or during run-in
- Use of home oxygen therapy
- Clinically relevant abnormal lab results or vital signs that risk safety or affect study results
- History of cancer except basal cell carcinoma or cervical carcinoma in situ treated over 12 months ago, or other malignancies treated over 5 years ago
- Recent respiratory infections requiring antibiotics or antivirals within 4 weeks prior to first visit
- Positive HIV test or taking antiretroviral medications
- Positive hepatitis B or C tests or history, except for hepatitis B vaccinated without infection
- History of allergy to investigational product components or contraindicating drug allergies
- Known primary immunodeficiency except asymptomatic selective IgA or IgG subclass deficiency
- Active or untreated latent tuberculosis
- History of anaphylaxis to biologic therapy
- Use of immunosuppressive medications within 3 months prior to first visit
- Recent receipt of immunoglobulin, blood products, investigational agents, or biologics within specified timeframes prior to first visit
- Pregnant, breastfeeding, or lactating females
- History of chronic alcohol or drug abuse within 12 months prior to first visit
- Planned surgeries requiring general anesthesia or inpatient status over 1 day during study
- Unwillingness or inability to follow study procedures
- Enrollment in another investigational treatment clinical study
- Receipt of live or attenuated vaccines within 15 days prior to first visit
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 20 weeks
Participants receive subcutaneous injections of tezepelumab or placebo over a 20-week period to evaluate effects on airway inflammation.
5 visits (in-person) at 4-week intervals for injections
Trial Site Locations
Total: 2 locations
1
Research site
Copenhagen, Denmark, 2400
Actively Recruiting
2
Research site
Leicester, United Kingdom, LE3 9QP
Actively Recruiting
Research Team
K
Kristoffer Norheim, PhD
A
Asger Sverrild, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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