J441 Chronic obstructive pulmonary disease with acute exacerbation, unspecified Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Conditions
Interventions
Tezepelumab 210mg, SC, Q4W - Tezepelumab 420 mg, SC, Q4W Placebo, SC, Q4W
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 2. Documented physician-diagnosed COPD for at least 12 months before Visit 1. 3. A post-BD FEV1/FVC < 0.70 and a post-BD FEV1 = 20% and = 70% of the predicted normal value during screening. 1. Age 1 Adult participants 40 to 80 years of age at the time of signing the informed consent. 4. Documented regular dose of triple (ICS+LABA+LAMA) or dual (LABA+LAMA, ICS+LABA, ICS+LAMA) inhaled therapy for at least 3 consecutive months before Visit 1. 5. Antecedentes documentados de = 2 exacerbaciones moderadas o = 1 severa de la EPOC dentro de los 12 meses anteriores a la Visita 1. Por lo menos una de las dos exacerbaciones moderadas debe haber sido tratada con corticosteroides sistemicos. 6. EOS = 150 cells/µL during the screening period. 7. CAT total score = 15 at Visit 1. 10. Current or former smokers (with smoking cessation = 6 months before Visit 1) have a history of at least 10 pack-years of tobacco smoking (1 pack year = 20 cigarettes smoked per day for 1 year). 9. Body weight = 40 kg at Visit 1 10. Participants not of childbearing potential are defined as participants who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age-specific requirements apply: - Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range. - Women = 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. 11. Capable of giving signed informed consent as described in Appendix A 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. 12. Provision of signed and dated, written ICF prior to any mandatory study-specific procedures, sampling, or analysis. 13. Provision of signed and dated written Optional Genomics Initiative Research Information and Consent Form prior to collection of samples for optional genomics initiative research that supports the Genomic Initiative (see Appendix D 2). 14. = 70% compliance with participant’s maintenance COPD therapy within 2 weeks immediately before Visit 2
Exclusion criteria
Exclusion criteria: 33. Non-leukocyte-depleted whole blood transfusion within 120 days of genetic sample collection. 34. Previous allogenic bone marrow transplant 35. 35 Pregnant (confirmed with positive pregnancy test), breastfeeding, or lactating participants 36. Taking part in, or are scheduled for, an intensive (active) COPD rehabilitation programme (however participants who are in the maintenance phase of a rehabilitation programme are eligible to take part). 37. Inability to follow the study procedures or restrictions, in the opinion of the investigator (eg, use of ePRO device or app, unacceptable inhaler techniques, and spirometry techniques according to the ATS/ERS 2019 guidelines (Graham et al 2019)). 38. Donation of blood, plasma, or platelets within the past 90 days before randomisation. 1. Clinically important pulmonary disease other than COPD (eg, active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, cystic fibrosis, hypoventilation syndrome associated with obesity, lung cancer, alpha 1 anti-trypsin deficiency and primary ciliary dyskinesia) or another diagnosed pulmonary or systemic disease that is associated with elevated peripheral EOS (eg, allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome). 2. Radiological findings suggestive of a respiratory disease other than COPD that is significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer, as per applicable guidance, (eg, ACR Lung-RADS v2022, (Christensen et al 2024)) without appropriate follow up before Visit 2. 3. Radiological findings suggestive of acute infection. 4. Current physician diagnosed asthma according to the Global Initiative for Asthma (GINA 2024 and onwards versions) guidelines or other accepted guidelines, past physician diagnosed asthma including paediatric asthma, or asthma-COPD overlap syndrome. 5. Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immune, psychiatric, or major physical/or cognitive impairment that is not stable in the opinion of the investigator or the sponsor and/or could: - Affect the safety of the participant throughout the study - Influence the findings of the study or their interpretation - Impede the participant’s ability to complete the entire duration of the study and/or comply with the study visit schedule and procedures. 6. Unstable cardiovascular disorder (including but not limited to ischemic heart disease, arrhythmia, cardiomyopathy, severe right and/or left heart failure (NYHA class IV)), renal failure, uncontrolled hypertension, as defined by the Investigator, or any other relevant cardiovascular disorder or ECG abnormality that in the Investigator’s judgment may put the participant at risk or negatively affect the outcome of the study. 7. Acute upper or lower respiratory infection requiring antibiotics or systemic antiviral medication within 2 weeks before Visit 1 (based on the last day of antibiotic/antiviral treatment, whichever occurred later). Lower respiratory infection requiring hospitalisation less than 4 weeks before Visit 1 (based on the date of discharge from hospital). 8. COPD exacerbation treated with SCS and/or antibiotics within 2 weeks before Visit 1 (based on the last dose of corticosteroids or antibiotics, whichever
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised rate of moderate or severe COPD exacerbations up to 76 weeks NAME OF THE RESULT: the effect of tezepelumab with placebo on moderate or severe COPD exacerbations in participants with moderate to very severe COPD PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 76 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the SGRQ total score over 52 weeks NAME OF THE RESULT: the effect of tezepelumab with placebo on HRQL in participants with moderate to very severe COPD PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 52 weeks ;Change from baseline in the SGRQ total score over 52 weeks NAME OF THE RESULT: the effect of tezepelumab with placebo on HRQL in participants with moderate to very severe COPD PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 52 weeks ;Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants with screening EOS = 300 cells/µL NAME OF THE RESULT: The effect of tezepelumab with placebo on moderate or severe COPD exacerbations in participants with moderate to very severe COPD and screening EOS = 300 cells/µL PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 76 weeks ;Annualised rate of moderate or severe COPD exacerbations up to 76 weeks among participants with screening EOS = 300 cells/µL NAME OF THE RESULT: The effect of tezepelumab with placebo on severe COPD exacerbation PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 76 weeks ;Annualised rate of severe COPD exacerbations up to 76 weeks NAME OF THE RESULT: The effect of tezepelumab with placebo on severe COPD exacerbation PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 76 weeks ;Participants achieving a clinically meaningful improvement from baseline in SGRQ total score (4-point score decrease) over 52 weeks NAME OF THE RESULT: the effect of tezepelumab with placebo on HRQL in participants with moderate to very severe COPD PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 52 semanas ;Change from baseline in the CAT total sc | — |
Countries
Argentina, Australia, Belgium, Bulgaria, Colombia, Denmark, France, Greece, Hong Kong, Hungary, Israel, Japan, Nederland, New Zealand, Peru, Romania, South Africa, Sweden, Thailand, Turkey, United States, Vietnam
Contacts
Public ContactKelly Vasquez
ASTRAZENECA PERU S.A.
Outcome results
None listed