Chronic obstructive pulmonary disease (COPD) is characterized by respiratory
exacerbations which increase in frequency as the severity of the disease progresses. COPD
exacerbations may lead to hospitalizations, which make up the largest proportion of the
total direct health-care cost of the disease and are a significant burden for patients
and family. Chronic bronchitis, defined as chronic cough with sputum production for at
least 3 months a year for 2 consecutive years, is one of the clinical manifestations of
COPD. Chronic bronchitis doubles the risk of COPD exacerbations and hospitalizations, and
is associated with increased dyspnea, worse health-related quality of life, and poorer
quality of sleep. Chronic bronchitis also results in increased air trapping and
hyperinflation, which decreases exercise capacity. Unfortunately, other than traditional
inhaled pharmacological agents, there are no treatment options for COPD patients with
chronic bronchitis.
Heated, humidified high-flow air (HHHFA) devices improve airway clearance. HHHFA use for
an average of 1.6 hours a day in COPD patients with chronic bronchitis improves
health-related quality of life, lung function, and delays the first respiratory
exacerbation. However, HHHFA for an average of 1.6 hours a day had no effect on COPD
exacerbation frequency or hospitalization, dyspnea, or exercise capacity, likely due to
short duration of the treatment. Conversely, the effect of HHHFA for longer time periods
on chronic bronchitis patients has not been studied. Moreover, the effect of HHHFA on
sleep quality has not been studied. A prior study in COPD patients showed that use of
HHHFA for more than 7 hours during sleep can be achieved. The overall objective of this
research is to examine the effect of HHHFA during sleep on COPD patients with chronic
bronchitis. In this pilot study, the study team will examine the effect of HHHFA during
sleep on clinically relevant short-term outcomes including: respiratory symptoms, quality
of life and sleep, lung function and exercise capacity.
Hypothesis 1: HHHFA during sleep in COPD patients with chronic bronchitis improves
respiratory symptoms, sleep quality, lung function, and exercise capacity.
Aim 1: To examine the effect of HHHFA during sleep on respiratory symptoms, sleep
quality, lung function, and exercise capacity in COPD patients with chronic bronchitis.
The effect of HHHFA on air trapping and hyperinflation has not been studied. Air trapping
and hyperinflation as well as other radiographic measurements associated with chronic
bronchitis (e.g. airway wall thickness) can be measured using chest CT.
Hypothesis 2: HHHFA during sleep in COPD patients with chronic bronchitis improves air
trapping and hyperinflation.
Aim 2: To examine the effect of HHHFA in COPD patients with chronic bronchitis during
sleep on air trapping and hyperinflation through chest CT imaging.
Design: The study team will include COPD subjects with a post-bronchodilator
FEV1%predicted below 70% and chronic bronchitis. The study team will include subjects
with at least 2 exacerbations in the last year to identify patients with significant
burden due to chronic bronchitis. The study team will exclude subjects with recent
respiratory events or procedures as the study team want to capture the benefit of HHHFA
on chronic, stable COPD participants. Subjects who meet eligibility criteria will be
randomized to HHHFA or usual care (Controls). At baseline the study team will perform
measurements in all subjects that include dyspnea, cough, health-related quality of life,
sleep quality, spirometry, a 6-minute walk test, and chest CT. All subjects, from both
groups will also use the SPIREHEALTH Tag Device to measure their daily heart rate,
respiratory rate, patient activity and calories. The group that is randomized to use the
HHHFA device will be provided the HHHFA device at the baseline visit. Subjects will use
the device during sleep for 6 weeks and both the HHHFA arm and the control arm will
return for a 6 week follow up visit. At the 6 week follow up visit, participants will
repeat all baseline evaluations. The study team will compare variables (e.g. FEV1)
between baseline and 6-week visit in each treatment group. The study team will also
compare changes in those variables over time between groups. To evaluate the effect of
treatment between baseline and 6 weeks, the study team will use linear mixed effect
models controlling for demographics and lung function.
Subjects who have been using the HHHFA device will be asked to stop using the device for
the next 6 weeks. Both arms will then have a follow up phone call at the end of the 6
weeks (12 week follow up phone call visit). Subjects from both arms will continue to use
the SPIREHEALTH and that data will be collected for both arms during that 6 week period.
Subjects who were previously randomized to the HHHFA arm will be asked, at the 6 week
follow up visit, if they would be interested in participating in an optional sub-study
that would allow them to start using the HHHFA device again, after their 12 week follow
up phone call for an additional 36 weeks (for a total study involvement of 48 weeks) The
subjects will have follow up phone call visits at 24 weeks, 36 weeks, and 48 weeks.
Subjects who were randomized to the HHHFA device but do not want to keep using the device
will be given the option of continuing to participate but only will the follow up phone
call visits. Respiratory exacerbations information will be collected at these phone call
visits.