COPD
Conditions
Brief summary
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
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.
Interventions
DEVICEPulseHaler
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.
DEVICESham - control
Sham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components.
Sponsors
Respinova LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer | at day 29 | Change from baseline in duration of constant work rate exercise testing (TLIM) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pulmonary functions test- FEV1 | at day 29 and 43 | Change from baseline in Forced Expiratory Volume in 1 Second (FEV1) |
| Pulmonary functions test- FRC | at day 29 and 43 | Change from baseline in Functional Residual Capacity (FRC) |
| Pulmonary functions test - FEF25-75 | at day 29 and 43 | Change from baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75) |
| Pulmonary functions test- FVC | at day 29 and 43 | Change from baseline in Forced Vital Capacity (FVC) |
| COPD Assessment Test (CAT) | at day 29 and 43 | Change from baseline in score on CAT |
| CWR Cardiopulmonary Exercise Test on cycle ergometer- VE | at day 29 and 43 | Changes from baseline in Expired Ventilation (VE) |
| CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM | at day 43 | Change from baseline in duration of constant work rate exercise testing (TLIM) |
| CWR Cardiopulmonary Exercise Test on cycle ergometer- HR | at day 29 and 43 | Changes from baseline in Hart Rate (HR) |
| CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2 | at day 29 and 43 | Changes from baseline in Peripheral capillary oxygen saturation (SpO2) |
| CWR Cardiopulmonary Exercise Test on cycle ergometer- VT | at day 29 and 43 | Changes from baseline in Tidal Volume (VT) |
| CWR Cardiopulmonary Exercise Test on cycle ergometer- RR | at day 29 and 43 | Changes from baseline in Respiration Rate (RR) |
| Patients compliance rate to treatment | at day 29 and 43 | Compliance rate and treatment timings self-reported through subject diaries |
Contacts
Primary ContactDalia Givony, MSC
Backup ContactCliff Annsel
Outcome results
None listed