COPDNCT03081650
The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy
A study testing Airvo Humidifier in people with COPD and Chronic Obstructive Pulmonary Disease, run by Lutheran Hospital, Indiana at 1 site in United States.
Trial summary
The primary purpose of this study is to show whether at home usage of the AIRVO warm humidifier can potentially reduce the number of exacerbations in patients with significant respiratory insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COPD, Chronic Obstructive Pulmonary Disease
- 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
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Aug 2016to 1 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have stage II-IV COPD diagnosis Understand and accept oral and written information in English Be capable of handling the AIRVO warm humidifier after instruction >18years of age
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 study period
- Inability to provided signed consent
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Lutheran hospital
Fort Wayne, Indiana, 46804
Gordon Bokhart, Pharm D, 260-435-7718, gbokhart@lhn.net
Lisa Burris, RRT, CPFT, 260-435-7890, lburris@lhn.net
About this study
Official title: The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy as Well as Stand-alone Therapy in Patients With Respiratory Insufficiency
The primary purpose of this study is to show whether at home usage of the AIRVO warm humidifier can potentially reduce the number of exacerbations in patients with significant respiratory insufficiency. Eligible participants of the study must have a diagnosis of chronic obstructive pulmonary disease (COPD) stage II-IV..
Read the detailed description
SPECIFIC AIMS/OBJECTIVES To determine whether the patients with chronic respiratory sufficiency can benefit from the AIRVO warm humidifier by decreasing the number of exacerbations. Furthermore, to determine the efficacy of warm humidification oxygen therapy compared to dry oxygen therapy, in short-term and long-term treatment of patients with stage II-IV COPD.
Primary Objective:
To observer and compare the exacerbation frequency between the warm humidification oxygen therapy group and dry oxygen therapy group.
Secondary Objective:
Compare the number of exacerbation days, median time to first exacerbation, hospital readmissions, and antibiotic use pertaining to respiratory infections with the baseline values. Evaluate and compare the quality of life to the baseline measurements.
STUDY OVERVIEW
Methods:
The study will be conducted as an open label, non-randomized trial. Patients will be assigned to AIRVO humidification if they meet all of the inclusion/exclusion criteria of the study. All of the study participants will have the AIRVO warm humidifier installed at their home as a stand alone unit or in addition to their current LTOT therapy. For the patients that are already on LTOT, the oxygen flow setting will be increased to 20-25 l/min, to the optimum flow by taking in consideration the patient's preference.
Data:
Data to be collected includes exacerbation frequency, number of exacerbation days, and time to first exacerbation, pulmonary functions test, antibiotic usage and Quality of Life assessment.
Description of AIRVO:
The AIRVO is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The AIRVO humidifier has adjustable flow setting for delivery of fully saturated breathing gases at 37°C, 100% humidity.
Flow rates on the humidifier are adjustable between 10 and 60 L/min for this specific population (general is 2 -60 L/min). AIRVO humidifier is intended to be used in combination with medical oxygen supply. When coupled to a medical oxygen supply, the regulation of oxygen concentration is ensured, allowing for treatment of COPD patients with greater oxygen flow without risking an increased accumulation of carbon dioxide. The mixed gases, atmospheric air and with medical oxygen, pass through a humidification chamber with sterile water for humidification and heating. Breathing tubes are equipped with spiral wire, this aids with heating and ensures the uniform temperature and humidity is maintained. The air is supplied to the patients at 37°C, 100% humidity. [16]
Treatment groups:
ARIVO:
All of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system.
When acceptable flow rate has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study.
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Being tested
- Airvo Humidifier
- 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
| Study group | Role | What they receive |
|---|---|---|
| Prospective Open label | Experimental | All of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system.
When acceptable flow rated has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study Receives: Device: Airvo Humidifier |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy.
The change in number of hospitalizations compared to baseline data at 12 months.
Measured: baseline, 12 months
Change in the number of courses of antibiotic therapy compared to baseline data at 12 months
Measured: baseline, 12 months
Change in the number of courses of corticosteroid therapy compared to baseline data at 12 months.
Measured: baseline, 12 months
Change in the number of COPD medication therapy changes compared to baseline at 12 months.
Measured: baseline, 12 months
Secondary outcomes (3)
Change in Spirometry measured pulmonary function between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.
Change in Spirometry measured Pulmonary function test ( FEV1 and FEV1/FVC Forced vital capacity 1 (FEV1)- Volume forced expiration at 1.0, second in liters Forced Vital capacity - (FVC) Total amount of air in liters measured during a forced expiratory breath and peak expiratory flow) compared to baseline at 12 months
Measured: baseline, 12 months
The change in distance walked during a 6 minute walk test between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.
Change in 6 minute walk test (the distance walked in feet over a 6 minute period) compared to baseline at 12 months
Measured: baseline, 12 months
The change in the quality of life scores as measured by the Ferrans and Powers quality of life Index Pulmonary version III between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.
The change in the QOL measurements, (Ferrans and Powers Quality of Life Index Pulmonary Version -III, A two part 1 through 6 scaled survey, 1 very dissatisfied \& 6 Very satisfied. The first part focuses on how satisfied you are with the area of your life and the second on how important that area of your life is to you. Each section is comprised of 36 questions.) compared to baseline at 12 months
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2017
- Study start16 Aug 2016
- Primary completion16 Aug 2017 (estimated)
- Study completion1 Dec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be conducted as an open label, non-randomized trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lutheran Hospital, Indiana
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Eustice Fernandes MD, Lutheran Hospital, Indiana
- Investigators
- Eustace Fernandes, MD, Principal investigator, Lutheran hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03081650
- Sponsor's protocol ID
- 16-454
- Status last verified
- Feb 2017
- First submitted
- 22 Feb 2017
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ringbaek TJ, Viskum K, Lange P. Does long-term oxygen therapy reduce hospitalisation in hypoxaemic chronic obstructive pulmonary disease? Eur Respir J. 2002 Jul;20(1):38-42. doi: 10.1183/09031936.02.00284202.
PubMed 12166578Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.
PubMed 6776858Golar SD, Sutherland LL, Ford GT. Multipatient use of prefilled disposable oxygen humidifiers for up to 30 days: patient safety and cost analysis. Respir Care. 1993 Apr;38(4):343-7.
PubMed 10145893Yamashita K, Nishiyama T, Yokoyama T, Abe H, Manabe M. A comparison of the rate of bacterial contamination for prefilled disposable and reusable oxygen humidifiers. J Crit Care. 2005 Jun;20(2):172-5; discussion 175. doi: 10.1016/j.jcrc.2005.01.002.
PubMed 16139158Loew DA, Klein SR, Chalon J. Volume-controlled relative humidity using a constant-temperature water vaporizer. Anesthesiology. 1972 Feb;36(2):181-4. doi: 10.1097/00000542-197202000-00024. No abstract available.
PubMed 5059111Salah B, Dinh Xuan AT, Fouilladieu JL, Lockhart A, Regnard J. Nasal mucociliary transport in healthy subjects is slower when breathing dry air. Eur Respir J. 1988 Oct;1(9):852-5.
PubMed 3229484Miyamoto K, Nishimura M. Nasal dryness discomfort in individuals receiving dry oxygen via nasal cannula. Respir Care. 2008 Apr;53(4):503-4. No abstract available.
PubMed 18397537Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.
PubMed 27048871Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9.
PubMed 20144858Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of Hospitalizations among Patients with COPD, 2008. 2011 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #106. Available from http://www.ncbi.nlm.nih.gov/books/NBK53969/
PubMed 21510031
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the AIRVO Warm Humidifier as an Add on to Oxygen Therapy as Well as Stand-alone Therapy in Patients With Respiratory Insufficiency
- ClinicalTrials.gov ID
- NCT03081650
- Acronym / sponsor ID
- 16-454
- Conditions
- COPD, Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Lutheran Hospital, IndianaUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 16 Aug 2016 (actual)
- Primary completion
- 16 Aug 2017 (estimated)
- Study completion
- 1 Dec 2017 (estimated)
- First posted
- 16 Mar 2017 (actual)
- 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 primary purpose of this study is to show whether at home usage of the AIRVO warm humidifier can potentially reduce the number of exacerbations in patients with significant respiratory insufficiency. Eligible participants of the study must have a diagnosis of chronic obstructive pulmonary disease (COPD) stage II-IV..
Detailed description
SPECIFIC AIMS/OBJECTIVES To determine whether the patients with chronic respiratory sufficiency can benefit from the AIRVO warm humidifier by decreasing the number of exacerbations. Furthermore, to determine the efficacy of warm humidification oxygen therapy compared to dry oxygen therapy, in short-term and long-term treatment of patients with stage II-IV COPD.
Primary Objective:
To observer and compare the exacerbation frequency between the warm humidification oxygen therapy group and dry oxygen therapy group.
Secondary Objective:
Compare the number of exacerbation days, median time to first exacerbation, hospital readmissions, and antibiotic use pertaining to respiratory infections with the baseline values. Evaluate and compare the quality of life to the baseline measurements.
STUDY OVERVIEW
Methods:
The study will be conducted as an open label, non-randomized trial. Patients will be assigned to AIRVO humidification if they meet all of the inclusion/exclusion criteria of the study. All of the study participants will have the AIRVO warm humidifier installed at their home as a stand alone unit or in addition to their current LTOT therapy. For the patients that are already on LTOT, the oxygen flow setting will be increased to 20-25 l/min, to the optimum flow by taking in consideration the patient's preference.
Data:
Data to be collected includes exacerbation frequency, number of exacerbation days, and time to first exacerbation, pulmonary functions test, antibiotic usage and Quality of Life assessment.
Description of AIRVO:
The AIRVO is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases. The AIRVO humidifier has adjustable flow setting for delivery of fully saturated breathing gases at 37°C, 100% humidity.
Flow rates on the humidifier are adjustable between 10 and 60 L/min for this specific population (general is 2 -60 L/min). AIRVO humidifier is intended to be used in combination with medical oxygen supply. When coupled to a medical oxygen supply, the regulation of oxygen concentration is ensured, allowing for treatment of COPD patients with greater oxygen flow without risking an increased accumulation of carbon dioxide. The mixed gases, atmospheric air and with medical oxygen, pass through a humidification chamber with sterile water for humidification and heating. Breathing tubes are equipped with spiral wire, this aids with heating and ensures the uniform temperature and humidity is maintained. The air is supplied to the patients at 37°C, 100% humidity. [16]
Treatment groups:
ARIVO:
All of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system.
When acceptable flow rate has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will be conducted as an open label, non-randomized trial.
| Arm | Type | Receives |
|---|---|---|
| Prospective Open label | Experimental | Device: Airvo HumidifierAll of the patients that will be Selected to participate in the study will be given an AIRVO humidifier by the study sponsor. Patients will be connected to and instructed in the use of the AIRVO. The total flow will be set at 20-25 L/min, exact flow rate will be dependent on the patient's preference. Optiflow oxygen catheter will be used to ensure against unpleasant sensation due to high flow and to avoid push back in the system. When acceptable flow rated has been established, it is recorded in the patient's folder. The patients is then instructed to use the AIRVO for a minimum eight (8) hour period, preferably at night. Using the humidifier for a longer period of time is allowed. The total number of hours the humidifier was operational will be recorded at the end of the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Have stage II-IV COPD diagnosis Understand and accept oral and written information in English Be capable of handling the AIRVO warm humidifier after instruction >18years of age
Key exclusion criteria (6 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 study 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 Humidifier | Device | Prospective Open label |
Primary outcome
The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy.
Time frame: baseline, 12 months
The change in number of hospitalizations compared to baseline data at 12 months.
Change in the number of courses of antibiotic therapy compared to baseline data at 12 months
Time frame: baseline, 12 months
Change in the number of courses of corticosteroid therapy compared to baseline data at 12 months.
Time frame: baseline, 12 months
Change in the number of COPD medication therapy changes compared to baseline at 12 months.
Time frame: baseline, 12 months
3 secondary outcomes
Change in Spirometry measured pulmonary function between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.
Time frame: baseline, 12 months
The change in distance walked during a 6 minute walk test between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.
Time frame: baseline, 12 months
The change in the quality of life scores as measured by the Ferrans and Powers quality of life Index Pulmonary version III between humidification oxygen therapy and dry oxygen therapy at baseline, and 12 months.
Time frame: baseline, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Background: PubMed 12166578Ringbaek TJ, Viskum K, Lange P. Does long-term oxygen therapy reduce hospitalisation in hypoxaemic chronic obstructive pulmonary disease? Eur Respir J. 2002 Jul;20(1):38-42. doi: 10.1183/09031936.02.00284202.
- Background: PubMed 6776858Continuous or nocturnal oxygen therapy in hypoxemic chronic obstructive lung disease: a clinical trial. Nocturnal Oxygen Therapy Trial Group. Ann Intern Med. 1980 Sep;93(3):391-8. doi: 10.7326/0003-4819-93-3-391.
- Background: PubMed 10145893Golar SD, Sutherland LL, Ford GT. Multipatient use of prefilled disposable oxygen humidifiers for up to 30 days: patient safety and cost analysis. Respir Care. 1993 Apr;38(4):343-7.
- Background: PubMed 16139158Yamashita K, Nishiyama T, Yokoyama T, Abe H, Manabe M. A comparison of the rate of bacterial contamination for prefilled disposable and reusable oxygen humidifiers. J Crit Care. 2005 Jun;20(2):172-5; discussion 175. doi: 10.1016/j.jcrc.2005.01.002.
- Background: PubMed 5059111Loew DA, Klein SR, Chalon J. Volume-controlled relative humidity using a constant-temperature water vaporizer. Anesthesiology. 1972 Feb;36(2):181-4. doi: 10.1097/00000542-197202000-00024. No abstract available.
- Background: PubMed 3229484Salah B, Dinh Xuan AT, Fouilladieu JL, Lockhart A, Regnard J. Nasal mucociliary transport in healthy subjects is slower when breathing dry air. Eur Respir J. 1988 Oct;1(9):852-5.
- Background: PubMed 18397537Miyamoto K, Nishimura M. Nasal dryness discomfort in individuals receiving dry oxygen via nasal cannula. Respir Care. 2008 Apr;53(4):503-4. No abstract available.
- Background: PubMed 27048871Franchini ML, Athanazio R, Amato-Lourenco LF, Carreirao-Neto W, Saldiva PH, Lorenzi-Filho G, Rubin BK, Nakagawa NK. Oxygen With Cold Bubble Humidification Is No Better Than Dry Oxygen in Preventing Mucus Dehydration, Decreased Mucociliary Clearance, and Decline in Pulmonary Function. Chest. 2016 Aug;150(2):407-14. doi: 10.1016/j.chest.2016.03.035. Epub 2016 Apr 2.
- Background: PubMed 20144858Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9.
- Background: PubMed 21510031Wier LM, Elixhauser A, Pfuntner A, Au DH. Overview of Hospitalizations among Patients with COPD, 2008. 2011 Feb. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #106. Available from http://www.ncbi.nlm.nih.gov/books/NBK53969/
- What is COPD? National Heart Lung and Blood Institute: Diseases and Conditions Index. June 2010.Link provided by the sponsor.
- 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.
Eustace Fernandes, MD principal investigator
Lutheran hospital
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 and Chronic Obstructive Pulmonary Disease, run by Lutheran Hospital, Indiana at 1 site in United States.
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 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gordon Bokhart, Pharm D (260-435-7718, gbokhart@lhn.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in number of hospitalizations warm humidification oxygen therapy and dry oxygen therapy. (time frame: baseline, 12 months). The study lists 4 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 NCT03081650, which also lists 10 linked publications.
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 16 Mar 2017.