Assessing Exercise Capacity After PulseHaler™ Treatment in Chronic Obstructive Lung Disease (GOLD) II-IV of Chronic Obstructive Pulmonary Disease (COPD) Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Respinova LTD
- Enrollment
- 104
- Primary Endpoint
- Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
PulseHaler™
Patients will receive PulseHaler for home treatment
Intervention: PulseHaler (Device)
Sham PulseHaler - CONTROL group
Patients will receive Sham device for home treatment
Intervention: Sham - control (Device)
Outcomes
Primary Outcomes
Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
Time Frame: at day 29
Change from baseline in duration of constant work rate exercise testing (TLIM)
Secondary Outcomes
- COPD Assessment Test (CAT)(at day 29 and 43)
- Pulmonary functions test- FEV1(at day 29 and 43)
- Pulmonary functions test- FRC(at day 29 and 43)
- Pulmonary functions test - FEF25-75(at day 29 and 43)
- Pulmonary functions test- FVC(at day 29 and 43)
- Patients compliance rate to treatment(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM(at day 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- VE(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- HR(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- VT(at day 29 and 43)
- CWR Cardiopulmonary Exercise Test on cycle ergometer- RR(at day 29 and 43)