Asthma COPD
Conditions
Interventions
Patients are asked to use 2 different inhalers in both study arms They will be
asked to read the instructions for use of the inhaler and to demonstrate the
use of the inhaler (with placebo) after in
Sponsors
Medisch Spectrum Twente
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent: • Subject must give their signed and dated written informed consent to participate • Subject understands and is willing, able, and likely to comply with study procedures and restrictions • Subject must be able to read, comprehend, and record information in Dutch 2. Age: >=18 years of age 3. Gender: male or female subjects (sex-ratio may not exceed 25% : 75%, either way) 4. Clinical diagnosis of Asthma or clinical diagnsosis of COPD (Gold I-IV). Comorbidities (rheumatoid arthritis or other locomotor problems, visual impairment, and depression or anxiety) will be documented as relevant to inhaler use 5. Asthma or COPD status and treatment: stable, well controlled on current medication treatment with use of ICS and LABA or an indication (following GOLD en GINA criteria) or the use of ICS/LABA combination 6. Must be naive for using the NEXThaler and TurbuHaler for the last 2 years
Exclusion criteria
Exclusion criteria: 1. Treatment with monoclonal antibodies (omalizumab, mepolizumab, benralizumab and reslizumab) 2. Body malformations or diseases affecting coordination and/or motor systems necessary for adequately using inhalation devices 3. Intolerance for any of the medication substances 4. Subjects who are currently participating in another randomised pharmacological inter-ventional trial 5. Inability to read or answer patient reported questionnaires and manuals 6. Lactose intolerantie 7. Pregnant or giving breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the percentage of asthma and COPD patients performing all critical inhalation items correctly with the NEXThaler vs the Turbuhaler after 4 weeks of twice daily use of both inhalers. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the number of instructions and time needed to achieve correct use of each device (all inhalation correct) at the first visit. To assess the patients* satisfaction, willingness to continue and overall preference for NEXThaler vs. Turbuhaler inhaler devices after 4 weeks of daily use of both inhalers. Build a prediction model (patient characteristics and literacy assessment) for sustainability of the inhalation technique. | — |
Countries
Netherlands
Outcome results
None listed