Functional Respiratory Imaging Study (DARWiIN)

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease Read More

Inclusion Criteria:

1. Subject's signed Informed Consent Form;
2. Male or female ≥ 40 years of age;
3. Current smokers or ex-smokers of at least 10 pack-years,
4. Established diagnosis of COPD
5. Post-BD Forced Expiratory Volume in one second/Forced Vital Capacity (FEV1/FVC) < 0.7 and FEV1 ≤ 60% of predicted at V1
6. On a stable dose any non-extra fine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
7. Presence of lung hyperinflation
8. Symptomatic subjects with COPD assessment test (CAT) score ≥ 10;
9. Documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months

Exclusion Criteria:

1. Pregnant or lactating woman;
2. Exacerbations defined as a sustained and acute deterioration of subject's symptoms and signs 30 days before screening;
3. A current asthma diagnosis;
4. Respiratory disorders other than COPD:
5. Cardiovascular diseases;
6. Evidence or history of other concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease;
7. Medical history or current diagnosis of narrow-angle glaucoma;
8. History of lung transplant or lung reduction surgery;
9. ECG criteria: any clinically significant abnormal 12-lead ECG that in the investigator's opinion would affect efficacy or safety evaluation or place the subjects at risk;
10. Laboratory abnormalities;
11. Alcohol/drug abuse;
12. Contra-indications to Investigational medical products (IMPs), based on investigator judgement;
13. Documented Covid-19 diagnosis or its complications which have not resolved within 14 days prior to screening;

15. Positive molecular Covid-19 test within the last 72 hours before the remaining of screening activities.