This study is designed to assess the proportion of asthma and COPD subjects making critical and non-critical errors in using NEXThaler compared with Turbuhaler after 4 weeks of clinical use. This will give insight in the importance of triple…
ID
Source
Brief title
Condition
- Bronchial disorders (excl neoplasms)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The effectiveness of inhaled medications in asthma and COPD is strongly
influenced by the compliance to these medications. The choice and design of the
inhalation device plays a significant role in the effectiveness of inhaler
therapy. Poor efficacy can be caused by a decreased medication delivery
associated with an incorrect inhaler technique for the device being used. When
patients are prescribed an inhaler, the choice should in part be based on how
easy an inhaler is to use, and training to minimise errors in the use of the
device.
A correct inhalation is as important as the development of an efficaious and
safe drug. The NEXThaler is able to provide users feedback through three
different mechanisms, users are able to verify whether their inhalation is
performed at all and performed correctly. It is assumable that this triple
feedback mechanisms provide added value above other inhalers lacking these
mechanisms, resulting in a higher percentage of patients performing the
inhalation correctly and with less instruction time needed after one month of
actual use. However plausible as it sounds, this has not yet been investigated
in a clinical setting.
Study objective
This study is designed to assess the proportion of asthma and COPD subjects
making critical and non-critical errors in using NEXThaler compared with
Turbuhaler after 4 weeks of clinical use. This will give insight in the
importance of triple feedback mechanisms in an inhaler device. This study will
also compare the ease of use and preference of NEXThaler compared to
Turbuhaler.
Study design
An interventional, open-label, randomized, cross-over, 2-arm, multi-center
study.
Intervention
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 instruction by the research assistant.
Here the number of required instructions, time and critical errors are noted.
The patient will use both inhalers at home for a period of 4 weeks. The
ICS/LABA combination in the NEXThaler with beclomethasone/formterol 100/6 two
inhalations twice daily is equivalent to the Turbuhaler with
budesonide/formoterol 200/6 two inhalations twice a day.
At the end of the study the patient will be asked to ease of use and
preference of NEXThaler compared to Turbuhaler
Study burden and risks
Patients come extra to the hospital with a maximum of 4 times, during these
visits the patient will read the manual, receive instructions and demonstrate
the use of both inhalers.
The overall potential risk in this study is minimal due to the nature of the
study; both inhalers are available on a commercial market and have a broad base
experience.
Koningsplein 1
Enschede 7512 KZ
NL
Koningsplein 1
Enschede 7512 KZ
NL
Listed location countries
Age
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL69067.100.19 |