BIOlogical treatment GRAdual Interval Longing in severe Asthma (BIO-GRAIL)

Condition studied

Severe Asthma

Investigational medicinal product(s)

Every trial of Benralizumab, Mepolizumab, Tezepelumab and Dupilumab across our registers →

Eligibility

Primary endpoint

Maintained asthma control after ~1 year of study participation with at least one step of interval prolongation. Asthma control is defined as not more than one additional exacerbation compared to baseline frequency during ~1 year and a ACQ < 2.0 at the last study visit. An exacerbation is defined as an acute worsening of symptoms lasting more than 48 hours, as assessed by the treating physician.

Endpoint detail

Exacerbation frequency per year., Blood eosinophile count in *10^9 cells per liter, FeNO in parts per billion (ppb), Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC, Asthma Control Questionnaire (ACQ), Severe Asthma Questionnaire (SAQ), Sino-Nasal Outcome Test (SNOT-22), Strict asthma control after algorithm guided interval prolongation for ~1 year. Strict asthma control is defined as ΔACQ < 0.5 and control of biomarkers., Detection of respiratory viruses during asthma exacerbations by PCR on nasopharyngeal swab, Blood eosinophile count in *10^9 cells per liter during asthma exacerbations, FeNO in parts per billion (ppb) during asthma exacerbations, ACQ during asthma exacerbations, SAQ during asthma exacerbations, Dosage of Inhaled Corticosteroids (ICS), Inhaler technique, 5 – item Medication Adherence Report Scale (MARS-5)