A randomized, multi-center, open-label, cross-over study comparing critical errors, overall errors, training/teaching time, and preference attributes of the ELLIPTA dry powder inhaler versus the BREEZHALER dry powder inhalers, in adult participants with mild to moderate asthma.

The importance of correct use of inhalers is emphasised by GINA for asthma
patients and by GOLD for patients with chronic obstructive pulmonary disease
(COPD) by ensuring selection of the appropriate inhaler, demonstration of the
inhaler and assessment of inhaler use is reviewed prior to escalating therapy.
Errors made by the patient can affect the amount of medication received and
disease control so it is essential to ensure good inhaler technique.
Comparison of inhaler techniques between asthma and COPD patients suggests some
inconsistencies with some observational studies demonstrating similar error
rates and other studies demonstrating higher rates in COPD patients but when
adjusting for age, inhaler and level of instruction, this difference
disappeared. Study designs often observational, in usual practice with
patients being familiar with their inhalers, in different geographical and
socio-economic areas may account for the inconsistent effects. Older, lower
socio-economic and educational levels and female gender were risk factors for
greater errors in inhaler handling.
The ELLIPTA DPI was developed to deliver various inhaled maintenance
medications, including mono, dual and triple therapies, for the treatment of
asthma and COPD. ELLIPTA has been designed to be simple to use. Participants
with asthma or COPD make fewer critical errors (defined as an error that is
most likely to result in no or significantly reduced medication being inhaled)
and overall errors (any error in inhaler technique) with the ELLIPTA DPI than
with other DPIs. Furthermore, participant preference for the ELLIPTA DPI has
been demonstrated previously versus other DPIs for many attributes, including
ease of use and time to train. The BREEZHALER DPI is also approved for use
with a variety of inhaled mono- or combination-medications although BREEZHALER
has not been widely used by asthma patients.
The study involves the use of placebo DPI inhalers (placebo ELLIPTA and
BREEZHALER) that do not contain active treatments. Participants will continue
to take their own prescribed asthma medication and other concomitant medication
during the study. Participants should also follow-up with their regular
physician for their asthma healthcare during the study.
The placebo inhaler for ELLIPTA and the placebo capsules for BREEZHALER contain
the excipients lactose.

Primary objective:
To compare the proportion of participants who make at least one critical error
after reading the section on inhaler use in the patient information leaflets
(PILs) for ELLIPTA and BREEZHALER inhalers

Secondary Objectives:
To compare the proportion of participants who still make at least one critical
error after receiving further instruction from the Healthcare Professional
(HCP) for ELLIPTA and BREEZHALER inhalers

To compare the proportion of overall errors made by the participants after
reading the PIL, and if necessary, with additional instruction from the HCP for
ELLIPTA and BREEZHALER inhalers

To summarise the number of errors (critical and overall) made on each inhaler,
with or without further HCP instruction.

To compare the proportion of participants that require further instruction from
the HCP to demonstrate correct inhaler use for ELLIPTA and BREEZHALER inhalers

To compare the Training/Teaching Time required to demonstrate correct inhaler
use for ELLIPTA and BREEZHALER inhalers.

To compare ease-of-use for ELLIPTA and BREEZHALER inhalers

To summarise ease-of-use for ELLIPTA and BREEZHALER inhalers

To compare the willingness to continue with the ELLIPTA and/or BREEZHALER
inhaler

To compare preference attributes for ELLIPTA and BREEZHALER inhalers

The study will be a randomized, multi-center, open label, placebo study with a
2x2 complete block crossover design. The study will have one visit (although
there could be two visits with up to 30 days between the informed consent visit
(V0) and the study intervention visit (V1).
Eligible participants with mild to moderate asthma will be randomized to test
either the ELLIPTA DPI (containing placebo) followed by BREEZHALER DPI (with
placebo capsules), or vice versa in each of the two blocks for the crossover
study. Only participants who are naïve to both ELLIPTA and BREEZHALER inhaler
will be included.

Participants will demonstrate inhaler use for the first inhaler after reading
the relevant sections of the PIL (Attempt 1). If the participant makes any
errors, the investigator demonstrates the correct use of the inhaler by
conducting a full demonstration as described in the relevant section of the
PIL, and the participant will try inhaler use again (Attempt 2). If after the
first demonstration by the investigator the participant continues to make
errors, the investigator will demonstrate correct inhaler use to the
participant up to two additional times (Attempts 3 & 4).

Following each attempted use of the inhaler by the participant, the trained
investigator will assess for and document any critical errors (i.e. defined as
an error that is most likely to result in no or significantly reduced
medication being inhaled) and non-critical errors made by the participant. This
process of error assessment will be used to assess for critical and
non-critical errors made by the participant for both inhalers being tested.
At the end of the assessment of the first inhaler, participants will be asked
to complete the ease-of-use questionnaire for this device followed by
participant completion of the visual analogue scale (VAS) on their willingness
to continue with this inhaler.

Participants will be permitted up to a 30-minute break (if required) between
completing the assessment of the first inhaler and commencing error assessments
for the second inhaler. The second inhaler critical errors assessment follows
the same sequence of testing as the first * (Attempts 1 is with no HCP
instruction and Attempts 2-4 are with HCP instruction as required).
Once the error assessment of the second inhaler has been completed the
participant will complete the ease-of-use questionnaire for this device
followed by participant completion of the visual analogue scale (VAS) on their
willingness to continue with this inhaler.

If required, another period of up to 30 min for a break would be allowed
followed by the participant completing one of the two versions of the
preference questionnaire, as per randomization sequence.
Two versions of the inhaler preference questionnaire are provided to minimise
any potential bias introduced from the order in which the inhalers are taken in
relation to the order the inhalers are assessed by the participant in each
questionnaire. The version of each questionnaire to be completed by each
participant is determined by the sequence arm they are randomly assigned to at
Visit 1.

inhalation of a placebo from a dry powder inhaler

As with other inhalation therapy, paradoxical bronchospasm may occur with an
immediate increase in wheezing after dosing. From post-marketing data from
FF/VI, paradoxical bronchospasm has been reported at a frequency of <1/10,000
including isolated reports.
The placebo inhaler for ELLIPTA and the placebo capsules for BREEZHALER contain
the excipient lactose. There are known allergies to this ingredient.
Participants with a known hypersensitivity to this or severe milk protein
allergy are excluded from the study.