Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis MedDRA version: 21.1 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: MEDI3506
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Not available
CAS Number: 2376858-66-9
Current Sponsor code: MEDI3506
Other descriptive name: human immunoglobul
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Provision of informed consent • Participant must be 40 to 80 years of age inclusive, at the time of signing the ICF. • Participants who are current or ex-smokers with a tobacco history of = 10 pack-years. • Participants who have a documented history of COPD for at least 1 year. • Participants who have a post-BD FEV1/FVC 20% and =65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria
Exclusion criteria: • Participants with a positive diagnostic nucleic acid test for SARS-CoV-2 at screening. Subjects with mild or asymptomatic disease could be rescreened. • Participants with a significant COVID-19 illness within 6 months of enrolment • As judged by the investigator, any evidence of any active medical or psychiatric condition or other reason which in the investigator's opinion makes it undesirable for the participant to participate in the study. • Asthma as a current or as a past diagnosis unresolved by age 25 • Clinically important pulmonary disease other than COPD, radiological findings, and/or laboratory findings suggestive of a respiratory disease other than COPD that is contributing to the participant's respiratory symptoms. • Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1 of = 400 mL or = 25% of SV1 FEV1. • Any other clinically relevant abnormal findings on physical examination, laboratory testing; or chest CT scan, which in the opinion of the investigator or medical monitor may compromise the safety of the participant in the study or interfere with evaluation of the study intervention or reduce the participant's ability to participate in the study. • A family history of heart failure. • A LVEF < 45% measured by echocardiogram. • History of a clinically significant infection (viral, bacterial, or fungal) within 4 weeks. • History of, or a reason to believe a participant has a history of, drug or alcohol abuse within the past 2 years prior to screening. • Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening • A positive test for HIV and known to have tested positive for HIV. • Evidence of active or untreated latent TB. • Change in smoking status in 12 weeks prior to enrolment or intention to change smoking status between enrolment and end of follow-up. • Participants currently receiving background therapy that is not approved by regulatory authorities in the country of study for COPD are not eligible for the study. • History of treatment with cardiotoxic medications (eg, as part of cancer therapy) including thiazolidinediones. • Treatment with broad spectrum antibiotic within 4 weeks prior to randomization (Day 1). • Receiving any of the prohibited concomitant medications as specified in the CSP. • Inability to perform technically acceptable spirometry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effects of MEDI3506 compared with placebo on pulmonary function in participants with COPD and chronic bronchitis.;Secondary Objective: 1. To assess the PK of MEDI3506 in participants with COPD and chronic bronchitis. 2. To assess the immunogenicity of MEDI3506 compared with placebo in participants with COPD and chronic bronchitis. 3. To assess the effect of MEDI3506 on COPDCompEx event in participants with COPD and chronic bronchitis 4. To assess the effect of MEDI3506 compared with placebo on respiratory symptoms in participants with COPD and chronic bronchitis. 5. To assess the effect of MEDI3506 compared with placebo on disease impact in participants with COPD and chronic bronchitis. 6. To assess the effect of MEDI3506 compared with placebo on airway resistance and reactance in participants with COPD and chronic bronchitis. 7. To evaluate the effect of MEDI3506 compared with placebo on objective cough measures in participants with COPD and chronic bronchitis. 8. To evaluate the effect of MEDI3506 or placebo on lung function by extent of baseline emphysema on CT scan;Primary end point(s): Change from baseline to Week 12 in pre BD FEV1 measured in clinic.;Timepoint(s) of evaluation of this end point: Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Serum MEDI3506 concentration-time profiles during the intervention and follow-up periods. 2. Anti-drug antibodies during the intervention and follow-up periods. 3. Time to first COPDCompEx event based on the period from baseline to 4 weeks after last dose (Week 28) 4. Change from baseline to Week 12 in: • E-RS:COPD • Mean BCSS score (over the previous 4 weeks) • Cough VAS item 5. • Change from baseline to Week 12 in SGRQ total score • Proportion of participants with a decrease in SGRQ total score of = 4 points from baseline to Week 12 6. Change from baseline to Week 12 in Airway Oscillometry parameters: • R5-R20 • R5 • R20 • AX 7. At Week 12, ratio to baseline in: • Daily (ie, 24 hour) cough frequency • Night time cough frequency • Awake time cough frequency 8. • Change from baseline in pre-BD and post-BD FEV1 through Week 28 • Change from baseline in pre-BD and post BD FVC through Week 28;Timepoint(s) of evaluation of this end point: 1. Serum MEDI3506 concentration - During the intervention and follow-up periods 2. Anti-drug antibodies - During the intervention and follow-up periods 3. COPDCompEx - Week 28 4. E-RS:COPD, Mean BCSS score (over the previous 4 weeks) and Cough VAS item - Week 12 5. SGRQ - Week 12 6. AO parameters - Week 12 7. Cough frequency - Week 12 8. Pre-BD and post-BD FEV1 and FVC - Week 28 | — |
Countries
Australia, Canada, Czechia, Czech Republic, Denmark, Germany, Hungary, Israel, Netherlands, New Zealand, Poland, South Africa, Spain, United Kingdom, United States
Contacts
Public ContactInformation Center
AstraZeneca AB
Outcome results
None listed