Status:
COMPLETED
Functional Respiratory Imaging Study
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE3
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
- Subject's signed Informed Consent Form;
- Male or female ≥ 40 years of age;
- Current smokers or ex-smokers of at least 10 pack-years,
- Established diagnosis of COPD
- Post-BD Forced Expiratory Volume in one second/Forced Vital Capacity (FEV1/FVC) \< 0.7 and FEV1 ≤ 60% of predicted at V1
- On a stable dose any non-extra fine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
- Presence of lung hyperinflation
- Symptomatic subjects with COPD assessment test (CAT) score ≥ 10;
- Documented history of ≥ 1 moderate or severe COPD exacerbation in the previous 12 months
Exclusion
- Pregnant or lactating woman;
- Exacerbations defined as a sustained and acute deterioration of subject's symptoms and signs 30 days before screening;
- A current asthma diagnosis;
- Respiratory disorders other than COPD:
- Cardiovascular diseases;
- Evidence or history of other concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus or other endocrine disease;
- Medical history or current diagnosis of narrow-angle glaucoma;
- History of lung transplant or lung reduction surgery;
- 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;
- Laboratory abnormalities;
- Alcohol/drug abuse;
- Contra-indications to Investigational medical products (IMPs), based on investigator judgement;
- 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.
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2022
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04876677
Start Date
May 25 2021
End Date
January 3 2022
Last Update
January 25 2022
Active Locations (8)
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1
OLV Hospital Aalst
Aalst, Belgium
2
Centre medical Erpent - Residence
Erpent, Belgium
3
AZ Zeno Knokke-Heist
Knokke, Belgium
4
Heilige Familie AZ
Reet, Belgium