asthma bronchospasms
Conditions
Interventions
For this study, a Respiro¬TM add-on device is attached to the current inhaler
therapy to measure parameters such as date and time of inhalation, orientation
of the inhaler, peak flow, duration of th
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Patients from 18 years or older. - Patients who suffer from difficult to treat asthma. - Patients are under treatment in MST
Exclusion criteria
Exclusion criteria: - Patients who are unable to speak or understand the Dutch language. - Current smokers - Patients who are not compatible with the medication delivered through the Nexthaler, Ellipta or Spiromax. Switch between dosis aerosol and dry powder inhaler device is allowed if the medication remains the same. Patients should use this device at least a month before entering the study. - Patients with a chronic disease other than asthma that can influence the lung function. - Patients who use a biological drug for their asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is clinical improvement in asthma control in patients with difficult to treat asthma between phase 1 and phase 2 and the course of asthma control in phase 3. Clinical improvement in asthma control is assessed by a lung function test, the ACQ score and the AQLQ score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include the therapy adherence and inhalation technique. Therapy adherence is the rate of which the patient takes his inhalation medication at the appropriate frequency time. If the therapy adherence rate equals or exceeds the 75% (subjects take their medication twice daily in 75% or more percent of the days), the patient is considered therapy adherent. Next to the dichotomous way of measuring adherence, patients will also be classed in underuser (125%) based on adherence rates.24 Inhalation technique is defined as the amount of times a patient inhales the medication correctly with regard to technique of the inhalation and orientation of the inhaler. To be able to determine the therapy adherence and inhalation technique, date and time of inhalation, the position of the device during inhalation, peak flow, the duration of the inhalation, the total volume and opening and closing of the device will be measured. All (critical) errors made will be recorded. Furthermore, after phase 1, patient factors related to poor adherence are determined. These are included in the secondary study parameters and their role in the therapy adherence will be assessed. FeNO will be measured using a NIOX MINO (Aerocrine AB, Stockholm, Sweden) according to American Thoracic Society/European Respiratory Society recommendations at a 50 ml/s flow rate.25 FeNo will be measured at inclusion and at the end of phase 2. Blood eosinophil count will be measured at inclusion (or in case this was measured less than 3 months before inclusion, the latter measurement will be used as baseline eosinophil count) and at the end of phase 2. Blood eosinophil count will be expressed as a continous measure as well as above or below the cut-off of the eosinophilic (blood eosinophil count >=0.3×109 L*1; suitable for anti-IL-5 therapy) or allergic phenotype (serum IgE level >=30 kU·mL*1).26 | — |
Countries
Netherlands
Outcome results
None listed