NCT04236076

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

April 17, 2020

Status Verified

December 1, 2019

Enrollment Period

1 year

First QC Date

December 18, 2019

Last Update Submit

April 16, 2020

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • 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

  • COPD Assessment Test (CAT)

    at day 29 and 43

  • +7 more secondary outcomes

Study Arms (2)

PulseHaler™

EXPERIMENTAL

Patients will receive PulseHaler for home treatment

Device: PulseHaler

Sham PulseHaler - CONTROL group

SHAM COMPARATOR

Patients will receive Sham device for home treatment

Device: Sham - control

Interventions

PulseHalerDEVICE

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.

PulseHaler™
Sham - controlDEVICE

Sham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components.

Sham PulseHaler - CONTROL group

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Investigator confirmation of GOLD II-IV COPD
  • Successful completion of Incremental Exercise Test (IET)
  • FEV1 \< 60% predicted
  • Post-bronchodilator FEV1/FVC ≤ 0.7
  • years old
  • Signed informed consent by subject (required cognitive capacity)

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Alexander Yarmolovsky, MD

    Kaplan Medical Center, Israel

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dalia Givony, MSC

CONTACT

+972-54-5449235dalia@respinova.com

Cliff Annsel

CONTACT

Cliff@respinova.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 18, 2019

First Posted

January 22, 2020

Study Start

May 1, 2020

Primary Completion

May 1, 2021

Study Completion

June 1, 2021

Last Updated

April 17, 2020

Record last verified: 2019-12