The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy

SPECIFIC AIMS/OBJECTIVES To determine whether the patients with chronic respiratory
sufficiency can benefit from the AIRVO warm humidifier by decreasing the number of
exacerbations. Furthermore, to determine the efficacy of warm humidification oxygen therapy
compared to dry oxygen therapy, in short-term and long-term treatment of patients with stage
II-IV COPD.

Primary Objective:

To observer and compare the exacerbation frequency between the warm humidification oxygen
therapy group and dry oxygen therapy group.

Secondary Objective:

Compare the number of exacerbation days, median time to first exacerbation, hospital
readmissions, and antibiotic use pertaining to respiratory infections with the baseline
values. Evaluate and compare the quality of life to the baseline measurements.

STUDY OVERVIEW

Methods:

The study will be conducted as an open label, non-randomized trial. Patients will be
assigned to AIRVO humidification if they meet all of the inclusion/exclusion criteria of the
study. All of the study participants will have the AIRVO warm humidifier installed at their
home as a stand alone unit or in addition to their current LTOT therapy. For the patients
that are already on LTOT, the oxygen flow setting will be increased to 20-25 l/min, to the
optimum flow by taking in consideration the patient's preference.

Data:

Data to be collected includes exacerbation frequency, number of exacerbation days, and time
to first exacerbation, pulmonary functions test, antibiotic usage and Quality of Life
assessment.

Description of AIRVO:

The AIRVO is for the treatment of spontaneously breathing patients who would benefit from
receiving high flow warmed and humidified respiratory gases. The AIRVO humidifier has
adjustable flow setting for delivery of fully saturated breathing gases at 37°C, 100%
humidity.

Flow rates on the humidifier are adjustable between 10 and 60 L/min for this specific
population (general is 2 -60 L/min). AIRVO humidifier is intended to be used in combination
with medical oxygen supply. When coupled to a medical oxygen supply, the regulation of
oxygen concentration is ensured, allowing for treatment of COPD patients with greater oxygen
flow without risking an increased accumulation of carbon dioxide. The mixed gases,
atmospheric air and with medical oxygen, pass through a humidification chamber with sterile
water for humidification and heating. Breathing tubes are equipped with spiral wire, this
aids with heating and ensures the uniform temperature and humidity is maintained. The air is
supplied to the patients at 37°C, 100% humidity. [16]

Treatment groups:

ARIVO:

All of the patients that will be Selected to participate in the study will be given an AIRVO
humidifier by the study sponsor. Patients will be connected to and instructed in the use of
the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on
the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant
sensation due to high flow and to avoid push back in the system.

When acceptable flow rate has been established, it is recorded in the patient's folder. The
patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably
at night. Using the humidifier for a longer period of time is allowed. The total number of
hours the humidifier was operational will be recorded at the end of the study.

Inclusion Criteria:

Have stage II-IV COPD diagnosis Understand and accept oral and written information in
English Be capable of handling the AIRVO warm humidifier after instruction >18years of age

Exclusion Criteria:

- Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental
illness)

- Bronchiectasis without simultaneous COPD diagnosis

- Treatment with BiPAP in the home

- Affected level of consciousness

- Smoking status change during study period

- Inability to provided signed consent