Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatments high intensity non invasive pos. pressure, bilevel positive airway pressure (bipap)
Sponsor Philips Respironics
Start date August 2010
End date December 2012
Trial size 20 participants
Trial identifier NCT01214200, HRC-0927-HINPPV-MS

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
The High Intensity Non-invasive Pos.Pressure trial is a single arm interventional study. All participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation (HINPPV). Participants will receive HINPPV via bilevel positive airway pressure (BiPAP) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
high intensity non invasive pos. pressure
High Intensity Non Invasive Positive Pressure Ventilation (HINPPV) will be applied to hypercapnic chronic obstructive pulmonary disease (COPD) patients for a period of 3 months. The Respironics bilevel positive airway pressure (BiPAP) Synchrony device has a maximum inspiratory positive airway pressure (IPAP) setting of 30 cmH2O and will be used for all participants in the study. If it is determined through the titration study the participant requires an IPAP greater than 30 cmH2O, they will be placed on the Respironics Trilogy ventilator.
bilevel positive airway pressure (bipap)
This is a single arm interventional study. All participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation(HINPPV). Participants will receive HINPPV via bilevel positive airway pressure (BiPAP) if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.

Primary Outcomes

Measure
Daytime partial pressure of carbon dioxide in arterial blood (PaCO2)
time frame: Before and after 3 months of therapy

Secondary Outcomes

Measure
Health Status
time frame: Before and after 3 months of therapy
Duration, Efficiency and Quality of Sleep and Sleepiness
time frame: Before and after 3 months of therapy
Maximal Inspiratory Pressure
time frame: Before and after 3 months of therapy
Exercise Capacity
time frame: Before and after 3 months of therapy
Dyspnea at rest and with exertion
time frame: Before and after 3 months of therapy

Eligibility Criteria

Male or female participants up to 80 years old.

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 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

Additional Information

Official title High Intensity Non-Invasive Positive Pressure Ventilation (HINPPV) for Stable Hypercapnic Chronic Obstructive Pulmonary Disease (COPD) Patients
Principal investigator Gerald Criner, MD
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 ( ABGs, PFTs, 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Philips Respironics.