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

Assessing Exercise Capacity After PulseHaler™ Treatment in Chronic Obstructive Lung Disease (GOLD) II-IV of Chronic Obstructive Pulmonary Disease (COPD) Patients

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.

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Device: PulseHaler; Device: Sham - control

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 Type: Interventional
• Enrollment (Anticipated): 104
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PulseHaler™; Patients will receive PulseHaler for home treatment	Device: PulseHaler; PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD. PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies, ranging from 3.5 Hertz (Hz) to 55Hz, and for pre-defined lengths of time.
Sham Comparator: Sham PulseHaler - CONTROL group; Patients will receive Sham device for home treatment	Device: Sham - control; Sham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer	Change from baseline in duration of constant work rate exercise testing (TLIM)	at day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pulmonary functions test- FEV1	Change from baseline in Forced Expiratory Volume in 1 Second (FEV1)	at day 29 and 43
Pulmonary functions test- FRC	Change from baseline in Functional Residual Capacity (FRC)	at day 29 and 43
Pulmonary functions test - FEF25-75	Change from baseline in Forced Expiratory Flow Between 25% and 75% of Forced Vital Capacity (FEF25-75)	at day 29 and 43
Pulmonary functions test- FVC	Change from baseline in Forced Vital Capacity (FVC)	at day 29 and 43
COPD Assessment Test (CAT)	Change from baseline in score on CAT	at day 29 and 43
Patients compliance rate to treatment	Compliance rate and treatment timings self-reported through subject diaries	at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM	Change from baseline in duration of constant work rate exercise testing (TLIM)	at day 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- VE	Changes from baseline in Expired Ventilation (VE)	at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- HR	Changes from baseline in Hart Rate (HR)	at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2	Changes from baseline in Peripheral capillary oxygen saturation (SpO2)	at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- VT	Changes from baseline in Tidal Volume (VT)	at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- RR	Changes from baseline in Respiration Rate (RR)	at day 29 and 43

Collaborators and Investigators

• Sponsor: Respinova LTD
• Investigators: Principal Investigator: Alexander Yarmolovsky, MD, Kaplan Medical Center, Israel

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: January 16, 2020
• First Posted (Actual): January 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 16, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PH-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No