Functional Respiratory Imaging Study (DARWiIN) (NCT04876677) | Clinical Trial Compass
CompletedPhase 3
Functional Respiratory Imaging Study (DARWiIN)
Belgium25 participantsStarted 2021-05-18
Plain-language summary
The objective of this clinical study was to evaluate the tolerability, safety, and efficacy of stepping up from fluticasone propionate (FP)/salmeterol (SLM) dry-powder inhaler (DPI) (SERETIDEâ„¢ DISKUSâ„¢) to extrafine beclometasone dipropionate (BDP)/formoterol fumarate (FF)/glycopyrronium bromide (GB) DPI (CHF5993) and to assess its effect on airway geometry and lung ventilation in subjects with advanced Chronic Obstructive Pulmonary Disease (COPD).
Primary Objectives:
* Untrimmed siVaw for distal region at TLC - actual value for V2 pre-dose and V3 pre-dose
* Trimmed siRaw for distal region at TLC - actual value for V2 pre-dose and V3 pre-dose
Secondary Objectives:
* Untrimmed siVaw for distal region at TLC and FRC - actual value for V2 pre-dose, V2 post-dose, V3 pre-dose and V3 post-dose
* Trimmed siRaw for distal region at TLC and FRC - actual value for V2 pre-dose, V2 post-dose, V3 pre-dose and V3 post-dose
* Safety assessment through the evaluation of treatment-emergent adverse events (TEAEs).
Who can participate
Age range40 Years
SexALL
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Inclusion criteria
✓. Patient's signed ICF obtained prior to any study-related procedure;
✓. Male or female ≥40 years of age;
✓. Current smokers or ex-smokers of at least 10 pack-years, calculated as (number of cigarettes/day \* number of years)/20 (e-cigarettes smoking could not be used to calculate pack-year history);
✓. Established diagnosis of COPD according to the 2020 GOLD Report, prior to the V1;
✓. Post-BD FEV1/forced vital capacity (FVC) \<0.7 and FEV1 ≤60% of predicted at V1 (Note: if the criterion was not met at screening, the measure could be repeated once before run-in Day 1);
✓. On a stable dose of any non-extrafine ICS/LABA DPI twice daily regimen for at least 8 weeks before screening;
✓. Presence of lung hyperinflation based on the increase of TLC exceeding either the ULN or 120% of predicted, and/or a plethysmographic FRC exceeding either ULN or 120% of predicted;
✓. Symptomatic patients with COPD Assessment Test (CAT) score ≥10 at V1 and V2;
Exclusion criteria
What they're measuring
1
Untrimmed Airway Volume (siVaw) for Distal Region at Total Lung Capacity (TLC) - Actual Value for V2 Pre-dose and V3 Pre-dose
✕. Exacerbations defined as a sustained and acute deterioration of patient's symptoms and signs (dyspnoea, cough and/or sputum production/purulence) that were either moderate, i.e., required treatment with systemic (oral/intravenous \[IV\]/intramuscular \[IM\]) corticosteroids and/or antibiotics, or severe, i.e., required hospitalisation, if their associated treatment/hospitalisation occurred within the 30 days before V1 (or 4 weeks in case the event was treated with just systemic corticosteroids) or if the event was recorded during the run-in period;
✕. A current asthma diagnosis;
✕. Respiratory disorders other than COPD: patients with known respiratory disorders other than COPD that in the Investigator's opinion could affect efficacy and safety evaluation or place the patient at risk. This could include but was not limited to known α1-anti-trypsine deficiency, active tuberculosis, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and interstitial lung disease;
✕. Cardiovascular diseases: patients who had known clinically significant cardiovascular conditions such as but not limited to: unstable or acute ischaemic heart disease within one year prior to study entry, New York Heart Association (NYHA) class IV heart failure, history of atrial fibrillation, history of sustained, and non-sustained cardiac arrhythmias diagnosed within 6 months prior to study entry and not controlled with therapy according to the Investigator's opinion;
✕. Evidence or history of other concurrent disease such as but not limited to hyperthyroidism, diabetes mellitus, or other endocrine disease; haematological disease; autoimmune disorders (e.g,. rheumatoid arthritis); significant renal impairment; significant neurological disease or other disease or condition that might, in the judgement of the Investigator, place the patient at undue risk or potentially compromise the results or interpretation of the study;
✕. Medical history or current diagnosis of narrow-angle glaucoma, clinically relevant prostatic hypertrophy, or bladder neck obstruction that in the opinion of the Investigator could have prevented use of anticholinergic agents;
✕. History of lung transplant or lung reduction surgery;