Obstructive airway disease, symptomatic airway narrowing
Conditions
Interventions
Patients with severe asthma who are eligible for treatment with biologics
(determined at the regional asthma Multi-Disciplinary Team Meeting (MDTM)) will
be included. Patients will be randomized in
2. A smart inhalation device with it's own application to monitor adherence to
inhalation therapy and inhaler technique): Budesonide/Formoterol electronic
multidose dry powder inhaler (BF-Digihaler)
3. An activity tracker with initially it's own application to measure physical
activity, vital parameters and sleep): Cardiowatch 287-2 from Corsano.
4. A Fraction of Expired Nitric Oxide (FeNO) meas
5. During the last week of the 6 weeks patients also receive a second activity
tracker according to standard care: DynaPort MoveMonitor from McRoberts.
The information of the Spirobank Oxi, the Viv
Sponsors
Franciscus
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Confirmed asthma diagnosis according to the asthma guidelines. - Diagnosed with severe, refractory asthma with eligibility for treatment with specific asthma biologics (omalizumab, mepolizumab, benralizumab, reslizumab, dupilumab, tezepelumab) as determined at the regional asthma Multi-Disciplinary Team Meeting (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.
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. - The patient must be stable. The onset of an asthma exacerbation and/or a respiratory infection has to be >= 4 weeks ago. - 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 |
|---|---|
| Difference between the intervention and control group in the percentage of patients treated with biologicals after 6 months of follow up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Contacts
Public ContactL Bult
Franciscus
Outcome results
None listed