Pulmonary Disease, Chronic ObstructiveNCT00821418
Assessment of Treatment With PulseHaler on Patients With Chronic Obstructive Pulmonary Disease (COPD)
A study testing PulseHaler treatment and CPAP treatment (through a deactivated version of PulsHaler) in people with Pulmonary Disease, Chronic Obstructive, run by Respinova LTD at 1 site in Israel.
Trial summary
The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- PulseHaler treatment and CPAP treatment (through a deactivated version of PulsHaler)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2009to Feb 2010
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD
- Diagnosis established for at least 1 year;
- Post-bronchodilator FEV1/FVC < 0.7
- Post bronchodilator FEV1 <70% predicted
- Age: 40 years or older
- Smoking cigarettes, at least 10PY
- Patient signed the informed consent form
Who cannot join
- Bullous Emphysema (ruled out by recent CT)
- Hospitalization due to exacerbation of COPD within the last 3 months
- Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
- Systemic steroid treatment in the last 4 weeks
- Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
- Severe cardiac disease, e.g., CHF grade 3 or higher
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- Acute MI within last 3 months
- CABG within last 3 months
- Other severe systemic disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- PulseHaler treatment, CPAP treatment (through a deactivated version of PulsHaler)
- 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.
PulseHaler treatmentDevice
treatment is for two weeks, 3 times per day
CPAP treatment (through a deactivated version of PulsHaler)Device
treatment is for two weeks, 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| PulsHaler first | Experimental | Not described Receives: Device: PulseHaler treatment |
| Placebo first | Placebo comparator | Not described Receives: Device: CPAP treatment (through a deactivated version of PulsHaler) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary function tests
Measured: Within 2 hours from first treatment, and after 2 weeks of treatment
Six minute walk test
Measured: Within 2 hours from first treatment, and after 2 weeks of treatment
Health related quality of life
Measured: Within 2 hours from first treatment, and after 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2009 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respinova LTD
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00821418
- Sponsor's protocol ID
- PLS-01
- Status last verified
- May 2010
- First submitted
- 12 Jan 2009
- Last updated
- 11 May 2010
- Results posted
- No
Publications
Fridlender ZG, Arish N, Laxer U, Berkman N, Leibovitz A, Fink G, Breuer R. Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. COPD. 2012 Dec;9(6):603-10. doi: 10.3109/15412555.2012.748625. Epub 2012 Dec 6.
PubMed 23215916
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and the Effect on Patients With COPD of Treatment With PulseHaler™ - a Novel Device for Pulsating Positive Expiratory Pressure Ventilation
- ClinicalTrials.gov ID
- NCT00821418
- Acronym / sponsor ID
- PLS-01
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Respinova LTDIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 13 Jan 2009 (estimated)
- 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.
The purpose of the study is to assess the safety and the effect of treatment by PulseHaler™ on patients with COPD, as measured by the change from baseline in full pulmonary functions, oxygen saturation, exercise tolerance and health related quality of life; and to assess the ease of use of PulseHaler™ by the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PulsHaler first | Experimental | Device: PulseHaler treatment |
| Placebo first | Placebo comparator | Device: CPAP treatment (through a deactivated version of PulsHaler) |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of COPD
- Diagnosis established for at least 1 year;
- Post-bronchodilator FEV1/FVC < 0.7
- Post bronchodilator FEV1 <70% predicted
- Age: 40 years or older
Key exclusion criteria (9 listed)
- Bullous Emphysema (ruled out by recent CT)
- Hospitalization due to exacerbation of COPD within the last 3 months
- Upper respiratory infection and/or exacerbation of COPD in the last 4 weeks
- Systemic steroid treatment in the last 4 weeks
- Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
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 |
|---|---|---|
| PulseHaler treatmenttreatment is for two weeks, 3 times per day | Device | PulsHaler first |
| CPAP treatment (through a deactivated version of PulsHaler)treatment is for two weeks, 3 times per day | Device | Placebo first |
Primary outcome
Pulmonary function tests
Time frame: Within 2 hours from first treatment, and after 2 weeks of treatment
Six minute walk test
Time frame: Within 2 hours from first treatment, and after 2 weeks of treatment
Health related quality of life
Time frame: Within 2 hours from first treatment, and after 2 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2010.
- Derived from this study: PubMed 23215916Fridlender ZG, Arish N, Laxer U, Berkman N, Leibovitz A, Fink G, Breuer R. Randomized controlled crossover trial of a new oscillatory device as add-on therapy for COPD. COPD. 2012 Dec;9(6):603-10. doi: 10.3109/15412555.2012.748625. Epub 2012 Dec 6.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PulseHaler treatment and CPAP treatment (through a deactivated version of PulsHaler) in people with Pulmonary Disease, Chronic Obstructive, run by Respinova LTD at 1 site in Israel.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 11 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary function tests (time frame: Within 2 hours from first treatment, and after 2 weeks of treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00821418, which also lists 1 linked publication.
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 11 May 2010.