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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04236076
• Other study ID #: PH-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2020
• Est. completion date: June 2021

Study information

• Verified date: December 2019
• Source: Respinova LTD
• Contact: Dalia Givony, MSC
• Phone: +972-54-5449235
• Email: dalia[@]respinova.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 104
• Est. completion date: June 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD

Intervention

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 - 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Respinova LTD

Outcome

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