Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients
NCT ID: NCT04236076
Last Updated: 2020-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
104 participants
INTERVENTIONAL
2020-05-31
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PulseHaler™
Patients will receive PulseHaler for home treatment
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 PulseHaler - CONTROL group
Patients will receive Sham device for home treatment
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
55 Years
75 Years
ALL
No
Sponsors
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Respinova LTD
INDUSTRY
Responsible Party
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Principal Investigators
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Alexander Yarmolovsky, MD
Role: PRINCIPAL_INVESTIGATOR
Kaplan Medical Center, Israel
Central Contacts
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Other Identifiers
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PH-03
Identifier Type: -
Identifier Source: org_study_id
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