The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by … (NCT04400318) | Clinical Trial Compass
CompletedPhase 4
The Effect of Dupilumab on Lung Inflammation and Related Changes in Airway Volumes Detectable by Functional Respiratory Imaging in Patients With Moderate-severe Asthma
United States109 participantsStarted 2020-06-20
Plain-language summary
Primary Objective:
• To assess the effect of dupilumab on lung inflammation and related changes in airway volumes detectable by functional respiratory imaging
Secondary Objective:
* To evaluate the effect of dupilumab at Week 24 on bronchodynamics, hyperinflation, airway resistance, airway wall thickness, ventilation defects and mucus plugging derived from high-resolution computed tomography (HRCT) scans, patient-reported outcomes, FeNO and spirometry.
* To evaluate safety of dupilumab
Who can participate
Age range18 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 to 70 years of age inclusive with the diagnosis of asthma based on Global Strategy for Asthma Management and Prevention (GINA) 2019 at the time of signing the informed consent
* History of ≥1 exacerbation(s) in the previous year
* Uncontrolled moderate to severe asthma (ACQ-5 ≥1.5) at visit (V)1 and V2, prior to randomization
* Pre-bronchodilator FEV1 ≤80% of predicted normal at V1 and V2, prior to randomization
* Exhibit bronchodilator reversibility (≥12% and 200 mL improvement in FEV1 post SABA administration) during screening, prior to randomization
* Blood eosinophil ≥300 cells /µL and FeNO ≥25 ppb during screening, prior to randomization
NOTES:
* Historical values of blood eosinophil count meeting the eligibility criterion measured within 6 months prior to SV1 in the absence of OCS treatment are allowed.
* FeNO value to be checked for eligibility at V2 as well. -Existing treatment with medium to high dose ICS in combination with a second controller (e.g. LABA, LTRA) ± a third controller. The dose regimen should be stable ≥1 month prior V1 and during screening.
Exclusion Criteria:
* Current smoker (cigarette or e-cigarette) or cessation of smoking within 1 year prior randomization
* Previous smoker with a smoking history \>10 pack-years
* Known hypersensitivity to dupilumab or any of its excipients
* A subject who experiences an asthma exacerbation (defined as a deterioration of asthma that results in emergency treatment, hospitalization due …
What they're measuring
1
Percentage of Participants Who Achieved Fractional Exhaled Nitric Oxide (FeNO) Less Than (<) 25 Parts Per Billion (Ppb) at Week 24
Timeframe: Week 24
2
Percent Change From Baseline to Week 24 in Untrimmed Distal Specific Airway Volumes ([s]iVaw) at Total Lung Capacity (TLC)