Asthma MedDRA version: 22.1 Level: LLT Classification code 10003555 Term: Asthma bronchial System Organ Class: 100000004855
Conditions
Interventions
Trade Name: BF Spiromax
Product Name: Budesonide/formoterol (BF) Digihaler Digital System (DS)
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: Budesonide
CAS Number: 51333-22-3
Concentrati
Sponsors
Franciscus Gasthuis & Vlietland
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Confirmed asthma diagnosis (=12% and =200 ml reversibility in FEV1 or positive histamine/methacholine provocation test or FeNO >50) according to the asthma guidelines. - Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab) as determined at the regional asthma MDTM according to the asthma guidelines. - Age = 18 years. - Previous prescribed asthma biologics have to be ceased = 4 times the half-life of that specific biologic. - The patient has be relatively stable. The onset of an asthma exacerbation and/or a lower respiratory tract infection which requires a treatment with prednisolone and/or antibiotics has to be = 2 weeks ago. 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: - Primary COPD diagnosis - History of cancer: > Current basal cell carcinoma of the skin, localized squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to the start of the study. > Current other malignancies. Patients are eligible to participate in the study provided that curative therapy was completed at least 5 years prior to the start of the study. - Inability to fully understand and read the Dutch language. - Being unable to engage in a remote monitoring and coaching program through the use of a smartphone. - Being unable to engage in physical activity (e.g. physical disability). - Current pregnancy. - Current breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate if the EXACT@home program reduces the number of patients treated by biologics by means of systematic identification and treatment of treatable traits using e.g. questionnaires, eHealth and multiple digital devices before considering biologics.;Secondary Objective: To determine whether the use of EXACT@home results in a reduced percentage of patients treated with biologicals after 11-12 months. Next to this it will be investigated if EXACT@home has an influence on quality of life, asthma control, dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct healthcare consumption, self-management skills, patient satisfaction, adherence to ICS/LABA therapy and inhaler technique, physical activity, sleep and vital parameters. Next to this, breath pattern analysis will be performed with the electronic nose (eNose). Moreover, the safety of the Digital inhaler (BF-Digihaler-DS from Teva) and eNose (Spironose from Breathomix) and the course of the treatment in each patient will also be investigated. ;Primary end point(s): Reduction in number of patients treated by biologics in the treatment arm (EXACT@home) compared to the control arm (gold standard: immediate start of biologics after the indication is determined at the regional asthma MDTM). ;Timepoint(s) of evaluation of this end point: After 6 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients treated with biologicals after 11-12 months of follow up, quality of life, asthma control, dyspnea perception, lung function, exacerbation frequency, prednisolone use, direct healthcare consumption, self-management skills, patient satisfaction, adherence to ICS/LABA therapy, inhaler technique, physical activity, sleep, vital parameters, breath pattern analysis with the eNose, safety of the BF-Digihaler-DS (digital inhaler) and SpiroNose (eNose) and the course of the treatment in each patient.;Timepoint(s) of evaluation of this end point: After 6 and 11-12 months. | — |
Countries
Netherlands
Contacts
Public ContactHospital
Franciscus Gasthuis & Vlietland
Outcome results
None listed