Subjects aged 18 years or older, at the time of signing the informed consent.
Subjects with documented physician diagnosis of asthma as their primary respiratory disease.
ACT score <20 at screening visit.
Non-smokers (never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked).
Male or female subjects will be included. A female subject is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: (i) Not a woman of childbearing potential (WOCBP). (ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 5 days] after the last dose of study treatment.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and protocol.
Subject understands and is willing, able, and likely to comply with study procedures and restrictions.
Subject must be able to read in a language supported by the smart phone app in their region.
Subject must have been on maintenance therapy (Fixed dose combination ICS/LABA) for 3 months, cannot have changed dose in the month prior to screening and be able to change to an equivalent dose of RELVAR/BREO for the duration of the study. Other background asthma medication such as anti-leukotrienes and oral corticosteroids are permitted provided the dose has been stable for 1 month prior to screening.
Subject must be able to change to Salbutamol/Albuterol MDI rescue for the duration of the study and judged capable of withholding albuterol/salbutamol for at least 6 hours prior to study visits.
Subject must have their own Android or iPhone operating system (IOS) smart phone and a data package suitable for the installation and running of the app and sending and receiving data. Data used by the CIS is approximately 1 megabyte (MB) per month as a maximum; this is less data than a 1 minute video streamed from YouTube (2MB).
Subjects must be willing and able to download the app on their personal smart phone and keep it turned on for the duration of the study. This will also require Bluetooth to be turned on for duration of the study. Subjects will also have to turn on mobile data for the app for the duration of study; unless travelling and when extra data roaming costs could be incurred.
ACT score <20 at randomization visit (visit 2).

NCT03380429_inc_T1
Person
aged
NCT03380429_inc_T2
Value
18 years or older
NCT03380429_inc_T3
Temporal
at the time of signing the informed consent
NCT03380429_inc_T4
Reference_point
signing the informed consent
NCT03380429_inc_T5
Condition
asthma
NCT03380429_inc_T7
Qualifier
primary respiratory disease
NCT03380429_inc_T6
Measurement
ACT score
NCT03380429_inc_T8
Value
<20
NCT03380429_inc_T9
Temporal
at screening visit
NCT03380429_inc_T10
Observation
Non-smokers
NCT03380429_inc_T11
Observation
never smoked
NCT03380429_inc_T12
Observation
not smoking
NCT03380429_inc_T13
Temporal
for >6 months
NCT03380429_inc_T14
Value
<10
NCT03380429_inc_T15
Measurement
pack years
NCT03380429_inc_T17
Scope
never smoked or not smoking for >6 months with <10 pack years history (Pack years = [cigarettes per day smoked/20] multiplied by number of years smoked
NCT03380429_inc_T18
Person
Male
NCT03380429_inc_T19
Person
female
NCT03380429_inc_T24
Procedure
maintenance therapy
NCT03380429_inc_T25
Multiplier
Fixed dose
NCT03380429_inc_T26
Drug
combination ICS/LABA
NCT03380429_inc_T27
Temporal
for 3 months
NCT03380429_inc_T28
Negation
cannot
NCT03380429_inc_T29
Multiplier
changed dose
NCT03380429_inc_T30
Temporal
in the month prior to screening
NCT03380429_inc_T31
Reference_point
the month prior to screening
NCT03380429_inc_T33
Mood
able to
NCT03380429_inc_T34
Procedure
change
NCT03380429_inc_T35
Drug
Salbutamol
NCT03380429_inc_T36
Drug
Albuterol
NCT03380429_inc_T37
Procedure
MDI rescue
NCT03380429_inc_T38
Temporal
for the duration of the study
NCT03380429_inc_T39
Reference_point
the duration of the study
NCT03380429_inc_T40
Condition
capable of withholding
NCT03380429_inc_T41
Drug
albuterol
NCT03380429_inc_T42
Drug
salbutamol
NCT03380429_inc_T43
Multiplier
for at least 6 hours
NCT03380429_inc_T44
Temporal
prior to study visits
NCT03380429_inc_T45
Scope
albuterol/salbutamol
NCT03380429_inc_T48
Measurement
ACT score
NCT03380429_inc_T49
Value
<20
NCT03380429_inc_T50
Temporal
at randomization visit