Clinical trial NCT01214200: High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV)
Official title: High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2010-10-04
Enrollment: 20
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to evaluate the effect of high intensity non-invasive positive pressure ventilation (HINPPV) for stable, hypercapnic COPD patients. The investigators believe that HINPPV, used at least 6 hours nocturnally over three months, will benefit the stable hypercapnic COPD patient through a reduction in the daytime partial pressure of carbon dioxide in arterial blood (PaCO2) levels.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Daytime Partial Pressure of Carbon Dioxide in Arterial Blood (PaCO2)
timeFrame: Before and after 3 months of therapy
Secondary outcomes:
measure: Health Status
timeFrame: Before and after 3 months of therapy
measure: Maximal Inspiratory Pressure
timeFrame: Before and after 3 months of therapy
measure: Exercise Capacity
timeFrame: Before and after 3 months of therapy
measure: Dyspnea at Rest and With Exertion
timeFrame: Before and after 3 months of therapy
measure: Sleepiness
timeFrame: Before and after 3 months of therapy
measure: Duration of Sleep
timeFrame: Before and after 3 months of therapy
measure: Efficiency of Sleep
timeFrame: Before and after 3 months of therapy
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple Medical Center
name: Gerald Criner, MD
role: PRINCIPAL_INVESTIGATOR
References: