COPDNCT01187589
PulseHaler Drug Deposition Study in Chronic Obstructive Pulmonary Disease Patients
A study testing Pulsehaler and Nebulizer & Albuterol 0.5ml in people with COPD, run by Respinova LTD at 1 site in Israel.
Trial summary
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Pulsehaler and Nebulizer & Albuterol 0.5ml
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2010to Sep 2011
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
- Post-bronchodilator FEV1/FVC < 0.7
- Post-bronchodilator FEV1 in the range 30% - 70% predicted
- Age: 40 years or older
- Patient signed the informed consent form
Who cannot join
- Pneumothorax in the past, per anamnesis.
- Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
- Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
- Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
- Other severe systemic disease
- Non-cooperative or non-compliant patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
- Conditions
- COPD
- Being tested
- Pulsehaler, Nebulizer & Albuterol 0.5ml
- 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
Nebulizer & Albuterol 0.5mlDrug
Albuterol aerosolized by a nebulizer
| Study group | Role | What they receive |
|---|---|---|
| Pulsehaler | Experimental | Fully operational Pulsehaler, with protocol enabled Receives: Device: Pulsehaler; Drug: Nebulizer & Albuterol 0.5ml |
| Nebulizer | Active comparator | Deactivated Pulsehaler (protocol disabled), so only the nebulizer is active Receives: Drug: Nebulizer & Albuterol 0.5ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung deposition
Lung deposition of the albuterol-containing aerosol
Measured: 1 hour
Pulmonary functions
Pulmonary function tests by spirometry
Measured: 1 hour
Secondary outcomes (1)
Dyspnea
Dyspnea measured by the modified Borg scale
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2011
- Study completionSep 2011
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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Respinova LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Haim Golan, MD, Principal investigator, Assaf Harofe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01187589
- Sponsor's protocol ID
- PLS-02
- Status last verified
- Sep 2011
- First submitted
- 23 Aug 2010
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Assessment of the Effect of PulseHaler™ With Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
- ClinicalTrials.gov ID
- NCT01187589
- Acronym / sponsor ID
- PLS-02
- Conditions
- COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Respinova LTDIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 24 Aug 2010 (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.
This study is aimed at finding the effect of PulseHaler™ with Albuterol on Lung Deposition of Aerosol and on Pulmonary Functions in COPD Patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulsehaler | Experimental | Device: Pulsehaler, Drug: Nebulizer & Albuterol 0.5mlFully operational Pulsehaler, with protocol enabled |
| Nebulizer | Active comparator | Drug: Nebulizer & Albuterol 0.5mlDeactivated Pulsehaler (protocol disabled), so only the nebulizer is active |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Chronic Obstructive Pulmonary Disease (COPD), established for at least 1 year
- Post-bronchodilator FEV1/FVC < 0.7
- Post-bronchodilator FEV1 in the range 30% - 70% predicted
- Age: 40 years or older
- Patient signed the informed consent form
Key exclusion criteria (6 listed)
- Pneumothorax in the past, per anamnesis.
- Women at the age of fertility, who are pregnant, or plan pregnancy, or do not use contraceptive.
- Severe cardiac disease, e.g., Congestive Heart Failure (CHF) grade 3 or higher
- Coronary Artery Bypass Graft (CABG) or Acute Myocardial Infarction (MI) within last 3 months
- Other severe systemic disease
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 | Device | Pulsehaler |
| Nebulizer & Albuterol 0.5mlAlbuterol aerosolized by a nebulizer | Drug | Nebulizer, Pulsehaler |
Primary outcome
Lung deposition
Time frame: 1 hour
Lung deposition of the albuterol-containing aerosol
Pulmonary functions
Time frame: 1 hour
Pulmonary function tests by spirometry
1 secondary outcome
Dyspnea
Time frame: 1 hour
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 23 Sep 2011.
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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.
Haim Golan, MD principal investigator
Assaf Harofe Medical Center
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 and Nebulizer & Albuterol 0.5ml in people with COPD, 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 5 inclusion and 6 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 23 Sep 2011. 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. 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?
Lung deposition (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 23 Sep 2011.