2024-04-25
minor
Study Status, Contacts/Locations v8
Study sitesdetails revised at 3 of 20 sites
2023-12-22
minor
Study Status, Contacts/Locations v7
Study sitesdetails revised at 2 of 20 sites
2023-09-25
minor
Study Status, Contacts/Locations v6
Primary completion date2024-03→2026-10
Completion date2024-04→2026-11
Study sites16→20
2023-03-17
minor
Study Status, Arms and Interventions, Eligibility, Contacts/Locations v5
Eligibility criteria-244 characters
[...] a controlled asthma worsening after decreasing medications,
Pre-BronchoDilatator (BD) FEV1 <80% of the predicted value at M-1.
Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200 milliliter
ACQ-7 score ≥ 1,5 at M-1 and M0.
≥ 3 exacerbations in the 12 months prior to screening visit M-1.
Eosinophil blood count ≥ 0,3 G/L at screeninginclusion visit or in the 12 months prior to the screeninginclusion visit.
If eosinophil blood count is ≥ 0,15 G/L and < 0,3 G/ [...] equired:
Fractional Exhaled Nitric Oxide (FeNO) > 25 ppm at screeninginclusion visit or in the 12 months prior to the scree [...] [...]
Study sitesdetails revised at 8 of 16 sites
2021-10-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v4
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2021-10→confirmed 2021-10-11
Study sitesdetails revised at 16 of 16 sites
Show 3 earlier versions
2021-09-27
minor
Study Status, Eligibility, Contacts/Locations v3
Start date2020-12→2021-10
Study sites15→16
Eligibility criteria-50 characters
[...] tients diagnosed with difficult-to-treat asthma and/or with uncontrolled asthma differential diagnosis thataccording haveto notthe yetjudgment beenof excludedthe investigator (e.g., vocal cord dysfunction, gastroesophageal reflux disease, gra [...] lergic broncho-pulmonary aspergillosis, Carrington disease, Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNEC)DIPNECH, asthma/ chronic obstructive pulmonary disease (COPD) overlap syndrome).
Non-adherent patients to inhaled treatme [...] biotherapy than Benralizumab that affects the immune system
SARS-COV2 infection
Pregnancy, lactation, or pat [...]
2020-12-10
minor
Study Status v2
Re-verified, no change to tracked fields
2020-09-28
minor
Study Status, Study Description, Outcome Measures, Eligibility v1
Eligibility criteria+162 characters
[...] ntrolled asthma worsening after decreasing medications,
Pre-BronchoDilatator (BD) FEV1 <80% of the predicted value at M-1.
Documented historical reversibility of FEV1 ≥12% and FEV1 gain ≥ 200mL.200 milliliter
ACQ-7 score ≥ 1,5 at M-1 and M0.
≥ 3 exacerbations in the 1 [...] d by at least 1 of the following criteria will be required:
Fractional Exhaled Nitric Oxide (FeNO) > 25 ppm at screening visit or in the 12 months prior to th [...] lergic broncho-pulmonary aspergillosis, Carrington disease, Diffuse idiopathic pulmonary neuroendocrine cell hyperplasia (DIPNEC), asthma/ chronic obstructive pulmonary disea [...] [...]
Secondary endpoints6 entries, revised
Association of gene expression patternsandpatterns and clinical characteristics
2020-09-21
minor
Original filing