Chronic Obstructive Pulmonary DiseaseNCT00800072
NOWOX Oxygen Therapy Monitoring Device
A study testing NOWOX in people with Chronic Obstructive Pulmonary Disease, run by Air Liquide SA at 1 site in France.
Trial summary
The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- NOWOX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patient aged ≥ 18 years and ≤ 75 years,
- Having a documented diagnosis of moderately severe to severe chronic obstructive respiratory disease
- Hospitalised or out-patient requiring transient or long term oxygen therapy,
- Able to be weaned from oxygen for several consecutive minutes (around 30 minutes, SpO2 at rest on room air should not drop < 85%),
- Able to read
- Willing and able to complete the requirements of this study including providing his/her signature for the written informed consent.
Who cannot join
- Clinically unstable patient,
- Any contraindication to perform a light cycling exercise, according to the 2003 ATS/ACCP guidelines
- Tracheostomy,
- Nasal obstruction or acute rhinitis occurring in the week prior to selection,
- For female patient:
- Pregnant,
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- Positive urinary pregnancy test
- Lactating mother or lack of efficient contraception
- Clinically significant or uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, autoimmune, neurological or psychiatric disorders which may interfere with the study procedures,
- Known allergic reactions to medical material compounds used in the study
- Drug abuse or psychic disorders
- Legal status which prohibits informed consent,
- Participation in any interventional clinical trial within 30 days prior to selection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy
The purpose of this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy.
Read the detailed description
Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients with severe lung disease. This continuous or sub-continuous oxygen supplementation is generally introduced at home in patients who have chronic cardio respiratory failure and severe resting hypoxemia to maintain sufficient blood oxygenation and therefore preserve vital organ function.
LTOT effectiveness has mainly been evaluated and documented in patients with COPD, which also accounts for most of its prescriptions. In these patients, LTOT has been shown to have a beneficial impact on haemodynamics, exercise capacity, lung mechanics and mental state. Its implementation was furthermore associated with reduced yearly hospitalisation days and increased survival Measuring adherence is an extremely important and under-evaluated component of oxygen therapy. NOWOX, medical device has been designed,developed and manufactured to measure adherence to LTOT and additionally to measure patient's respiration rate
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- NOWOX
- Keywords
- to verify accurrancy of data collected by the NOWOX
- 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.
NOWOXDevice
one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours
| Study group | Role | What they receive |
|---|---|---|
| oxygen therapy | Experimental | one experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours Receives: Device: NOWOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary performance criterion is the overall estimated duration of oxygen use
Measured: 6 hours
Secondary outcomes (2)
secondary performance criterion: instantaneous respiration rate recorded by the NOWOX
Measured: 6 hours
secondary performance criterion: patient's satisfaction questionnaire on the NOWOX
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 posted1 Dec 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2010
- Study completionFeb 2010
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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Liquide SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anh-Tuan DINH-XUAN, Professor-MD, Principal investigator, Department of Physiology - Cochin University Hospital - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00800072
- Sponsor's protocol ID
- ALMED-07-MD-015
- Status last verified
- Feb 2014
- First submitted
- 28 Nov 2008
- Last updated
- 27 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NOWOX: a Medical Device Developed to Record Duration of Oxygen Use and Respiration Rate in Patients Requiring Oxygen Therapy
- ClinicalTrials.gov ID
- NCT00800072
- Acronym / sponsor ID
- ALMED-07-MD-015
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- to verify accurrancy of data collected by the NOWOX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Air Liquide SAIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Dec 2008 (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 this study is to evaluate the duration of oxygen use recorded by the NOWOX, under usual conditions of daily living, in patients with chronic obstructive respiratory disease requiring oxygen therapy.
Detailed description
Long Term Oxygen Therapy (LTOT) is one of the main non pharmacologic treatments for patients with severe lung disease. This continuous or sub-continuous oxygen supplementation is generally introduced at home in patients who have chronic cardio respiratory failure and severe resting hypoxemia to maintain sufficient blood oxygenation and therefore preserve vital organ function.
LTOT effectiveness has mainly been evaluated and documented in patients with COPD, which also accounts for most of its prescriptions. In these patients, LTOT has been shown to have a beneficial impact on haemodynamics, exercise capacity, lung mechanics and mental state. Its implementation was furthermore associated with reduced yearly hospitalisation days and increased survival Measuring adherence is an extremely important and under-evaluated component of oxygen therapy. NOWOX, medical device has been designed,developed and manufactured to measure adherence to LTOT and additionally to measure patient's respiration rate
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| oxygen therapy | Experimental | Device: NOWOXone experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patient aged ≥ 18 years and ≤ 75 years,
- Having a documented diagnosis of moderately severe to severe chronic obstructive respiratory disease
- Hospitalised or out-patient requiring transient or long term oxygen therapy,
- Able to be weaned from oxygen for several consecutive minutes (around 30 minutes, SpO2 at rest on room air should not drop < 85%),
- Able to read
Key exclusion criteria (13 listed)
- Clinically unstable patient,
- Any contraindication to perform a light cycling exercise, according to the 2003 ATS/ACCP guidelines
- Tracheostomy,
- Nasal obstruction or acute rhinitis occurring in the week prior to selection,
- For female patient:
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 |
|---|---|---|
| NOWOXone experimental device assigned to each of the 10 patients including in the study for an experiemental session duration of 6 hours | Device | oxygen therapy |
Primary outcome
Primary performance criterion is the overall estimated duration of oxygen use
Time frame: 6 hours
2 secondary outcomes
secondary performance criterion: instantaneous respiration rate recorded by the NOWOX
Time frame: 6 hours
secondary performance criterion: patient's satisfaction questionnaire on the NOWOX
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 27 Feb 2014.
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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.
Anh-Tuan DINH-XUAN, Professor-MD principal investigator
Department of Physiology - Cochin University Hospital - FRANCE
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NOWOX in people with Chronic Obstructive Pulmonary Disease, run by Air Liquide SA at 1 site in France.
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 13 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 27 Feb 2014. 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 France. 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?
Primary performance criterion is the overall estimated duration of oxygen use (time frame: 6 hours). 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 27 Feb 2014.