Severe asthma MedDRA version: 21.1 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
Conditions
Interventions
Trade Name: Nucala
Pharmaceutical Form:
INN or Proposed INN: Mepolizumab
CAS Number: 196078-29-2
Other descriptive name: MEPOLIZUMAB
Concentration unit: mg milligram(s)
Concentration type: equal
Conc
Sponsors
Bispebjerg Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Informed written consent - Age > 18 years - Correct asthma diagnosis as judged by (sub)-investigator - Treatment with anti-IL5/IL5r for 12 months or longer - Treatment with the same biologic drug in the last 12 months - No exacerbations requiring OCS in the last 12 months - Blood eosinophils =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: - Active smoking - Pregnant or breastfeeding females - Lack of effective contraception in women of childbearing potential who are sexually active with a non-sterilized male partner. Women of childbearing potential are defined as those who are not surgically sterile (e.g. bilateral tubal ligation, bilateral oophorectomy, complete hysterectomy) or postmenopausal (defined as 12 months with no menses without an alternative medical cause). Effective contraception is defined as intrauterine device (hormonal or non-hormonal), sexual abstinence, bilateral tubal occlusion, combined (estrogen and progesterone) hormonal contraception (oral, intravaginal and transdermal) and progesterone-only hormonal contraception (oral, injectable and implantable). - Previous medical history or evidence of an uncontrolled intercurrent illness such as but not limited to (e.g. Autoimmune disease, immunodeficiency, immunosuppression, malignant neoplastic conditions with current relevance) that in the opinion of the investigator may compromise the safety of the subject in the study or interfere with evaluation of the algorithm or reduce the subject’s ability to participate in the study. Subjects with well-controlled comorbid disease (eg, hypertension, hyperlipidaemia, gastroesophageal reflux disease) on a stable treatment regimen for 15 days prior to inclusion are eligible. - Any concomitant respiratory disease that in the opinion of the investigator and/or medical monitor will interfere with the evaluation of the algorithm or interpretation of subject safety or study results (eg. chronic obstructive pulmonary disease, cystic fibrosis, pulmonary fibrosis, bronchiectasis, allergic bronchopulmonary aspergillosis, eosinophilic granulomatosis polyangitiis, alpha-1-antitrypsin deficiency, Wegeners granulomatosis, Sarcoidosis).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The purpose of the OPTIMAL study is to is to examine the OPTIMAL algorithm as a clinical tool for safe dose titration of biologics in patients with severe asthma. We will investigate if treatment with biologics can be stepped down or even terminated in some patients without loss of disease control. We will investigate possible predictors of successful dose tapering in order to identify patients who are can have their dosage tapered and those who cannot. The OPTIMAL study will also describe potential adverse effects of stepping down or discontinuing treatment. The OPTIMAL study will focus on biologics with an anti-IL5/IL5r effect. We will also describe immunological changes during dosetitration. ;Secondary Objective: Not applicable;Primary end point(s): To compare the proportion of patients with sustained asthma control in the group of patients having their dose of biologics titrated with the OPTIMAL algorithm with the proportion of patients with sustained disease control in the group of patients who continue normal dosage. ;Timepoint(s) of evaluation of this end point: At 52 weeks (End of trial) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the proportion of patients, who have achieved disease control on biological treatment that can be stepped down in treatment without loss of disease control To compare the time to first asthma exacerbation in patients having their dose of biologics titrated with the OPTIMAL algorithm with the group of patients who continue normal dosage. To identify predictors of successful step down of treatment To describe potential unwanted consequences of step down or discontinuing treatment ;Timepoint(s) of evaluation of this end point: At 52 weeks (End of trial) | — |
Countries
Denmark
Contacts
Public ContactLungemedicinsk Forskningsenhed
Bispebjerg Hospital
Outcome results
None listed