Functional Respiratory Imaging Study (DARWiIN)

Chiesi

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium

Study type: Interventional

Funder types: Industry

Identifiers

NCT04876677

CLI-05993BA1-08

Details and patient eligibility

About

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

Enrollment: 25 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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;

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

CHF5993

Experimental group

Description:

Beclometasone Dipropionate (BDP) 100 μg/inhalation + Formoterol Fumarate (FF) 6 μg/inhalation + Glycopyrronium Bromide (GB) 12.5 µg/inhalation

Treatment:

Drug: Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium