Clinical trial NCT04236076: Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients
Official title: Assessing Exercise Capacity After PulseHaler™ Treatment in Chronic Obstructive Lung Disease (GOLD) II-IV of Chronic Obstructive Pulmonary Disease (COPD) Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Lead sponsor: Respinova LTD
Sponsor class: INDUSTRY
First posted: 2020-01-22
Enrollment: 104
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
timeFrame: at day 29
Secondary outcomes:
measure: Pulmonary functions test- FEV1
timeFrame: at day 29 and 43
measure: Pulmonary functions test- FRC
timeFrame: at day 29 and 43
measure: Pulmonary functions test - FEF25-75
timeFrame: at day 29 and 43
measure: Pulmonary functions test- FVC
timeFrame: at day 29 and 43
measure: COPD Assessment Test (CAT)
timeFrame: at day 29 and 43
measure: Patients compliance rate to treatment
timeFrame: at day 29 and 43
measure: CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM
timeFrame: at day 43
measure: CWR Cardiopulmonary Exercise Test on cycle ergometer- VE
timeFrame: at day 29 and 43
measure: CWR Cardiopulmonary Exercise Test on cycle ergometer- HR
timeFrame: at day 29 and 43
measure: CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2
timeFrame: at day 29 and 43
measure: CWR Cardiopulmonary Exercise Test on cycle ergometer- VT
timeFrame: at day 29 and 43
measure: CWR Cardiopulmonary Exercise Test on cycle ergometer- RR
timeFrame: at day 29 and 43
Other outcomes:
Locations:
Study officials:
affiliation: Kaplan Medical Center, Israel
name: Alexander Yarmolovsky, MD
role: PRINCIPAL_INVESTIGATOR
References: