High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)

The High Intensity Non-invasive Positive Pressure trial is a single arm interventional study.
The purpose of this study is to evaluate the effect of High Intensity Non-invasive
ventilation (HINPPV) in stable Chronic Obstructive Pulmonary patients with chronically
elevated carbon dioxide levels. Participants will undergo various testing ( arterial blood
gas (ABG), Pulmonary Function Test (PFTs), Polysomnography (PSGs), 6 minute walk tests)over a
3 month period to determine if this type of therapy will improve daytime carbon dioxide
levels. The participants will also complete quality of life questionnaires to help ascertain
improvements in their daily living activities.

Inclusion Criteria

1. Patient diagnosed with chronic obstructive pulmonary disease (COPD)

2. Age < or = to 80 years

3. Forced expiratory volume in one second (FEV1) < 50% of predicted value

4. FEV1/Forced vital capacity (FVC) < 70% of predicted value

5. Total lung capacity (TLC) > 90% predicted by plethysmography

6. Body Mass Index (BMI) < 35

7. Patient has provided written informed consent using a form that has been approved by
the Internal Review Board (IRB)

8. Daytime PaCO2 ≥ 52 mm Hg, at rest on room air (Denver > 48 mm Hg) with one of the
following symptoms of hypercapnia:

- Fatigue

- Sleepiness

- Headaches

9. Post hospital discharge at least one month prior to screening visit

10. Participant is willing and able to complete all required assessments and procedures

11. Participant has no child bearing potential OR a negative pregnancy test in a woman of
childbearing potential

Exclusion Criteria

1. FEV1 < 15% of predicted value

2. Diagnosis of obstructive sleep apnea (OSA) [Apnea hypopnea index (AHI) > 15 per hour]

3. Current Non-invasive Positive Pressure Ventilation (NIPPV), Positive Airway Pressure
(PAP) or Non-invasive Ventilation (NIV) users

4. Signs / symptoms of acute exacerbation within the previous month: two of the following
criteria:

- Increasing cough

- Purulent sputum

- Current use of antibiotics

- pH < 7.35

5. Any major non COPD disease or condition that interferes with completion of initial or
follow-up assessments, such as uncontrolled malignancy, end-stage heart disease, liver
or renal insufficiency (that requires current evaluation for liver or renal
transplantation or dialysis), amyotrophic lateral sclerosis, or severe stroke, or
other as deemed appropriate by investigator as determined by review of medical history
and / or patient reported medical history

6. History of pneumothorax

7. Anatomical facial abnormalities precluding placement of a nasal or facial mask

8. Diffuse parenchymal lung disease other than emphysema

9. Inability to maintain Oxygen (O2) saturation >90% on 5L/min ( five liters) nasal O2 at
rest

10. Sustained need for >10 mg prednisone daily or equivalent dose of other systemic
corticosteroid

11. Pregnancy

12. Excessive alcohol intake (≥ 6oz hard liquor daily), or illicit drug use

13. Daily use of narcotics (greater than 30 mg morphine equivalent)

14. Patient is currently enrolled in another interventional clinical trial