Chronic Obstructive Pulmonary DiseaseCPAPNCT01507844
Continuous Positive Airway Pressure Effect on Air Trapping in Chronic Obstructive Pulmonary Disease Patients
A study testing positive ventilation in people with Chronic Obstructive Pulmonary Disease, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- positive ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2009to Jun 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic obstructive lung disease stage 2-3 GOLD
- FRC > 120%
Who cannot join
- active ischemic heart disease
- heart failure
- peripheral vascular disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients
Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Pulmonary function tests including lung volumes at rest and and after exercise will be measured. In addition, exercise endurance time before treatment and after treatment will be measured.
Read the detailed description
Continuous positive airways pressure which prevent small air ways collapse and may also clear secretions. At first stage the optimal pressure for reducing air trapping will be determined. In addition, all patients will undergo a maximal exercise test. A baseline complete pulmonary function test is performed followed by continuous positive air way pressure at the pre-determined pressure. This will be followed by exercise at 60% of maximal obtained previously.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- positive ventilation
- Keywords
- COPD, CPAP, Sham, FEV1, IC, RV/TLC
- 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.
positive ventilationDevice
Also called CPAP
10 minutes of increased 4,7,12 positive pressure ventilation
| Study group | Role | What they receive |
|---|---|---|
| ventilation | Sham comparator | Not described Receives: Device: positive ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved small airways obstruction
Following CPAP ventilation measurement be repeated for 3 hrs
Measured: 2-3 hrs
Secondary outcomes (1)
improved respiratory symptoms
CAT score
Measured: 2-3 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startNov 2009
- Primary completionMar 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- David stav, MD, Principal investigator, Assaf-Harofeh Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01507844
- Sponsor's protocol ID
- 86/09
- Other IDs
- 12
- Acronym
- CPAP
- Status last verified
- Nov 2011
- First submitted
- 2 Nov 2009
- Last updated
- 11 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Positive Airway Pressure Effect on Air Trapping, Endurance Time in Chronic Obstructive Pulmonary Disease Patients
- ClinicalTrials.gov ID
- NCT01507844
- Acronym / sponsor ID
- CPAP / 86/09
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, CPAP, Sham, FEV1, IC, RV/TLC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- Nov 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Jan 2012 (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.
Chronic obstructive pulmonary disease is a disease characterized by small airways inflammation and obstruction. The small airways disease produces hyperinflation (air trapping), which increases with exercise. Continuous positive airways pressure may reduce small airways obstruction and therefore air trapping. Pulmonary function tests including lung volumes at rest and and after exercise will be measured. In addition, exercise endurance time before treatment and after treatment will be measured.
Detailed description
Continuous positive airways pressure which prevent small air ways collapse and may also clear secretions. At first stage the optimal pressure for reducing air trapping will be determined. In addition, all patients will undergo a maximal exercise test. A baseline complete pulmonary function test is performed followed by continuous positive air way pressure at the pre-determined pressure. This will be followed by exercise at 60% of maximal obtained previously.
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventilation | Sham comparator | Device: positive ventilation |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- chronic obstructive lung disease stage 2-3 GOLD
- FRC > 120%
Key exclusion criteria (3 listed)
- active ischemic heart disease
- heart failure
- peripheral vascular 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 |
|---|---|---|
| positive ventilationAlso: CPAP10 minutes of increased 4,7,12 positive pressure ventilation | Device | ventilation |
Primary outcome
improved small airways obstruction
Time frame: 2-3 hrs
Following CPAP ventilation measurement be repeated for 3 hrs
1 secondary outcome
improved respiratory symptoms
Time frame: 2-3 hrs
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 Jan 2012.
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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.
David stav, MD principal investigator
Assaf-Harofeh 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 positive ventilation in people with Chronic Obstructive Pulmonary Disease, run by Assaf-Harofeh Medical Center 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 2 inclusion and 3 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 Jan 2012. 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?
improved small airways obstruction (time frame: 2-3 hrs). 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 11 Jan 2012.