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

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