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Effects of Blocking TSLP on Airway Inflammation and the Epithelial Immune-response to Exacerbation Triggers in Patients With COPD

ConditionsCOPDCOPD ExacerbationCOPD BronchitisAirway DiseaseImmune System Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorAsger Sverrild

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent

A diagnosis of COPD (according to GOLD (GOLD 2021 Report))

≥ 10 packyears smoked (current or ex-smokers)

Age 40 years or older

Disqualifiers

Previous medical history or evidence of an uncontrolled intercurrent illness that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the investigational product or reduce the subject's ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to Visit 1 are eligible.

Any concomitant respiratory disease that in the opinion of the investigator will interfere with the evaluation of the investigational product or interpretation of subject safety or study results (e.g., cystic fibrosis, pulmonary fibrosis, aspergillosis, active tuberculosis).

Current asthma

Lung volume reduction surgery for COPD

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tezepelumab

    Biological/Vaccine

    Tezepelumab 210 mg for 20 weeks (5 doses in total, 4-week intervals), administered subcutaneously

  • Placebo

    Other intervention

    Placebo subcutaneous injection for 20 weeks (5 doses in total, 4-week intervals)

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: TezepelumabExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation

The change, expressed as ratio, in eosinophil cell counts per mm2 from baseline to week-20

Time frame
20 weeks

Secondary outcomes

1

To evaluate the effect of tezepelumab on neutrophilic bronchial mucosal tissue inflammation

The change, expressed as ratio, in neutrophil cell couts per mm2 from baseline to week-20

Time frame
20 weeks
2

To evaluate the effect of tezepelumab on mast cell bronchial mucosal tissue inflammation

The change, expressed as ratio, in mast cell couts per mm2 from baseline to week-20

Time frame
20 weeks
3

To evaluate the effect of tezepelumab on CD4+ cell bronchial mucosal tissue inflammation

The change, expressed as ratio, in CD4+ cell couts per mm2 from baseline to week-20

Time frame
20 weeks
4

To evaluate the effect of tezepelumab on CD8+ cell bronchial mucosal tissue inflammation

The change, expressed as ratio, in CD8+ cell couts per mm2 from baseline to week-20

Time frame
20 weeks

Other outcomes

Sponsors and contacts

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Asger Sverrild

Lead sponsor

Bispebjerg Hospital

Sponsor institution

AstraZeneca

Collaborator

University Hospitals, Leicester

Collaborator

Source ClinicalTrials.gov
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