Clinical trial NCT04876677: Functional Respiratory Imaging Study
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2021-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: specific airway volume (siVaw) upon inspiration
timeFrame: change from baseline at 6 weeks
measure: specific airway resistance (siRaw) upon inspiration
timeFrame: change from baseline at 6 weeks
Secondary outcomes:
measure: siVaw upon expiration
timeFrame: change from baseline at 6 weeks
measure: siRaw upon expiration
timeFrame: change from baseline at 6 weeks
measure: ventilation mapping
timeFrame: change from baseline at 6 weeks
measure: perfusion mapping
timeFrame: change from baseline at 6 weeks
measure: airway wall thickness upon inspiration
timeFrame: change from baseline at 6 weeks
measure: imaged lobe and lung volumes at Total Lung Capacity (TLC) and Functional Residual Capacity (FRC)
timeFrame: change from baseline at 6 weeks
measure: air trapping
timeFrame: change from baseline at 6 weeks
measure: low attenuation score at TLC
timeFrame: change from baseline at 6 weeks
measure: Percentile 15th at TLC
timeFrame: change from baseline at 6 weeks
measure: regional lung deposition
timeFrame: change from baseline at 6 weeks
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: OLV Hospital Aalst
city: Erpent
country: Belgium
facility: Centre medical Erpent - Residence
city: Knokke
country: Belgium
facility: AZ Zeno Knokke-Heist
city: Reet
country: Belgium
facility: Heilige Familie AZ
city: Roeselare
country: Belgium
facility: AZ Delta
city: Balassagyarmat
country: Hungary
facility: Dr. Kenessey Albert Hospital
city: Budapest
country: Hungary
facility: National Koranyi Institute for TB and Pulmonology
city: Miskolc
country: Hungary
facility: CRU Hungary Ltd
Study officials:
References: