A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy, Safety and Tolerability of MEDI3506 in Participants with Moderate to Severe Chronic Obstructive Pulmonary Disease and Chronic Bronchitis
- Conditions
- (Chronic Obstructive Pulmonary Disease) and Chronic BronchitisCOPD10024967
- Registration Number
- NL-OMON55071
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 31
1. Participant must be 40 to 75 years of age inclusive, at the time of signing
the ICF.
2. Participants who are current or ex-smokers with a tobacco history of * 10
pack-years.
3. Participants who are up-to-date on pneumococcus and influenza vaccines as
per local
treatment guidelines.
4. Participants who have a documented history of COPD for at least 1 year.
5. Participants who have a post-BD FEV1/FVC < 0.70 and a post-BD FEV1 > 30% and
< 80% predicted normal value at screening.
6. 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 to SV1 (screening).
7. Participants who have an average BCSS score of * 2 in cough and * 2 in
sputum domains
assessed over the 14 days preceding SV3.
8. Participants who have a documented stable regimen of dual therapy (ICS +
LABA or LABA + LAMA) or triple therapy (ICS + LABA + LAMA) for * 3 months prior
to enrolment; there should have been no change in treatment after the previous
exacerbation prior to entering into the study.
9. 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 24 months prior to screening. A verbal history from
the participant of AECOPD is not sufficient.
10. Participants who are clinically stable and free from an exacerbation of
COPD for 1 month prior to SV1 (screening) and prior to Day 1.
1. Participants with a positive diagnostic nucleic acid test for SARS-CoV-2 at
SV1 or SV2.
2. Participants with a significant COVID-19 illness within 6 months of
enrolment
3. As judged by the investigator, any evidence of any active medical or
psychiatric condition or other reason (at screening [SV1 and SV2] and SV3
[pre-dose]). See exclusion criteria number 3 in the protocol.
4. Asthma as a current or past diagnosis.
5. Clinically important pulmonary disease other than COPD (
6. Increased pre-BD FEV1 at randomization visit (SV3) compared to Screening SV1
of * 400 mL or * 25% of SV1 FEV1.
7. A family history of heart failure defined as either of the following: * 2
first degree relatives with clinically significant heart failure, or * 1 first
degree relative with heart failure known to be heritable (eg, hypertrophic
cardiomyopathy), unless inheritance is excluded by genetic testing.
8. A LVEF < 45% measured by echocardiogram during screening, between the time
of signing informed consent and prior to randomization.
9. History of a clinically significant infection (viral, bacterial, or fungal)
within 4 weeks prior to Day 1 (SV3) (including unexplained diarrhea) or
clinical suspicion of infection at time of dosing.
10. Prior history of/planned: lung pneumonectomy for any reason, or lung
volume reduction procedures (including bronchoscopic volume reduction) for
COPD. Note: Surgical biopsy, or segmentectomy, or wedge resection, or lobectomy
for other diseases would not
be excluded.
11. Long term oxygen therapy.
12. Use of any non-invasive positive pressure ventilation device.
13. Participants with a recent history of, or who have a positive test for TB,
Hep B, Hep C or HIV.
14. Receiving any of the prohibited concomitant medications as specified in the
CSP.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To assess the effects of MEDI3506 compared with placebo on pulmonary function<br /><br>in participants with COPD and chronic bronchitis, the change from baseline to<br /><br>Week 12 in pre-BD FEV1 measured in clinic will be used as primary endpoint.</p><br>
- Secondary Outcome Measures
Name Time Method