Functional Respiratory Imaging Study

Phase 3

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Drug: Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium

• Registration Number: NCT04876677
• Lead Sponsor: Chiesi Farmaceutici S.p.A.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-03
• Study First Submitted QC: 2021-05-03
• Study First Posted: 2021-05-06
• Study Start: 2021-05-25
• Status Verified: 2022-01
• Primary Completion: 2022-01-03
• Study Completion: 2022-01-03
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHF5993	Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium	Beclometasone Dipropionate (BDP) 100 μg/inhalation + Formoterol Fumarate (FF) 6 μg/inhalation + Glycopyrronium Bromide (GB) 12.5 µg/inhalation

Primary Outcome Measures

Name	Time	Method
specific airway volume (siVaw) upon inspiration	change from baseline at 6 weeks	CT-based airway volumes
specific airway resistance (siRaw) upon inspiration	change from baseline at 6 weeks	CT-based airway volumes

Secondary Outcome Measures

Name	Time	Method
perfusion mapping	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
siVaw upon expiration	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
siRaw upon expiration	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
airway wall thickness upon inspiration	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
ventilation mapping	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
imaged lobe and lung volumes at Total Lung Capacity (TLC) and Functional Residual Capacity (FRC)	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
air trapping	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
low attenuation score at TLC	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
Percentile 15th at TLC	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography
regional lung deposition	change from baseline at 6 weeks	calculated using Multidetector Computed Tomography

Trial Locations

Locations (8)

AZ Zeno Knokke-Heist; 🇧🇪 Knokke, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium

CRU Hungary Ltd; 🇭🇺 Miskolc, Hungary

Dr. Kenessey Albert Hospital; 🇭🇺 Balassagyarmat, Hungary

National Koranyi Institute for TB and Pulmonology; 🇭🇺 Budapest, Hungary

Centre medical Erpent - Residence; 🇧🇪 Erpent, Belgium

OLV Hospital Aalst; 🇧🇪 Aalst, Belgium

Heilige Familie AZ; 🇧🇪 Reet, Belgium