Efficacy and Safety of MEDI3506 in Symptomatic Chronic Obstructive Pulmonary Disease with a History of Exacerbations
- Conditions
- Health Condition 1: J449- Chronic obstructive pulmonary disease, unspecified
- Registration Number
- CTRI/2022/03/040954
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1 Participant must be = 40 years of age at the time of signing the ICF.
2 Documented diagnosis of COPD for at least one year prior to enrolment.
3 Post-BD FEV1/FVC < 0.70 and post-BD FEV1 >20% of predicted normal value (as
assessed by central spirometry at screening).
4 Documented history of = 2 moderate or = 1 severe COPD exacerbations within 12 months prior to enrolment:
(a) An exacerbation is considered moderate if it required treatment with systemic
corticosteroids and/or antibiotics, and severe if it required hospitalization. Note:
hospitalization is defined as an inpatient admission = 24 hours in the hospital, in an
observation area, emergency department, or other equivalent healthcare facility
depending on the country and healthcare system.
(b) At least one qualifying exacerbation should have been treated with systemic
corticosteroids.
(c) Events treated with antibiotics alone qualify as a moderate exacerbation only when
antibiotic was specifically prescribed for worsening of COPD symptoms.
(d) Previous exacerbations should be confirmed to have occurred while the participant
was on stable dual or triple (ICS/LABA/LAMA) maintenance inhaled therapy for
COPD and not as a result of a gap or step down in the treatment.
(e) At least one qualifying exacerbation should have occurred while on the most recent stable uninterrupted therapy prior to enrolment.
5. Documented optimised treatment with COPD inhaled maintenance therapy
(ICS/LABA/LAMA triple therapy, or dual therapy if triple is not indicated or
contraindicated) and at a stable dose for at least 3 months prior to enrolment. During this period:
(a) Individual component changes or switches between devices are allowed as long as
the participant remains on the same class therapies in equivalent doses
(b) Short-term changes in background treatment regimen during COPD exacerbation are acceptable.
(c) Short-acting muscarinic antagonist taken at regular scheduled interval (at a minimum frequency of 3 times daily) will be considered equivalent to LAMA.
(d) If participant is being treated with any oral COPD maintenance therapy (eg,
macrolides, xanthines, roflumilast), these treatments must also be stable for at least 3
months prior to enrolment.
6 Smoking history of = 10 pack-years:
(a) Former smokers will be defined as participants who are currently not smoking and
with smoking cessation = 6 months prior to screening with an intention to quit
permanently.
(b) Current smokers will be defined as participants who are currently smoking tobacco
(at least one cigarette per day on average during the past 7 days) and are not currently
participating in smoking cessation.
(c) Electronic cigarette (e-cigarette) use does not contribute to the pack-year count for
eligibility.
7 CAT total score = 10, with each of the phlegm (sputum) and cough items with a score = 2, at both screening (V1) and randomisation (V2).
8 At least 70% daily PRO completion during the entire screening period, with at least 50% daily PRO completion in the 14-day period prior to randomisation.
9 At least 70% compliance with COPD maintenance inhaled therapy (defined as taking COPD maintenance inhaled medication as scheduled for the day)
1. Clinically important pulmonary disease other than COPD (eg, 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).
2. Radiological findings suggestive of a respiratory disease other than COPD that is
contributing to the participant s respiratory symptoms. Radiological findings of solitary
pulmonary nodules without appropriate follow up and demonstration of stability as per
standard of care, or findings suggestive of acute infection.
3 Current diagnosis of asthma according to the GINA or other accepted guidelines, prior
history of asthma, or asthma-COPD overlap 3. Childhood history of asthma is allowed and defined as asthma diagnosed and resolved (ie, not requiring the use of any maintenance or rescue medication) before the age of 18.
4 Any unstable disorder, including, but not limited to, cardiovascular, gastrointestinal,
hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic,
haematological, psychiatric disorder, major physical and/or cognitive impairment that, in the opinion of the investigator, could:
(a) Affect the safety of the participant throughout the study.
(b) Influence the findings of the study or their interpretation.
(c) Impede the participant s ability to complete the entire duration of the study and/or
comply with the study visit schedule and procedures.
5 COPD exacerbation, within 2 weeks prior to randomisation, that was treated with
systemic corticosteroids and/or antibiotics, and/or led to hospitalisation (based on last
dose of corticosteroids or antibiotics, or last date of hospitalisation, whichever occurred
later).
6 Active significant infection (viral, bacterial, or fungal infections requiring treatment with systemic antibiotic, antiviral, or antifungal medication, respectively) within the 4 weeks prior to randomisation, pneumonia within 6 weeks prior to randomisation, or medical condition that predisposes the participant to infection.
7 Suspicion of, or confirmed, ongoing SARS-CoV-2 infection.
8 Significant COVID-19 illness within the 6 months prior to enrolment, defined as:
(a) A diagnosis of COVID-19 pneumonia based on radiological assessment.
(b) A diagnosis of COVID-19 with significant new findings from pulmonary imaging
tests.
(c) A diagnosis of COVID-19 requiring hospitalisation and/or oxygen supplementation
therapy.
9 Unstable cardiovascular disorder (including but not limited to: ischaemic heart disease, arrhythmia, cardiomyopathy, unstable moderate to severe heart failure (NYHA class III-IV and or LVEF < 30%), clinically significant aortic stenosis, uncontrolled arterial hypertension, or any other relevant cardiovascular condition), that, in the investigator s judgement may put the participant at risk or negatively affect the outcome of the study.
10. Diagnosis of cor pulmonale, pulmonary arterial hypertension and/or right ventricular failure.
11 History of active severe inflammatory bowel disease or colitis within one year prior to enrolment, or unexplained diarrhoea within the 4 weeks prior to randomisation.
12 History of known immunodeficiency disorder, including a positive test for H
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method