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Rationale and design of a randomized trial of home electronic symptom and lung function monitoring to detect cystic fibrosis pulmonary exacerbations: the early intervention in cystic fibrosis exacerbation (eICE) trial.
[allergic bronchopulmonary aspergillosis]
Acute
pulmonary
exacerbations
are
central
events
in
the
lives
of
individuals
with
cystic
fibrosis
(
CF
)
.
Pulmonary
exacerbations
lead
to
impaired
lung
function
,
worse
quality
of
life
,
and
shorter
survival
.
We
hypothesized
that
aggressive
early
treatment
of
acute
pulmonary
exacerbation
may
improve
clinical
outcomes
.
Describe
the
rationale
of
an
ongoing
trial
designed
to
determine
the
efficacy
of
home
monitoring
of
both
lung
function
measurements
and
symptoms
for
early
detection
and
subsequent
early
treatment
of
acute
CF
pulmonary
exacerbations
.
A
randomized
,
non-blinded
,
multi-center
trial
in
320
individuals
with
CF
aged
14
years
and
older
.
The
study
compares
usual
care
to
a
twice
a
week
assessment
of
home
spirometry
and
CF
respiratory
symptoms
using
an
electronic
device
with
data
transmission
to
the
research
personnel
to
identify
and
trigger
early
treatment
of
CF
pulmonary
exacerbation
.
Participants
will
be
enrolled
in
the
study
for
12
months
.
The
primary
endpoint
is
change
in
FEV
1
(
L
)
from
baseline
to
12
months
determined
by
a
linear
mixed
effects
model
incorporating
all
quarterly
FEV
1
measurements
.
Secondary
endpoints
include
time
to
first
acute
protocol-defined
pulmonary
exacerbation
,
number
of
acute
pulmonary
exacerbations
,
number
of
hospitalization
days
for
acute
pulmonary
exacerbation
,
time
from
the
end
of
acute
pulmonary
exacerbation
to
onset
of
subsequent
pulmonary
exacerbation
,
change
in
health
related
quality
of
life
,
change
in
treatment
burden
,
change
in
CF
respiratory
symptoms
,
and
adherence
to
the
study
protocol
.
This
study
is
a
first
step
in
establishing
alternative
approaches
to
the
care
of
CF
pulmonary
exacerbations
.
We
hypothesize
that
early
treatment
of
pulmonary
exacerbations
has
the
potential
to
slow
lung
function
decline
,
reduce
respiratory
symptoms
and
improve
the
quality
of
life
for
individuals
with
CF
.
Diseases
Validation
Diseases presenting
"and adherence to the study protocol"
symptom
allergic bronchopulmonary aspergillosis
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