A Research Study Looking at Tozorakimab or Placebo in People with Chronic Obstructive Pulmonary Disease (COPD)
- Conditions
- Health Condition 1: J981- Pulmonary collapse
- Registration Number
- CTRI/2024/02/063113
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1 Documented diagnosis of COPD for at least one year prior to enrolment.
2 Post BD FEV1/FVC < 0.70 and post-BD FEV1 > 20% of PNV (as assessed by central spirometry at screening).
3 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 or resulted in ER visit < 24 hours requiring intensive treatment; and did not result in hospitalisation or death. An exacerbation is considered severe if it required hospitalisation (defined as an in-patient admission = 24 hours in the hospital, in an observation area, ED, 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.
4 Documented optimised treatment with COPD inhaled maintenance therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) 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 oral COPD maintenance therapy (macrolides, roflumilast), these treatments must also be stable for at least 3 months prior to enrolment.
5 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.
6 CAT total score = 10, with each of the phlegm (sputum) and cough items with a score = 2 at Screening (V1), and CAT total score = 10 at Randomisation (V2).
7 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.
8 At least 70% compliance with COPD maintenance inhaled therapy (defined as taking COPD maintenance inhaled medication as scheduled for the day) during the entire screening period.
9 Able to read and use a handheld electronic device.
Sex and Contraceptive/Barrier Requirements
10 Female participa
Medical Conditions
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 significantly contributing to the participant’s respiratory symptoms. Radiological findings of pulmonary nodules suspicious for lung cancer (as per applicable guidances, eg, ACR LUNG-RADS v2022 [ACR 2022]) without appropriate follow-up prior to randomisation. Radiological 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 . 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 years.
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 Chronic Obstructive Pulmonary Disease 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, includin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the effect Q2W dose regimen of tozorakimab as add-on to SoC compared with SoC plus placebo on the rate of moderate-to-severe COPD exacerbations in former smokers.Timepoint: Endpoint: annualised rate of moderate-to-severe COPD exacerbations over 52 weeks. <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method