Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients

Study Overview
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Brief Summary
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Prospective, sham controlled, interventional study to evaluate the extent to which PulseHaler improves the functional status of Chronic Obstructive Lung Disease (GOLD) II-IV Chronic obstructive pulmonary disease (COPD) patients.

Detailed Description
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PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD . PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies and for pre-defined lengths of time. The study is intended to evaluate the extent to which PulseHaler improves the functional status of GOLD II-IV COPD patients after 4 weeks of treatment 3x / day. And To evaluate the extent to which improvements are maintained over a subsequent 2 weeks when treatments are tapered to 1x daily.

Official Title
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Assessing Exercise Capacity After PulseHaler™ Treatment in Chronic Obstructive Lung Disease (GOLD) II-IV of Chronic Obstructive Pulmonary Disease (COPD) Patients

Conditions
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COPD

Intervention / Treatment
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* Device: PulseHaler
* Device: Sham - control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Investigator confirmation of GOLD II-IV COPD Successful completion of Incremental Exercise Test (IET) FEV1 < 60% predicted Post-bronchodilator FEV1/FVC ≤ 0.7 55-75 years old Signed informed consent by subject (required cognitive capacity) Exclusion Criteria: SpO2<80% at IET Unable to achieve a CWR test duration at visit 2 between 3 and 8 minutes Exercise limitation unrelated to diagnosis of COPD Systemic (oral, IV, IM) steroid use for acute exacerbation in the 30 days prior to screening Baseline CAT Score <10 Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptives Severe cardiac disease, e.g., Congestive Heart Failure grade , hemodynamic instability, Acute myocardial infarction within last 3 months Coronary artery bypass graft within last 3 months Epilepsy, raised intracranial pressure, acute sinusitis or nosebleed Pulmonary embolism, untreated air leaks, tension pneumothorax, bronchopleural fistula, active hemoptysis, pulmonary haemorrhage, Large pulmonary bullae, intrathoracic obstruction from tumor or foreign body Unhealed dental, head, neck, ear, nose & throat, thoracic or upper gastro-intestinal tract surgery or trauma Unhealed broken ribs Esophageal varices Anxiety, Depression, history of Mental illness Dependence on positive pressure ventilation (i.e. 24/7 non-invasive ventilation). Cannot perform spirometry Enrollment in another interventional study Any medical condition for which the investigator deems the subject unable to participate in the study

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PulseHaler™<br>Patients will receive PulseHaler for home treatment | Device: PulseHaler<br>* PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD. PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies, ranging from 3.5 Hertz (Hz) to 55Hz, and for pre-defined lengths of time.<br>|
| Sham Comparator: Sham PulseHaler - CONTROL group<br>Patients will receive Sham device for home treatment | Device: Sham - control<br>* Sham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer | Change from baseline in duration of constant work rate exercise testing (TLIM) | at day 29 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary functions test- FEV1 | Change from baseline in Forced Expiratory Volume in 1 Second (FEV1) | at day 29 and 43 | 
| Pulmonary functions test- FRC | Change from baseline in Functional Residual Capacity (FRC) | at day 29 and 43 | 
| Pulmonary functions test - FEF25-75 | Change from baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) | at day 29 and 43 | 
| Pulmonary functions test- FVC | Change from baseline in Forced Vital Capacity (FVC) | at day 29 and 43 | 
| COPD Assessment Test (CAT) | Change from baseline in score on CAT | at day 29 and 43 | 
| Patients compliance rate to treatment | Compliance rate and treatment timings self-reported through subject diaries | at day 29 and 43 | 
| CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM | Change from baseline in duration of constant work rate exercise testing (TLIM) | at day 43 | 
| CWR Cardiopulmonary Exercise Test on cycle ergometer- VE | Changes from baseline in Expired Ventilation (VE) | at day 29 and 43 | 
| CWR Cardiopulmonary Exercise Test on cycle ergometer- HR | Changes from baseline in Hart Rate (HR) | at day 29 and 43 | 
| CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2 | Changes from baseline in Peripheral capillary oxygen saturation (SpO2) | at day 29 and 43 | 
| CWR Cardiopulmonary Exercise Test on cycle ergometer- VT | Changes from baseline in Tidal Volume (VT) | at day 29 and 43 | 
| CWR Cardiopulmonary Exercise Test on cycle ergometer- RR | Changes from baseline in Respiration Rate (RR) | at day 29 and 43 |