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.
Age
55–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
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
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
Clareo Health | Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients
