Actively Recruiting
Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD
Led by Asger Sverrild · Updated on 2024-08-21
80
Participants Needed
2
Research Sites
166 weeks
Total Duration
On this page
Sponsors
A
Asger Sverrild
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
A phase 2, multicentre, randomized, double-blind, placebo-controlled, parallel group study to evaluate the effect of tezepelumab on airway inflammation in patients with COPD.
CONDITIONS
Official 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 guidelines
- Age 40 years or older
- Smoking history of 10 or more pack-years (current or former smoker)
- Postbronchodilator FEV1 between 30% and less than 80% predicted, and at least 1.0 L
- Stable maintenance treatment with LAMA plus LABA with or without ICS for at least 3 months before screening
- At least one prednisolone and/or antibiotic treated exacerbation in the past 12 months
- Able to demonstrate acceptable inhaler and spirometry techniques
- At least 70% compliance with daily inhaler use during screening/run-in
- Females of childbearing potential using effective contraception during the study period
You will not qualify if you...
- Uncontrolled intercurrent illness that may affect safety or study evaluation
- Other respiratory diseases interfering with study evaluation (e.g., cystic fibrosis, pulmonary fibrosis, aspergillosis, active tuberculosis)
- Current asthma diagnosis
- Lung volume reduction surgery for COPD
- Exacerbation requiring oral corticosteroids or antibiotics more than 3 days within 4 weeks prior to screening or during run-in
- Use of home oxygen therapy
- Clinically relevant abnormal lab or physical exam findings posing risk or affecting participation
- History of cancer except basal cell carcinoma or in situ cervical carcinoma treated at least 12 months prior, or other malignancies treated at least 5 years prior
- Recent acute respiratory infections requiring antibiotics or antivirals within 4 weeks prior to screening
- Positive HIV test or use of antiretroviral medications
- Positive hepatitis B or C serology or history (except vaccination without infection)
- History of sensitivity or allergy contraindicating participation
- Known primary immunodeficiency disorders (except selective IgA or IgG subclass deficiency)
- Active or untreated latent tuberculosis
- History of anaphylaxis to biologic therapies
- Use of immunosuppressive medications within 3 months prior to screening
- Receipt of immunoglobulin, blood products, or investigational agents within specified timeframes before screening
- Pregnant, breastfeeding, or lactating females
- History of chronic alcohol or drug abuse within 12 months prior to screening
- Planned surgeries requiring general anesthesia or inpatient stay longer than 1 day during the study
- Inability or unwillingness to comply with study procedures
- Concurrent enrollment in another clinical trial with investigational treatment
- Receipt of live or attenuated vaccines within 15 days prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Asger Sverrild, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here