Effect of Reslizumab on small airways in asthma. RESSAPEA

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-003958-16-NL

Enrollment

Registered

2018-06-06

Start date

2018-08-10

Completion date

Unknown

Last updated

2018-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

1. Patients with severe eosinophilic asthma MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855

Interventions

Trade Name: Cinqaero Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Blood eosinophil counts =0.4 x 10E9/L despite adequate treatment with high doses of inhaled corticosteroids (>800mcg/day fluticaone equivalent) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 11

Exclusion criteria

Exclusion criteria: • Eosinophilic Diseases: Subjects with other conditions that could lead to elevated eosinophils such as Hyper eosinophilic Syndromes, including Churg-Strauss Syndrome, or Eosinophilic Esophagitis.

Design outcomes

Primary

Measure	Time frame
Main Objective: 1. To investigate the effect of 3 months treatment with Reslizumab on air trapping, by using different techniques;Secondary Objective: To investigate the degree of (dynamic) hyperinflation in patients with severe eosinophilic asthma, and relate it to the percentage of eosinophils in peripheral blood and sputum Study.;Primary end point(s): in this study is the change from baseline in regional image based hyperinflation (iVlobes ) and in (specific) iVaw after 3 months Reslizumab treatment compared to changes in the placebo group.;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks	—

Measure

Time frame

Main Objective: 1. To investigate the effect of 3 months treatment with Reslizumab on air trapping, by using different techniques;Secondary Objective: To investigate the degree of (dynamic) hyperinflation in patients with severe eosinophilic asthma, and relate it to the percentage of eosinophils in peripheral blood and sputum Study.;Primary end point(s): in this study is the change from baseline in regional image based hyperinflation (iVlobes ) and in (specific) iVaw after 3 months Reslizumab treatment compared to changes in the placebo group.;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): (specific) iRaw, exploratory parameters from FRI, iVlung, air trapping specific imaged-based airway volume (s)iVaw) at TLC, internal lobar airflow distribution, low attenuation or emphysema score, blood vessel density, airway wall thickness and aerosol deposition concentrations, Also correlations between changes in HRCT parameters and SGRQ, AQLQ, ACQ, FEV1/FVC, FVC, FRC, RV/TLC, FeNO and cell differential counts in sputum and blood. ;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks	—

Measure

Time frame

Secondary end point(s): (specific) iRaw, exploratory parameters from FRI, iVlung, air trapping specific imaged-based airway volume (s)iVaw) at TLC, internal lobar airflow distribution, low attenuation or emphysema score, blood vessel density, airway wall thickness and aerosol deposition concentrations, Also correlations between changes in HRCT parameters and SGRQ, AQLQ, ACQ, FEV1/FVC, FVC, FRC, RV/TLC, FeNO and cell differential counts in sputum and blood. ;Timepoint(s) of evaluation of this end point: Baseline and 12 weeks

—

Countries

Netherlands

Contacts

Public ContactAcademic Medical Center

Academic Medical Center

p.f.mau-asam@amc.uva.nl31205663554

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026