Clinical Trials Logo

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world.

This study is designed to detect COPD participants with Expiratory Flow Limitation. EFL occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway.

Participants will undergo study eligibility procedures at visit 1. At visit 2 participants will undergo a baseline auto-EPAP (Expiratory Positive Airway Pressure) measurement. Then the order will be randomized to three different treatment methods. Between each treatment there will be at least a 10 minute washout period in order for CO2 to stabilize and return to baseline.


Clinical Trial Description

Chronic Obstructive Pulmonary Disease (COPD) is a major cause of chronic morbidity and mortality throughout the world, being the fourth leading cause of death in the world.

COPD is a disease that results in varying degrees of dyspnea, or shortness of breath. Spirometry is a method of diagnosing COPD with the presence of a post bronchodilator FEV1 <80% of the predicted value in combination with an FEV1 / FVC <70%. This would confirm that there is a presence of airflow limitation that is not fully reversible.

The presence of airflow limitation has been identified as one of the main causes of dyspnea in patients with chronic obstructive pulmonary disease (1). Expiratory Flow Limitation (EFL) occurs when the airways become compressed which usually results when a pressure outside the airway exceeds the pressure inside the airway. As an airflow obstruction worsens, EFL appears at much lower flows for a given lung volume and it becomes present at rest or at least develops early during exercise (2).

Early detection of EFL consisted of either invasive balloon catheterization or relatively complex plethysmographic techniques. An alternative approach, and one that will be used in this study, involves utilizing the Forced Oscillation Technique (FOT).

Alternatively High Frequency Oscillations (HFO) has shown to effectively lower CO2 levels, but traditionally require intubation or a trans tracheal catheter. Treatment with a specialized noninvasive ventilator is possible and it is proposed that therapy can be augmented by the application of an optimized EPAP to splint open the lower airways in order to increase the diffusive capabilities of the high frequency oscillations into lower alveolar regions. There are approximately 25 million hypercapnic patients with EFL that could benefit from this therapy. High frequency oscillations integrated into a specialized noninvasive ventilator has the advantages of lower cost than other solutions and significantly lower medical risks. In addition, high frequency oscillation uses lower pressures to achieve effective therapy which means less chance of barotrauma and greater patient acceptance.

This study will enroll subjects at a screening visit. Screening will include a physical exam and vital signs, pregnancy test (if applicable), questionnaires, pulse oximetry, measure of carbon dioxide levels, determination of EFL by an auto- Expiratory Positive Airway Pressure (EPAP) ventilator, and spirometry.

If the patient is eligible and tolerates the above procedures, they will be asked to complete an in home-based sleep study prior to visit 2. Alice Night One/ Alice PDX are portable home sleep testing devices that record information about breathing.

At visit 2 participants will be monitored continuously via a 3 lead EKG, oxygen saturation by pulse oximetry (SPO2), Carbon Dioxide concentration(TcCO2) monitor, RespiTrace belt and ventilator data.

During Visit 2, participants will first undergo a repeat optimal EPAP determination and then trial 3 different sessions of High Frequency Oscillation (HFO) therapy for 20 minutes with at least a 10 minute wash out period between each session to allow the participant's CO2 to stabilize or return to baseline. The order of the sessions will be randomized for each patient. Participants will be placed in a semi-recumbent position and wear a nasal CPAP mask for each session. A TcCO2 monitor patch will be placed on the skin (forehead area) to collect carbon dioxide measurements during each session. A RespiTrace belt will placed on the participants' chest wall to measure chest wall and diaphragmatic excursion during each session. A 3 lead EKG will also be used to monitor cardiac activity during each session. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02680639
Study type Interventional
Source Philips Respironics
Contact
Status Terminated
Phase N/A
Start date November 13, 2015
Completion date August 24, 2016

See also
  Status Clinical Trial Phase
Completed NCT05102305 - A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
Completed NCT01867762 - An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease Phase 2
Recruiting NCT05562037 - Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03089515 - Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust N/A
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Recruiting NCT05552833 - Pulmonary Adaptive Responses to HIIT in COPD N/A
Recruiting NCT05835492 - A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
Recruiting NCT05631132 - May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases? N/A
Completed NCT03244137 - Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
Not yet recruiting NCT03282526 - Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease N/A
Completed NCT02546700 - A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 2
Withdrawn NCT04446637 - Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD Phase 3
Completed NCT04535986 - A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD Phase 3
Recruiting NCT05865184 - Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
Completed NCT03295474 - Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
Completed NCT03256695 - Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD) Phase 3
Withdrawn NCT04042168 - Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD) Phase 4
Completed NCT03414541 - Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease Phase 2
Completed NCT02552160 - DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy