COPDNCT04236076
Assessing Exercise Capacity After PulseHaler™ Treatment in GOLD II-IV COPD Patients
A study testing PulseHaler in people with COPD, run by Respinova LTD.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- COPD
- What is being tested?
- PulseHaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- May 2020to Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
Cliff Annsel contact
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- PulseHaler, Sham - control
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| PulseHaler™ | Experimental | Patients will receive PulseHaler for home treatment Receives: Device: PulseHaler |
| Sham PulseHaler - CONTROL group | Sham comparator | Patients will receive Sham device for home treatment Receives: Device: Sham - control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
Change from baseline in duration of constant work rate exercise testing (TLIM)
Measured: at day 29
Secondary outcomes (12)
Pulmonary functions test- FEV1
Change from baseline in Forced Expiratory Volume in 1 Second (FEV1)
Measured: at day 29 and 43
Pulmonary functions test- FRC
Change from baseline in Functional Residual Capacity (FRC)
Measured: 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)
Measured: at day 29 and 43
Pulmonary functions test- FVC
Change from baseline in Forced Vital Capacity (FVC)
Measured: at day 29 and 43
COPD Assessment Test (CAT)
Change from baseline in score on CAT
Measured: at day 29 and 43
Patients compliance rate to treatment
Compliance rate and treatment timings self-reported through subject diaries
Measured: 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)
Measured: at day 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- VE
Changes from baseline in Expired Ventilation (VE)
Measured: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- HR
Changes from baseline in Hart Rate (HR)
Measured: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2
Changes from baseline in Peripheral capillary oxygen saturation (SpO2)
Measured: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- VT
Changes from baseline in Tidal Volume (VT)
Measured: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- RR
Changes from baseline in Respiration Rate (RR)
Measured: at day 29 and 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study startMay 2020 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respinova LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander Yarmolovsky, MD, Principal investigator, Kaplan Medical Center, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236076
- Sponsor's protocol ID
- PH-03
- Status last verified
- Dec 2019
- First submitted
- 18 Dec 2019
- Last updated
- 17 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Exercise Capacity After PulseHaler™ Treatment in Chronic Obstructive Lung Disease (GOLD) II-IV of Chronic Obstructive Pulmonary Disease (COPD) Patients
- ClinicalTrials.gov ID
- NCT04236076
- Acronym / sponsor ID
- PH-03
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Respinova LTDIndustry (pharma, biotech, devices)
- Study start
- May 2020 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 22 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PulseHaler™ | Experimental | Device: PulseHalerPatients will receive PulseHaler for home treatment |
| Sham PulseHaler - CONTROL group | Sham comparator | Device: Sham - controlPatients will receive Sham device for home treatment |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PulseHalerPulseHaler™ 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. | Device | PulseHaler™ |
| Sham - controlSham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components. | Device | Sham PulseHaler - CONTROL group |
Primary outcome
Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer
Time frame: at day 29
Change from baseline in duration of constant work rate exercise testing (TLIM)
12 secondary outcomes
Pulmonary functions test- FEV1
Time frame: at day 29 and 43
Pulmonary functions test- FRC
Time frame: at day 29 and 43
Pulmonary functions test - FEF25-75
Time frame: at day 29 and 43
Pulmonary functions test- FVC
Time frame: at day 29 and 43
COPD Assessment Test (CAT)
Time frame: at day 29 and 43
Patients compliance rate to treatment
Time frame: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- TLIM
Time frame: at day 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- VE
Time frame: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- HR
Time frame: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- SpO2
Time frame: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- VT
Time frame: at day 29 and 43
CWR Cardiopulmonary Exercise Test on cycle ergometer- RR
Time frame: at day 29 and 43
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cliff Annsel contact
Alexander Yarmolovsky, MD principal investigator
Kaplan Medical Center, Israel
Questions about this trial
What is this clinical trial studying?
A study testing PulseHaler in people with COPD, run by Respinova LTD.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dalia Givony, MSC (+972-54-5449235, dalia@respinova.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Constant Work Rate (CWR) Cardiopulmonary Exercise Test on cycle ergometer (time frame: at day 29). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2020.