The effect of blocking TSLP signalling on airway inflammation in patients with chronic obstructive pulmonary disease

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 21.1Level: LLTClassification code 10009032Term: Chronic obstructive lung diseaseSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2022-000179-38-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-08
• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1.Written informed consent
2.A diagnosis of COPD
3.= 10 packyears smoked (current or ex-smokers)
4.Age 40 years or older
5.Postbronchodilator FEV1 = 30% predicted (and = 1.0L) and < 80% predicted
6.Maintenance treatment with LAMA+LABA±ICS (stable dose) for at least 3 months prior to V1
7.=1 prednisolon and/or antibiotic treated exacerbation in the past 12 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

1.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.
2.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).
3.Current asthma
4.Lung volume reduction surgery for COPD
5.Exacerbation requiring oral corticosteroids or antibiotics (any dose for more than 3 days) 4 weeks prior to Visit 1 or during the run-in period
6.Any use of home oxygen therapy
7.Any clinically relevant abnormal findings in hematology or clinical chemistry (laboratory results from Visit 1), physical examination, vital signs during the screening, which in the opinion of the investigator, may put the subject at risk because of his/her participation in the study, or may influence the results of the study, or the subject’s ability to participate in the study
8.History of cancer:
Subjects who have had basal cell carcinoma or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1.
Subjects who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
9.Acute upper or lower respiratory infections requiring antibiotics or antiviral medications within 4 weeks prior to Visit 1 or during the screening period

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of tezepelumab on eosinophilic bronchial mucosal tissue inflammation;Secondary Objective: To evaluate the effect of tezepelumab on bronchial mucosal tissue inflammation;Primary end point(s): The primary endpoint in the trial will be change in eosinophil cell counts per mm2, expressed as ratio;Timepoint(s) of evaluation of this end point: Baseline to week-20

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The change, expressed as ratio, in inflammatory cell counts (including neutrophils, mast cells, CD4+, CD8+ and macrophages);Timepoint(s) of evaluation of this end point: baseline to week-20