The primary objective of this study is to improve asthma control in adults with difficult to treat asthma, by increasing therapy adherence and inhalation technique with qualitative feedback.
ID
Source
Brief title
Condition
- Congenital respiratory tract disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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 (<50%), suboptimal users (50-<75%), optimal
users(75-125) and overusers (>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
Background summary
Severe uncontrolled asthma is associated with substantial morbidity and health
care costs. Before prescribing expensive add-on therapies (e.g. biologicals)
clinicians should address adherence to therapy and inhaler technique. Previous
studies have shown that around 50% of patient with difficult to treat asthma is
not adherent to medication. In this study, the effect of providing qualitative
feedback on therapy adherence and inhalation technique is assessed.
Study objective
The primary objective of this study is to improve asthma control in adults with
difficult to treat asthma, by increasing therapy adherence and inhalation
technique with qualitative feedback.
Study design
The first phase consists of a 1 month observational study period, where the
therapy adherence and inhalation technique of the patients is assessed.
Parameters related to poor adherence are determined in this phase. The second
phase of 3 months consists of a randomised controlled trial where one group
receives qualitative feedback on therapy adherence and inhalation technique and
the other group does not receive feedback. Finally, in phase 3, the lasting
effect of qualitative feedback will be assessed. This phase is an observational
follow-up traject in which the feedback will be ceased for all patients and
revision of current therapy may occur, depending on findings in phase 2
Intervention
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 the inhalation,volume of flow and
opening and closing the inhaler.
Study burden and risks
The burden of this study pertains to one additional visit for instructions and
three additional visits to the hospital to assess the lung function by
spirometry. Furthermore, a ACQ and AQLQ questionnaire needs to be filled in at
the start of phase 1 and at the end of each phase. The potential benefit of
this study is that by improving therapy adherence and inhalation technique,
asthma control may be improved.
Koningsplein 1
Enschede 7500 KA
NL
Koningsplein 1
Enschede 7500 KA
NL
Listed location countries
Age
Inclusion criteria
- Patients from 18 years or older.
- Patients who suffer from difficult to treat asthma.
- Patients are under treatment in MST
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
Recruitment
Medical products/devices used
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 | NL71910.100.19 |