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

Respinova

Status: Unknown

Conditions: COPD

Treatments: Device: Sham - control; Device: PulseHaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT04236076

PH-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 104 estimated patients

Sex: All

Ages: 55 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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104 participants in 2 patient groups

PulseHaler™

Experimental group

Description:

Patients will receive PulseHaler for home treatment

Treatment:

Device: PulseHaler

Sham PulseHaler - CONTROL group

Sham Comparator group

Description:

Patients will receive Sham device for home treatment

Treatment:

Device: Sham - control