Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 21.1 Level: LLT Classification code 10009032 Term: Chronic obstructive lung disease System Organ Class: 100000004855
Conditions
Interventions
Product Name: tezepelumab
Product Code: MEDI9929
Pharmaceutical Form: Solution for injection in vial
INN or Proposed INN: TEZEPELUMAB
Other descriptive name: MEDI9929
Concentration unit: mg/ml milligr
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Denmark, United Kingdom
Contacts
Public ContactRespiratory Research Unit
Bispebjerg Hospital
Outcome results
None listed