Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04262271 |
| Other study ID # |
PHT/2019/13 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 7, 2019 |
| Est. completion date |
June 30, 2022 |
Study information
| Verified date |
April 2023 |
| Source |
Portsmouth Hospitals NHS Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This study will observe the inhaler technique of people using 13 different inhaler types;
record any technique errors being made against checklists developed for each inhaler device
based on their manufacturer's guidelines, and reeducate any observed inhaler technique errors
as required.
Description:
Anyone aged 16 or over who has a lung condition for which they use an inhaler will be invited
to join the study. The investigators will recruit a minimum of 650 study participants, with
at least 50 participants using each of the 13 inhaler device types selected. These inhaler
device types include: Accuhaler, Autohaler, Breezhaler, Easi-breathe, Easyhaler, Ellipta,
Genuair, Handihaler, Nexthaler, pMDI, pMDI plus spacer, Respimat and Turbohaler. Participants
will be recruited from respiratory outpatient clinics, hospital wards and from staff at Queen
Alexandra Hospital (QAH); from integrated outreach lung clinics, GP database searches,
clinics run in primary care settings, respiratory support groups in the Hampshire region, and
from students at the University of Portsmouth (UoP).
Participants in this study will have their inhaler technique observed and corrected by a
specialist clinician, such as a nurse, pharmacist, physiotherapist or doctor using a
single-use placebo device. A placebo device is exactly the same as the inhaler that the
participant uses, but there is no active medication in the device. If any errors are made
using the placebo inhaler, these will be recorded using device-specific checklists based on
manufacturers' guidelines.
Correcting inhaler technique is vitally important in the management of respiratory conditions
. Observing patients using their inhaler, identifying any errors in their technique, teaching
the correct inhaler technique and then observing the patient repeating the procedure
correctly should occur at the time of device prescription; however this often does not happen
and patients are left unsure how to use their inhaler and errors are commonplace. After
inhaler technique has been corrected in this study, a written information sheet with guidance
on how to use the inhaler will be provided to each participant to help reinforce the correct
technique.
Alongside recording any errors that participants using the inhalers have made, the
investigators will also record additional information such as the type of inhaler they are
observed using and how long they have been using that inhaler; their age, gender and how many
other inhalers they are using in total; which lung condition they have and how badly it
affects them and if they have any other medical conditions. The investigators will also
record information using a questionnaire called the SPURTM profiling tool, which assesses
patients' beliefs and understanding around their medication; this will be done using an
iPad/tablet and all data that is inputted will be anonymous and kept securely, as with all
other information.
The information collected on this study will help HCP better understand which inhaler
technique errors are made most frequently associated with each different inhaler device. The
investigators will also use the information gathered in this study, along with additional
information gathered from inhaler experts, to develop a method of scoring inhaler technique
errors, which will be tested in a future study. Such a scoring system does not currently
exist in the UK and will be a valuable tool in clinical practice to accurately measure how
good people are at using their inhalers.
