Functional Respiratory Imaging Study

Chronic Obstructive Pulmonary Disease Clinical Trial

— DARWiIN  

Official title:

Open Label, Prospective Study to Evaluate the Effect of Step-up From Non-extra Fine Inhaled Corticosteroids/Long Acting Beta2 Agonist (ICS/LABA) Dry Powder Inhaler (DPI) to Extra Fine Triple Therapy With CHF5993 DPI on Airway Geometry and Lung Ventilation Using Functional Respiratory Imaging (FRI) in Subjects With Advanced Chronic Obstructive Pulmonary Disease (COPD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04876677
• Other study ID #: CLI-05993BA1-08
• Status: Completed
• Phase: Phase 3
• Start date: May 25, 2021
• Est. completion date: January 3, 2022

Study information

• Verified date: January 2022
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: January 3, 2022
• Est. primary completion date: January 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium
Two inhalations bid: 4 inhalations; total daily dose of 400/24/50 µg BDP/FF/GB

Locations

Country	Name	City	State
Belgium	OLV Hospital Aalst	Aalst
Belgium	Centre medical Erpent - Residence	Erpent
Belgium	AZ Zeno Knokke-Heist	Knokke
Belgium	Heilige Familie AZ	Reet
Belgium	AZ Delta	Roeselare
Hungary	Dr. Kenessey Albert Hospital	Balassagyarmat
Hungary	National Koranyi Institute for TB and Pulmonology	Budapest
Hungary	CRU Hungary Ltd	Miskolc

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Belgium,  Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	specific airway volume (siVaw) upon inspiration	CT-based airway volumes	change from baseline at 6 weeks
Primary	specific airway resistance (siRaw) upon inspiration	CT-based airway volumes	change from baseline at 6 weeks
Secondary	siVaw upon expiration	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	siRaw upon expiration	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	ventilation mapping	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	perfusion mapping	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	airway wall thickness upon inspiration	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	imaged lobe and lung volumes at Total Lung Capacity (TLC) and Functional Residual Capacity (FRC)	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	air trapping	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	low attenuation score at TLC	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	Percentile 15th at TLC	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks
Secondary	regional lung deposition	calculated using Multidetector Computed Tomography	change from baseline at 6 weeks