Functional Respiratory Imaging Study

• Status: Recruiting
• Trial end date: 2022-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the stepping-up effect from a double ICS/LABA DPI therapy to a triple DPI therapy on airway geometry and lung ventilation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Beclomethasone; Formoterol Fumarate; Glycopyrrolate

Criteria

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.