Chronic obstructive pulmonary disease and Sputum Eosinophilia MedDRA version: 13.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: MEDI-563
Product Code: MEDI-563
Pharmaceutical Form: Powder for solution for injection
CAS Number: 1044511-01-4
Current Sp
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 40 to 85 years old at the time of screening. 2. Written informed consent obtained from the subject prior to performing any protocol-related procedures. 3. Documented history of moderate to severe COPD with a post-bronchodilator FEV1/FVC 23 IU/L according to a central laboratory. 11. Sterilized males must be at least 1-year post vasectomy or must use adequate contraception if less than 1 year post vasectomy. 12. Ability and willingness to complete follow-up period as required by the protocol. 13. Subjects receiving allergy immunotherapy must be on a stable dose for the preceding 90 days prior to Day 1. 14. Able to read and write. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any condition that would interfere with evaluation of the investigational product or interpretation of subject safety or study results 2. Significant or unstable ischemic heart disease, arrhythmia, cardiomyopathy, heart failure, renal failure, uncontrolled hypertension as defined by Investigator or any other relevant cardiovascular disorder as judged by Investigator 3. Pregnant, breastfeeding or lactating women 4. Known history of allergy/reaction to any component of the investigational product formulation, budesonide/formoterol preparations, tiotropium bromide or terbutaline sulphate or any of their excipients 5. History of anaphylaxis to any other biologic therapy 6. Donation or transfusion of blood, plasma or platelets within past 90 Days prior to screening 7. Other significant pulmonary disease as a primary diagnosis if a subject is diagnosed with any other pulmonary diseases as a secondary diagnosis they may be included if, in the opinion of the investigator/medical monitor, the inclusion does not compromise the interpretation of the study 8. Receiving long-term oxygen therapy (LTOT) at entry into the study. LTOT is defined as use of oxygen for a min. of 15 hrs per day 9. Subjects who have past or present disease or disorder, which is judged by the investigator and the medical monitor, may either put the subject at risk because of participation in the study, or may affect outcome of the study. Subjects who have epilepsy must be on a stable dose of medication for 30 days prior to Day 1 10. Influenza vaccination within 3 wks before sputum collection at screening (Day -56) 11. Fever >37.8 °C (>100°F) measured using the tympanic temperature (or equiv. oral/rectal/axillary temperature) at Day 1 12. Use of immunosuppressive medication, including inhaled (other than Symbicort®), topical, ocular, nasal or rectal corticosteroids & systemic steroids within 28 days before randomization (Day 1) into the study 13. Receipt of immunoglobulin or blood products within 30 days before randomization into the study 14. Receipt of any novel investigational medicinal products within 3 months before the first dose of investigational product in this study and through to study end. 15. Seropositive for hepatitis B surface antigen, hepatitis C, or human immunodeficiency virus (HIV)-1 or HIV-2) 16. Unexplained diarrhea within 30 days prior to screening; or diagnosis of helminth parasitic infestation within 6 months prior to screening; history of untreated systemic helminth parasitic infection; history of living with person known to have had a helminth parasitic infestation within 12 months prior to screening; history of recent travel to areas where parasite infestations are endemic within 3 months before screening 17. Any subjects that have positive serum serology during screening/run-in period to Strongyloides stercoralis will be excluded. Subjects with positive serology to Schistosoma mansoni, Taenia solium, or Ascaris lumbricoides will undergo a confirmatory stool sampling per local guidelines1. If stool sampling is positive for Schistosoma mansoni or Taenia solium the subject will be excluded. All s
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary objective of this study is to evaluate the effect of multiple SC doses of MEDI-563 on the rate of moderate-to-severe AECOPD in adult subjects with moderate-to-severe COPD. The primary endpoint will be the number of moderate-to-severe AECOPD experienced by subjects after their first dose of investigational product to their Day 393/Early Discontinuation visit. ;Main Objective: The primary objective of this study is to evaluate the effect of multiple subcutaneous (SC) doses of MEDI-563 on the rate of moderate-to-severe acute axacerbations in Chronic Obstructive Pulmonary Disease (AECOPD) in adult subjects with moderate-to-severe COPD who exhibit eosinophilia (equal to or greater than 3% sputum eosinophilia in the previous 12 months or at screening) compared to placebo.; Secondary Objective: The secondary objectives of this study are: 1. To evaluate the safety and tolerability of MEDI-563 in this subject population. 2. To evaluate the reduction in hospitalization due to AECOPD. 3. To assess the effect of MEDI-563 on health-related quality of life measurements such as the Chronic Obstructive Pulmonary Disease-specific Saint George's Respiratory Questionnnaire (SGRQ-C) and the Chronic Respiratory Questionnaire self-administered standardized format (CRQ-SAS). 4. To describe the effect of MEDI-563 on the BODE (Body Mass Index, Airway Obstruction, Dyspnea, and exercise capacity) index | — |
Countries
Denmark, Germany, Spain, United Kingdom
Outcome results
None listed