Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients
- Conditions
- COPD
- Registration Number
- NCT04236076
- Lead Sponsor
- Respinova LTD
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 104
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method COPD Assessment Test (CAT) at day 29 and 43 Change from baseline in score on CAT
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)
Patients compliance rate to treatment at day 29 and 43 Compliance rate and treatment timings self-reported through subject diaries
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- VE at day 29 and 43 Changes from baseline in Expired Ventilation (VE)
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)
CWR Cardiopulmonary Exercise Test on cycle ergometer- HR at day 29 and 43 Changes from baseline in Hart Rate (HR)