COPDHHCOPDNCT02731872
The Effect of Oxygen Therapy With Airvo High-flow Heated Humidification
A study testing Airvo humidifier in people with COPD, run by Birgitte Schantz Laursen at 1 site in Denmark.
Trial summary
The purpose of our study is to establish whether domiciliary use of the Airvo warm passover humidifier can reduce the number of exacerbations in patients with respiratory insufficiency. Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in long term oxygen therapy (LTOT). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- COPD
- What is being tested?
- Airvo humidifier
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Sep 2017
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- have severe/very severe COPD diagnosis
- have had chronic respiratory insufficiency for at least 3 months and be in steady oxygen therapy (LTOT) with a minimal supplement of 1 litre of oxygen per minute for at least 16 hours per day
- understand and accept oral and written information in Danish
- be capable of handling the Airvo warm humidifier after instruction.
Who cannot join
- Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness)
- Bronchiectasis without simultaneous COPD diagnosis
- Treatment with BiPAP in the home
- Affected level of consciousness
- Smoking status change during project period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Oxygen Therapy With Airvo High-flow Heated Humidification for Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
The purpose of our study is to establish whether domiciliary use of the Airvo warm passover humidifier can reduce the number of exacerbations in patients with respiratory insufficiency. Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in long term oxygen therapy (LTOT). The following questions will be investigated:
Do outpatients receiving long term oxygen therapy benefit if this is delivered through an Airvo humidification system. The proposed benefits under investigation are:
- a reduction in the number of exacerbations and thus hospital admissions?
- an increase in quality of life (QOL)?
- an improved lung function and thus increased physical activity?
Read the detailed description
Experience at Aalborg University Hospital's Department of Pulmonary Medicine (Lungemedicinsk Afdeling) in Denmark gives rise to a renewed interest in the investigation of the properties and effects of humidification in COPD patients in LTOT. For the last 5 years, the department has discharged fibrosis patients with oxygen flow > 6 l/min with a warm mist humidifier. The initiative has given clear indication that infection ratios can be reduced and the QOL increased. Many COPD patients experience improved oxygen saturation when oxygen treatment for respiration insufficiency is given with warm humidification.
Previous studies have typically concerned other patient categories and involved the use of cold-water humidifiers. To increase air moistening, the temperature must be raised as moisture absorption capability increases with temperature. The 2009 study of Rea et al. (9) examined the effect of warm humidification on COPD and bronchiectasis patients, who used a warm humidifier (MR 880) on average for two hours per day. LTOT was not an inclusion criterion in the study, and the severity of COPD varied. Despite the relatively short time of use the study demonstrated the beneficial effect of humidification on exacerbation frequency.
Our study therefore aims to examine the effect of using warm humidification as a minimum during the night - preferably for 8 hours.
In addition to their usual oxygen apparatuses, the treatment group will have an Airvo warm humidifier installed in the home. Their respiratory gas flow setting will be increased to 20-25 l/min based on patient preference; then the peripheral saturation readings will form the basis for adjusting the oxygen flow rate.
The control group will continue receiving the standard oxygen therapy prescribed by the department.
For the study to achieve the desired power, 190-200 patients across the two groups are required Appendix 3). Patients must have been diagnosed with severe/very severe COPD and be receiving long-term domiciliary oxygen treatment (LTOT)
For all participants, the following procedure will be adhered to:
- Metrics at inclusion:
- Demographic data
- Pulmonary function measurement using spirometry
- Exacerbations (by number of)
- hospitalisation days in past year (data extracted from AS400)
- antibiotics courses and prednisolone courses in past year (from prescription database)
- exacerbations/self-treatment plans launched
- 6-minute walk test
- QOL measurement (St George's Respiratory Questionnaire)
- Artery puncture (Airvo group only)
- Metrics in project period at 1, 3, 6 and 9 months: Patients will be contacted by telephone on a date agreed in advance.
- QOL measurement (St George's Respiratory Questionnaire). Form completed only after 6 months; sent to patient in advance.
- Number of exacerbations/self-treatment plans launched
- Metrics at project period completion (at 12 months):
Patients will be called in for an outpatient visit to the department
- Pulmonary function measurement (spirometry)
- St George's Respiratory Questionnaire (sent to patient prior to interview)
- 6-minute walk test
- Exacerbations in project period (by number of)
- hospitalisation days in past year (data extracted from AS400)
- antibiotics courses and prednisolone courses in past year (from prescription database)
- exacerbations/self-treatment plans launched
Analysis and statistical processing of project data will be performed by statistician Hans Hockey of Biometricmatters Ltd, Hamilton, New Zealand. Power calculations based on anonymised data extracts from AS400 have already been performed.
Consultation with Mr Hockey has clarified that "events" and "visits" are synonymous terms. In the appendix the term "events" will be used, to indicate the number of contacts with the hospital.
According to Mr Hockey, risk time will be calculated as "the period of time for which a patient is at risk of the event being considered". Risk time thus corresponds to the time that the patient participates in the trial. The trial period is 12 months, but drop-out due to death or withdrawal for any other reasons is to be expected. All data will be included in the study, including data on dropouts.
This project protocol has been approved by the North Denmark Region scientific ethical committee (N-20110057).
- Conditions
- COPD
- Being tested
- Airvo humidifier
- Keywords
- COPD, oxygen treatment, quality of life
- 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.
Airvo humidifierDevice
The Airvo humidifier has adjustable flow settings for delivery of fully saturated breathing gases at 37 °C, 100% humidity.
Flow rates are adjustable between 15 and 45 l/min. Ambient air is drawn in by a low-capacity motor. When coupled to a medical oxygen supply, the regulation of delivered oxygen concentration is ensured.
| Study group | Role | What they receive |
|---|---|---|
| High Flow humidification system | Experimental | In addition to their usual oxygen apparatuses, the treatment group will have an Airvo humidifier system installed in the home. The supplied oxygen flow will be entrained along with room air through the Airvo humidification system. this combined respiratory gas will then be warmed and humidified and delivered to the patient via a nasal cannula. The total respiratory gas flow rate will be between 20-25 l/min, depending on participant´s preference. Then the oxygen fraction is adjusted until the subjects target oxygen saturation levels are achieved. Receives: Device: Airvo humidifier |
| Standard oxygen therapy | No intervention | The control group will continue receiving the standard oxygen therapy prescribed by the department |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of exacerbations and thus hospital admissions, based on data on hospital admissions.
Outcomes relating to exacerbations will be recorded according to GOLD COPD guidelines:
An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD (3).
At inclusion of the patient, the number of exacerbations (deterioration) in the last year, based on data on the need for antibiotics and/or prednisolone (corticosteroid), and hospital admissions will be registered. Data will be recorded via extracts from AS400 and the prescription database. To ensure data validity concerning redeemed prescriptions, patients will be asked about the number of self-treatment plans.
At project completion, the same metrics are recorded for the entire period.
Measured: one year
Secondary outcomes (3)
increase in quality of life, measured by St George's Respiratory Questionnaire (SGRQ),
All patients will be required to complete a health-related QOL questionnaire, the validated Danish version of the St George's Respiratory Questionnaire (SGRQ), see Appendix 1. Permission for use has been obtained from Professor Paul Jones, St George's University, London (Appendix 1).
The questionnaire will be completed at inclusion, 6 months and 12 months.
Measured: six month and one year
improved lung function, using Spida 5 equipment.
The test will be performed by the project responsible nurse, or her deputy, using Spida 5 equipment. FEV1 and FEV1/FVC are recorded for both study groups. To ensure uniform measurement methods, the department's instructions on spirometry measurements will be followed
Measured: one year
Improved physical ability, based on six-minute walk test.
The six-minute walk test, in which the patient walks as far as possible, will be used as a measure of functional work capacity. Patients will be encouraged to exert themselves. Any pauses will be included in the six minutes.
To ensure uniform measurement methods, the department's instructions on spirometry measurements will be followed
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2016 (estimated)
- Study startJan 2012
- Primary completionSep 2017
- Study completionSep 2017
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 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Birgitte Schantz Laursen
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, AGA The Linde Group
- Responsible party
- Sponsor-investigator, Birgitte Schantz Laursen, Aalborg University Hospital
- Investigators
- Ulla M Weinreich, MD, Study chair, Department for Pulmonary Medicine, Aalborg University Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731872
- Sponsor's protocol ID
- N-20110057
- Acronym
- HHCOPD
- Status last verified
- Jan 2018
- First submitted
- 14 Mar 2016
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Dansk Selskab for Almen Medicin. Klinisk vejledning: KOL i almen praksis - diagnostik, behandling, opfølgning, rehabilitering. 2008. Sundhedsstyrelsen: KOL - kronisk obstruktiv lungesygdom. Anbefalinger for tidlig opsporing, opfølgning, behandling og rehabilitering. 2007. Ringbæk, T, Taudorf, E, Overgaard, A, Sorknæs, A og Fabricius, P. Protokol for Iltbehandling i hjemmet. Dansk Lungemedicinsk Selskabs rekommandationer. 2006. Kampelmacher, MJ, Van Kesteren, RG, Alsbach, GPJ et al. Characteristics and complaints of patients prescribed long-term oxygen therapy in The Netherlands. Respiratory Medicine, 92, 70-75, 1998 Medicinsk Kompendium. Kap. 37 Lungesygdomme Cambell, EJ, Baker, MD, Crites-Silver, P. Subjective effects of humidification of oxygen for delivery by nasal cannula. A prospective study. Chest, 93, 289-293, 1988. Gorecka, D, Gorzelak, K, Sliwinski, P, Tobiasz, M, Zielinski, J. Effect of long term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia. Thorax, 52, 674-679, 1997. Rea, H, McAuley, S, Jayaram, L, Garrett, J, Hockey, H et al. The clinical utility of long-term humidification therapy in chronic airway disease. Respiratory Medicine, 104, 525-533, 2010. Fisher & Paykel Healthcare. Airvo. Hospital Use Operating Manual. Siggaard-Andersen, O, Gøthgen, IH, Wimberley, PD, Fogh-Andersen, N. The oxygen status of the arterial blood revised: relevant oxygen parameters for monitoring the arterial oxygen availability. Scand J Clinical Lab Invest, 50, suppl. 203, 17-28, 1990.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oxygen Therapy With Airvo High-flow Heated Humidification for Respiratory Insufficiency in Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT02731872
- Acronym / sponsor ID
- HHCOPD / N-20110057
- Conditions
- COPD
- Keywords
- COPD, oxygen treatment, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Birgitte Schantz LaursenUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare, AGA The Linde Group
- Study start
- Jan 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 8 Apr 2016 (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 our study is to establish whether domiciliary use of the Airvo warm passover humidifier can reduce the number of exacerbations in patients with respiratory insufficiency. Participants must have a diagnosis of chronic obstructive pulmonary disease (COPD) and be in long term oxygen therapy (LTOT). The following questions will be investigated:
Do outpatients receiving long term oxygen therapy benefit if this is delivered through an Airvo humidification system. The proposed benefits under investigation are:
- a reduction in the number of exacerbations and thus hospital admissions?
- an increase in quality of life (QOL)?
- an improved lung function and thus increased physical activity?
Detailed description
Experience at Aalborg University Hospital's Department of Pulmonary Medicine (Lungemedicinsk Afdeling) in Denmark gives rise to a renewed interest in the investigation of the properties and effects of humidification in COPD patients in LTOT. For the last 5 years, the department has discharged fibrosis patients with oxygen flow > 6 l/min with a warm mist humidifier. The initiative has given clear indication that infection ratios can be reduced and the QOL increased. Many COPD patients experience improved oxygen saturation when oxygen treatment for respiration insufficiency is given with warm humidification.
Previous studies have typically concerned other patient categories and involved the use of cold-water humidifiers. To increase air moistening, the temperature must be raised as moisture absorption capability increases with temperature. The 2009 study of Rea et al. (9) examined the effect of warm humidification on COPD and bronchiectasis patients, who used a warm humidifier (MR 880) on average for two hours per day. LTOT was not an inclusion criterion in the study, and the severity of COPD varied. Despite the relatively short time of use the study demonstrated the beneficial effect of humidification on exacerbation frequency.
Our study therefore aims to examine the effect of using warm humidification as a minimum during the night - preferably for 8 hours.
In addition to their usual oxygen apparatuses, the treatment group will have an Airvo warm humidifier installed in the home. Their respiratory gas flow setting will be increased to 20-25 l/min based on patient preference; then the peripheral saturation readings will form the basis for adjusting the oxygen flow rate.
The control group will continue receiving the standard oxygen therapy prescribed by the department.
For the study to achieve the desired power, 190-200 patients across the two groups are required Appendix 3). Patients must have been diagnosed with severe/very severe COPD and be receiving long-term domiciliary oxygen treatment (LTOT)
For all participants, the following procedure will be adhered to:
- Metrics at inclusion:
- Demographic data
- Pulmonary function measurement using spirometry
- Exacerbations (by number of)
- hospitalisation days in past year (data extracted from AS400)
- antibiotics courses and prednisolone courses in past year (from prescription database)
- exacerbations/self-treatment plans launched
- 6-minute walk test
- QOL measurement (St George's Respiratory Questionnaire)
- Artery puncture (Airvo group only)
- Metrics in project period at 1, 3, 6 and 9 months: Patients will be contacted by telephone on a date agreed in advance.
- QOL measurement (St George's Respiratory Questionnaire). Form completed only after 6 months; sent to patient in advance.
- Number of exacerbations/self-treatment plans launched
- Metrics at project period completion (at 12 months):
Patients will be called in for an outpatient visit to the department
- Pulmonary function measurement (spirometry)
- St George's Respiratory Questionnaire (sent to patient prior to interview)
- 6-minute walk test
- Exacerbations in project period (by number of)
- hospitalisation days in past year (data extracted from AS400)
- antibiotics courses and prednisolone courses in past year (from prescription database)
- exacerbations/self-treatment plans launched
Analysis and statistical processing of project data will be performed by statistician Hans Hockey of Biometricmatters Ltd, Hamilton, New Zealand. Power calculations based on anonymised data extracts from AS400 have already been performed.
Consultation with Mr Hockey has clarified that "events" and "visits" are synonymous terms. In the appendix the term "events" will be used, to indicate the number of contacts with the hospital.
According to Mr Hockey, risk time will be calculated as "the period of time for which a patient is at risk of the event being considered". Risk time thus corresponds to the time that the patient participates in the trial. The trial period is 12 months, but drop-out due to death or withdrawal for any other reasons is to be expected. All data will be included in the study, including data on dropouts.
This project protocol has been approved by the North Denmark Region scientific ethical committee (N-20110057).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High Flow humidification system | Experimental | Device: Airvo humidifierIn addition to their usual oxygen apparatuses, the treatment group will have an Airvo humidifier system installed in the home. The supplied oxygen flow will be entrained along with room air through the Airvo humidification system. this combined respiratory gas will then be warmed and humidified and delivered to the patient via a nasal cannula. The total respiratory gas flow rate will be between 20-25 l/min, depending on participant´s preference. Then the oxygen fraction is adjusted until the subjects target oxygen saturation levels are achieved. |
| Standard oxygen therapy | No intervention | –The control group will continue receiving the standard oxygen therapy prescribed by the department |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- have severe/very severe COPD diagnosis
- have had chronic respiratory insufficiency for at least 3 months and be in steady oxygen therapy (LTOT) with a minimal supplement of 1 litre of oxygen per minute for at least 16 hours per day
- understand and accept oral and written information in Danish
- be capable of handling the Airvo warm humidifier after instruction.
Key exclusion criteria (5 listed)
- Comorbidity (known malignant disease, terminal illness, dementia, uncontrolled mental illness)
- Bronchiectasis without simultaneous COPD diagnosis
- Treatment with BiPAP in the home
- Affected level of consciousness
- Smoking status change during project period.
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 |
|---|---|---|
| Airvo humidifierThe Airvo humidifier has adjustable flow settings for delivery of fully saturated breathing gases at 37 °C, 100% humidity. Flow rates are adjustable between 15 and 45 l/min. Ambient air is drawn in by a low-capacity motor. When coupled to a medical oxygen supply, the regulation of delivered oxygen concentration is ensured. | Device | High Flow humidification system |
Primary outcome
Reduction in the number of exacerbations and thus hospital admissions, based on data on hospital admissions.
Time frame: one year
Outcomes relating to exacerbations will be recorded according to GOLD COPD guidelines: An exacerbation of COPD is defined as an event in the natural course of the disease characterized by a change in the patient's baseline dyspnea, cough and/or sputum that is beyond normal day-to-day variations, is acute in onset, and may warrant a change in regular medication in a patient with underlying COPD (3). At inclusion of the patient, the number of exacerbations (deterioration) in the last year, based on data on the need for antibiotics and/or prednisolone (corticosteroid), and hospital admissions will be registered. Data will be recorded via extracts from AS400 and the prescription database. To ensure data validity concerning redeemed prescriptions, patients will be asked about the number of self-treatment plans. At project completion, the same metrics are recorded for the entire period.
3 secondary outcomes
increase in quality of life, measured by St George's Respiratory Questionnaire (SGRQ),
Time frame: six month and one year
improved lung function, using Spida 5 equipment.
Time frame: one year
Improved physical ability, based on six-minute walk test.
Time frame: one year
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 10 Jan 2018.
- BackgroundDansk Selskab for Almen Medicin. Klinisk vejledning: KOL i almen praksis - diagnostik, behandling, opfølgning, rehabilitering. 2008. Sundhedsstyrelsen: KOL - kronisk obstruktiv lungesygdom. Anbefalinger for tidlig opsporing, opfølgning, behandling og rehabilitering. 2007. Ringbæk, T, Taudorf, E, Overgaard, A, Sorknæs, A og Fabricius, P. Protokol for Iltbehandling i hjemmet. Dansk Lungemedicinsk Selskabs rekommandationer. 2006. Kampelmacher, MJ, Van Kesteren, RG, Alsbach, GPJ et al. Characteristics and complaints of patients prescribed long-term oxygen therapy in The Netherlands. Respiratory Medicine, 92, 70-75, 1998 Medicinsk Kompendium. Kap. 37 Lungesygdomme Cambell, EJ, Baker, MD, Crites-Silver, P. Subjective effects of humidification of oxygen for delivery by nasal cannula. A prospective study. Chest, 93, 289-293, 1988. Gorecka, D, Gorzelak, K, Sliwinski, P, Tobiasz, M, Zielinski, J. Effect of long term oxygen therapy on survival in patients with chronic obstructive pulmonary disease with moderate hypoxaemia. Thorax, 52, 674-679, 1997. Rea, H, McAuley, S, Jayaram, L, Garrett, J, Hockey, H et al. The clinical utility of long-term humidification therapy in chronic airway disease. Respiratory Medicine, 104, 525-533, 2010. Fisher & Paykel Healthcare. Airvo. Hospital Use Operating Manual. Siggaard-Andersen, O, Gøthgen, IH, Wimberley, PD, Fogh-Andersen, N. The oxygen status of the arterial blood revised: relevant oxygen parameters for monitoring the arterial oxygen availability. Scand J Clinical Lab Invest, 50, suppl. 203, 17-28, 1990.
- Individual participant dataSharing planned: No
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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.
Ulla M Weinreich, MD study chair
Department for Pulmonary Medicine, Aalborg University Hospital, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Airvo humidifier in people with COPD, run by Birgitte Schantz Laursen at 1 site in Denmark.
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 4 inclusion and 5 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 10 Jan 2018. 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 Denmark. 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?
Reduction in the number of exacerbations and thus hospital admissions, based on data on hospital admissions. (time frame: one year). 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 NCT02731872, 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 10 Jan 2018.