Add on treatment for COPD for patients who experience frequent exacerbations

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Updated on 9 June 2022


Current or former smokers who are diagnosed with COPD and experienced at least 2 exacerbations- worsening of symptoms requiring steroid treatment or hospitalization despite being on multiple inhaler medications may qualify for this study involving benralizumab subcutaneous injections compared to placebo injections, initially every 4 weeks, then every 8 weeks after the third dose. 


Study Medication: Benralizumab 100 mg subcutaneous injection every 4 weeks for the first 3 doses, then every 8 weeks
Comparator: Placebo subcutaneous injection every 4 weeks for the first 3 doses, then every 8 weeks
Ratio: 1:1
Length of Study: Screening Period up to 13 weeks, Double-Blind Portion up to 56 weeks, followed by end of study visit
Visits: approximately 18 over 60 weeks
Key Study Procedures: Spirometry, Physical Exam, bloodwork, Vitals, Diary, Questionnaires, Chest X-Ray
Compensation: $100.00/Visit completed

Condition COPD (Chronic Obstructive Pulmonary Disease)
Clinical Study IdentifierTX301778
Last Modified on9 June 2022


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Inclusion Criteria

Patient must be 40 to 85 years of age inclusive, at the time of signing the ICF
Current smoker or ex-smoker with a tobacco history of ≥10 pack-years (1 pack-year = 20 cigarettes smoked per day for 1 year). (Note: electronic cigarette [e-cigarette] use does not contribute to the pack-year count for eligibility.)
History of moderate to very severe COPD
Documented history of 2 or more moderate and/or severe COPD exacerbations12 that required treatment with systemic corticosteroids (at least 3 days or a single depot formulation injection) and/or hospitalization within 52 weeks prior to enrollment. Documented use of triple (ICS/LABA/LAMA3 ) background therapy for COPD for ≥3 months immediately prior to enrollment

Exclusion Criteria

Clinically important pulmonary disease other than COPD (e.g. 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)
Current diagnosis of asthma, according to the Global Initiative for Asthma (GINA) or other accepted guidelines, prior history of asthma, or asthma-COPD overlap according to GINA/GOLD1 Childhood history of asthma is allowed and defined as asthma diagnosed and resolved (i.e. not requiring the use of any maintenance or rescue medication) before the age of 18
Radiological findings suggestive of a respiratory disease other than COPD that is contributing to the patient’s respiratory symptoms. Radiological findings of solitary pulmonary nodules without appropriate follow up and demonstration of stability as per standard of care or results suggestive of acute infection
Another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts (e.g. allergic bronchopulmonary aspergillosis/mycosis, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome)
Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, hematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and/or could
\- Affect the safety of the patient throughout the study
\- Influence the findings of the study or their interpretation
\- Impede the patient’s ability to complete the entire duration of the study
Any clinically significant abnormal findings in physical examination, vital signs, ECG, hematology, clinical chemistry, or urinalysis during the run-in period, which in the opinion of the investigator may put the patient at risk because of his/her participation in the study, or may influence the results of the study, or the patient’s ability to complete the entire duration of the study
Signs and/or symptoms of cor pulmonale and/or right ventricular failure
Patients receiving long-term treatment with oxygen >4.0 liters/minute (L/min). While breathing supplemental oxygen, patients should demonstrate an oxyhemoglobin saturation ≥89%. In order to be admitted to the study, patients on long-term oxygen therapy have to
be ambulatory and be able to attend clinic visits
Use, or need for chronic use, of any non-invasive positive pressure ventilation device (NIPPV). Note: Patients using continuous positive airway pressure (CPAP) for Sleep Apnea Syndrome are allowed in the study
History of known immunodeficiency disorder including a positive test for human immunodeficiency virus, HIV-1 or HIV-2
Active liver disease. Chronic stable hepatitis B and C (including positive testing for hepatitis B surface antigen or hepatitis C antibody), or other stable chronic liver disease are acceptable if patient otherwise meets eligibility criteria. Stable chronic liver disease should generally be defined by the absence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice, or cirrhosis
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3 times the upper limit of normal (ULN), confirmed by repeated testing1 during the run-in period. Transient increase of AST/ALT level that resolves by the time of randomization is acceptable if, in the investigator’s opinion, the patient does not have an active liver disease and meets other eligibility criteria
A helminth parasitic infection diagnosed within 24 weeks prior to the date informed consent is obtained that has not been treated with or has failed to respond to standard of care therapy
History of alcohol or drug abuse within the past year, which may compromise the study data interpretation as judged by investigator or AZ study physician
Malignancy, current or within the past 5 years, except for adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma-in-situ treated with apparent success more than 1 year prior to Visit 1. Suspected malignancy or undefined neoplasms
Patients who, in the opinion of the investigator or qualified designee, have evidence of active TB. Patients with a recent (within 2 years) first-time or newly positive purified protein derivative (PPD) test or Quantiferon test need to complete an appropriate course of treatment before being considered for enrollment. Evaluation will be according to the local standard of care and may consist of history and physical examinations, chest X-ray, and/or TB test as determined by local guidelines
Patients participating in, or scheduled for, an intensive (active) COPD rehabilitation program (patients who are in the maintenance phase of a rehabilitation program are eligible to take part)
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