A Phase II Randomized Double-blind Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    322
  • sponsor
    AstraZeneca
Updated on 24 June 2021
body mass index
antibiotics
corticosteroids
COPD
pulmonary disease
cough

Summary

This is a research study to determine the efficacy and safety of investigational drug MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and Chronic Bonchitis.

Description

Study D9180C00002 is a Phase II, randomised, double-blind, placebo-controlled, parallel group, proof of concept study to evaluate the efficacy and safety of MEDI3506 in adult participants with moderate to severe Chronic Obstructive Pulmonary Disease and Chronic Bonchitis.

Approximately 129 sites globally will participate in this study. Approximately 322 participants will be randomized to 2 treatment groups in a 1:1 ratio to receive MEDI3506 or placebo.

Details
Condition Chronic Obstructive Lung Disease, Chronic bronchitis, COPD (Chronic Obstructive Pulmonary Disease), chronic obstructive pulmonary disease, COPD, chronic obstructive pulmonary disease (copd)
Treatment Placebo, MEDI3506
Clinical Study IdentifierNCT04631016
SponsorAstraZeneca
Last Modified on24 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Provision of informed consent
Participant must be 40 to 75 years of age inclusive
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 < 0.70 and a post-BD FEV1 > 30% and < 80% predicted normal value
Participants who have a physician confirmed participant history of chronic bronchitis as defined as presence of cough and sputum on most days for 3 mos/yr in at least the 2 year period immediately prior
Participants who have an average BCSS score of 2 in cough and 2 in sputum domains assessed over 14 days
Participants who have a documented stable regimen of dual therapy or triple therapy for 3 months prior to enrolment; there should have been no change in treatment after the previous exacerbation prior to entering into the study. Where dual therapy consists of ICS + LABA or LABA + LAMA, and triple therapy consists of ICS + LABA + LAMA
Participants who have a documented history of 1 moderate or severe AECOPD requiring systemic corticosteroids and/or antibiotics for at least 3 days duration (or 1 injection of depot formulation), or hospitalization for reason of AECOPD in the previous 12 months
Body mass index within the range 19 to 35 kg/m2 (inclusive)
Female participants of childbearing potential, must have negative pregnancy tests
Male and female participants must follow protocol contraceptive guidance

Exclusion Criteria

Participants with a positive diagnostic nucleic acid test for SARS-CoV-2 at screening
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
Predominant emphysema
Asthma as a current or past diagnosis
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
N-terminal pro-brain natriuretic peptide level greater than the upper limit of the laboratory reference range
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
Participants with a recent history of, or who have a positive test for, infective hepatitis or unexplained jaundice, or participants who have been treated for hepatitis B, hepatitis C, or 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
Additional inclusion and exclusion criteria's applies
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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