COPD ExacerbationNCT03772626
Heated High Humidity After COPD Exacerbation
A study testing Heated Humidified High-flow Nasal Cannula in people with COPD Exacerbation, run by McMaster University at 1 site in Canada.
Trial summary
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and phlegm. COPD is one of the leading causes of disability and death in Canada. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Heated Humidified High-flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 25 Feb 2019to 1 Dec 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted to Hospital with a primary diagnosis of exacerbation of COPD
- Greater then or equal to 20 pack year history of smoking
- Participating in Integrated Comprehensive Care (ICC) home care program
Who cannot join
- Requirement for acute non-invasive ventilation in hospital
- Use of nocturnal non-invasive ventilation prior to hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility and Efficacy of Heated Humidified Nasal Cannula (AIRVOTM) in Hospital and at Home - An Open-Label, Non-Randomized Pilot Study.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with COPD often have periodic worsening of their disease, called exacerbations, consisting of increased shortness of breath and often an increase in cough and phlegm. These exacerbations often lead to hospital admission and are associated with worsening symptoms and lung function over time. After an exacerbation individuals with COPD usually take several weeks to return to their previous state of health and many people with an exacerbation who are discharged from hospital return to the ER within 60. Heated humidified air has been shown to improve the clearance of mucous in the lungs for people with chronic lung disease. By providing patients at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for delivering heated high humidity air to use overnight it is hoped that these individuals will be able to more easily keep their lungs and airways free of mucous. This in turn may lead to improvement in their symptoms of shortness of breath, cough, and phlegm production as well as decreasing obstruction of the airways to reduce the risk of having to return to the emergency room or hospital.
Read the detailed description
COPD is a respiratory condition that is often associated with cigarette smoking, and defined by incompletely reversible airflow obstruction and complicated by exacerbations. Mucous hypersecretion with impaired mucociliary transport are frequently present, and are associated with infective AECOPD, and death related to pulmonary infection. COPD is both common, affecting 1 in 6 Canadians, and burdensome, being the 4th leading cause of death, in the Canadian population.
In Canada, the most common primary diagnosis associated with admission to hospital is acute exacerbation of COPD (AECOPD). For moderate to severe COPD, the average patient will have more than 2 AECOPD per year. A single episode conveys a poor prognosis, being associated with death, further AECOPD events, and reduced health-related quality of life. Despite multiple guideline-based management strategies, 1 in 3 patients with AECOPD will have another episode within 8 weeks.
Although the technology for heated humidified high-flow nasal cannula (HFNC) has been available for two decades, it has only recently become widely available for adults. The rapid humidification of gas allows this system to achieve flow rates of up to 60 liters per minute. These two factors, in combination, allow for a higher achieved fraction of inspired oxygen, and benefit the expectoration of secretions and ventilatory efficiency. Randomised clinical trials of ICU patients have demonstrated that HFNC is non-inferior to non-invasive ventilation both in the setting of acute hypoxemic respiratory failure and as an adjunct therapy post-extubation.
HFNC is a promising treatment for patients with COPD as it can counteract potentially harmful mucous abnormalities by reducing mucous viscosity and restoring mucociliary transport. Randomised studies have also demonstrated that HFNC administered at home results in an increased the time to first exacerbation, fewer AECOPD, improved quality-of-life, and reduced PaCO2. However, the efficacy of HFNC during hospital admission, when mucous abnormalities and poor expectoration could be most pronounced, has not yet been studied. Furthermore, the feasibility and efficacy of this device as a patient transitions from the hospital to the community after an AECOPD remains to be elucidated.
The objectives of this study are to test the efficacy of a heated humidified high-flow nasal cannula used during and after a hospital admission for AECOPD to reduce the risk of return to ER or readmission, and the feasibility of implementing such a device starting in hospital with transition to the home environment.
This is an open-label, non-randomized pilot study of in-hospital and home HFNC in patients with COPD. Patients who consent to participate will have an a heated humidified high-flow nasal cannula device configured by a respiratory therapist and available at their bedside in hospital. Fraction of inspired oxygen will be adjusted as needed to obtain a pulse oximetry reading between 88-92%. If hypoxemia is not present (peripheral oxygen saturation (SpO2) ≥88%) on room air, then the device will be used without supplemental oxygen. Temperature and flow rate will be titrated for patient comfort with a target temperature of 37 degrees Celsius and flow rate of ≥20 liters per minute if tolerated. Participants will be instructed to use the device overnight and as much as they like during the day targeting at least 6 hours of use per 24 hour period.
At discharge, subjects will be provided with a heated humidified high-flow nasal cannula home device. Targeted use and oxygen titration will remain unchanged from inpatient use. A respiratory therapist from will perform a home visit within 24 hours of hospital discharge to educate the patient on home use and ensure proper set up of the device, and an additional visit 2 weeks post-discharge. Patients will have access to a 24 hour emergency telephone number if they have any concerns. The duration of the trial will be 60 days post-discharge after which the device will be returned.
- Conditions
- COPD Exacerbation
- Being tested
- Heated Humidified High-flow Nasal Cannula
- Keywords
- COPD, Heated humidified high-flow nasal cannula, Exacerbation of COPD
- 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.
Heated Humidified High-flow Nasal CannulaDevice
Patients will receive heated high humidity air through the AIRVO(TM) device starting in hospital and continuing for 60 days after hospital discharge. Oxygen will be titrated to target SpO2 between 88-92%, patients not requiring oxygen will receive heated high humidity air without oxygen. Temperature and flow rate will titrated to patient comfort with a target temperature 37 degree Celsius and flow rate of ≥20 l/minute. Patients will be encouraged to use the device overnight and when needed during the day with a target duration of at least 6 hours per night
| Study group | Role | What they receive |
|---|---|---|
| Heated humidified high-flow | Experimental | Heated Humidified High-flow Nasal Cannula Receives: Device: Heated Humidified High-flow Nasal Cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
ER use or hospitalization for COPD
ER visits or hospital admissions for COPD during the 60 day treatment period
Measured: Length of study participation (60 days after hospital discharge)
Secondary outcomes (2)
Hospital length of stay
Total length of stay in hospital during index admission for COPD
Measured: Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days)
Use of home-care resources
Total number of unplanned home visits during study period
Measured: Length of study participation (60 days after hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start25 Feb 2019
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for COPD ExacerbationStudies 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
- Single group non-randomized open label study of efficacy and feasibility. Comparison will be to historical controls.
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Joshua Wald, McMaster University
- Investigators
- Joshua Wald, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772626
- Sponsor's protocol ID
- Heated Humidity after COPDE
- Status last verified
- Apr 2022
- First submitted
- 6 Dec 2018
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
O'Donnell DE, Aaron S, Bourbeau J, Hernandez P, Marciniuk DD, Balter M, Ford G, Gervais A, Goldstein R, Hodder R, Kaplan A, Keenan S, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2007 update. Can Respir J. 2007 Sep;14 Suppl B(Suppl B):5B-32B. doi: 10.1155/2007/830570.
PubMed 17885691Rogers DF. The role of airway secretions in COPD: pathophysiology, epidemiology and pharmacotherapeutic options. COPD. 2005 Sep;2(3):341-53. doi: 10.1080/15412550500218098.
PubMed 17146999Prescott E, Lange P, Vestbo J. Chronic mucus hypersecretion in COPD and death from pulmonary infection. Eur Respir J. 1995 Aug;8(8):1333-8. doi: 10.1183/09031936.95.08081333.
PubMed 7489800Gershon AS, Thiruchelvam D, Chapman KR, Aaron SD, Stanbrook MB, Bourbeau J, Tan W, To T; Canadian Respiratory Research Network. Health Services Burden of Undiagnosed and Overdiagnosed COPD. Chest. 2018 Jun;153(6):1336-1346. doi: 10.1016/j.chest.2018.01.038. Epub 2018 Feb 6.
PubMed 29425675O'Donnell DE, Hernandez P, Kaplan A, Aaron S, Bourbeau J, Marciniuk D, Balter M, Ford G, Gervais A, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care. Can Respir J. 2008 Jan-Feb;15 Suppl A(Suppl A):1A-8A. doi: 10.1155/2008/641965.
PubMed 18292855Keene JD, Jacobson S, Kechris K, Kinney GL, Foreman MG, Doerschuk CM, Make BJ, Curtis JL, Rennard SI, Barr RG, Bleecker ER, Kanner RE, Kleerup EC, Hansel NN, Woodruff PG, Han MK, Paine R 3rd, Martinez FJ, Bowler RP, O'Neal WK; COPDGene and SPIROMICS Investigators double dagger. Biomarkers Predictive of Exacerbations in the SPIROMICS and COPDGene Cohorts. Am J Respir Crit Care Med. 2017 Feb 15;195(4):473-481. doi: 10.1164/rccm.201607-1330OC.
PubMed 27579823Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592.
PubMed 8887592Groenewegen KH, Schols AM, Wouters EF. Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest. 2003 Aug;124(2):459-67. doi: 10.1378/chest.124.2.459.
PubMed 12907529Pradan L, Ferreira I, Postolache P. The quality of medical care during an acute exacerbations of chronic obstructive pulmonary disease. Rev Med Chir Soc Med Nat Iasi. 2013 Oct-Dec;117(4):870-4.
PubMed 24502063Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.
PubMed 16443707Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
PubMed 25742321Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
PubMed 25981908Hernandez G, Vaquero C, Colinas L, Cuena R, Gonzalez P, Canabal A, Sanchez S, Rodriguez ML, Villasclaras A, Fernandez R. Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in High-Risk Patients: A Randomized Clinical Trial. JAMA. 2016 Oct 18;316(15):1565-1574. doi: 10.1001/jama.2016.14194.
PubMed 27706464Rea 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 20144858Storgaard LH, Hockey HU, Laursen BS, Weinreich UM. Long-term effects of oxygen-enriched high-flow nasal cannula treatment in COPD patients with chronic hypoxemic respiratory failure. Int J Chron Obstruct Pulmon Dis. 2018 Apr 16;13:1195-1205. doi: 10.2147/COPD.S159666. eCollection 2018.
PubMed 29713153
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility and Efficacy of Heated Humidified Nasal Cannula (AIRVOTM) in Hospital and at Home - An Open-Label, Non-Randomized Pilot Study.
- ClinicalTrials.gov ID
- NCT03772626
- Acronym / sponsor ID
- Heated Humidity after COPDE
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Heated humidified high-flow nasal cannula, Exacerbation of COPD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- 25 Feb 2019 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 11 Dec 2018 (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.
Chronic obstructive pulmonary disease (COPD) is a chronic lung disease usually caused by exposure to tobacco smoke which leads to chronic symptoms of shortness of breath, cough, and phlegm. COPD is one of the leading causes of disability and death in Canada. Individuals with COPD often have periodic worsening of their disease, called exacerbations, consisting of increased shortness of breath and often an increase in cough and phlegm. These exacerbations often lead to hospital admission and are associated with worsening symptoms and lung function over time. After an exacerbation individuals with COPD usually take several weeks to return to their previous state of health and many people with an exacerbation who are discharged from hospital return to the ER within 60. Heated humidified air has been shown to improve the clearance of mucous in the lungs for people with chronic lung disease. By providing patients at St. Joseph's Hospital who are discharged after a COPD exacerbation with a device for delivering heated high humidity air to use overnight it is hoped that these individuals will be able to more easily keep their lungs and airways free of mucous. This in turn may lead to improvement in their symptoms of shortness of breath, cough, and phlegm production as well as decreasing obstruction of the airways to reduce the risk of having to return to the emergency room or hospital.
Detailed description
COPD is a respiratory condition that is often associated with cigarette smoking, and defined by incompletely reversible airflow obstruction and complicated by exacerbations. Mucous hypersecretion with impaired mucociliary transport are frequently present, and are associated with infective AECOPD, and death related to pulmonary infection. COPD is both common, affecting 1 in 6 Canadians, and burdensome, being the 4th leading cause of death, in the Canadian population.
In Canada, the most common primary diagnosis associated with admission to hospital is acute exacerbation of COPD (AECOPD). For moderate to severe COPD, the average patient will have more than 2 AECOPD per year. A single episode conveys a poor prognosis, being associated with death, further AECOPD events, and reduced health-related quality of life. Despite multiple guideline-based management strategies, 1 in 3 patients with AECOPD will have another episode within 8 weeks.
Although the technology for heated humidified high-flow nasal cannula (HFNC) has been available for two decades, it has only recently become widely available for adults. The rapid humidification of gas allows this system to achieve flow rates of up to 60 liters per minute. These two factors, in combination, allow for a higher achieved fraction of inspired oxygen, and benefit the expectoration of secretions and ventilatory efficiency. Randomised clinical trials of ICU patients have demonstrated that HFNC is non-inferior to non-invasive ventilation both in the setting of acute hypoxemic respiratory failure and as an adjunct therapy post-extubation.
HFNC is a promising treatment for patients with COPD as it can counteract potentially harmful mucous abnormalities by reducing mucous viscosity and restoring mucociliary transport. Randomised studies have also demonstrated that HFNC administered at home results in an increased the time to first exacerbation, fewer AECOPD, improved quality-of-life, and reduced PaCO2. However, the efficacy of HFNC during hospital admission, when mucous abnormalities and poor expectoration could be most pronounced, has not yet been studied. Furthermore, the feasibility and efficacy of this device as a patient transitions from the hospital to the community after an AECOPD remains to be elucidated.
The objectives of this study are to test the efficacy of a heated humidified high-flow nasal cannula used during and after a hospital admission for AECOPD to reduce the risk of return to ER or readmission, and the feasibility of implementing such a device starting in hospital with transition to the home environment.
This is an open-label, non-randomized pilot study of in-hospital and home HFNC in patients with COPD. Patients who consent to participate will have an a heated humidified high-flow nasal cannula device configured by a respiratory therapist and available at their bedside in hospital. Fraction of inspired oxygen will be adjusted as needed to obtain a pulse oximetry reading between 88-92%. If hypoxemia is not present (peripheral oxygen saturation (SpO2) ≥88%) on room air, then the device will be used without supplemental oxygen. Temperature and flow rate will be titrated for patient comfort with a target temperature of 37 degrees Celsius and flow rate of ≥20 liters per minute if tolerated. Participants will be instructed to use the device overnight and as much as they like during the day targeting at least 6 hours of use per 24 hour period.
At discharge, subjects will be provided with a heated humidified high-flow nasal cannula home device. Targeted use and oxygen titration will remain unchanged from inpatient use. A respiratory therapist from will perform a home visit within 24 hours of hospital discharge to educate the patient on home use and ensure proper set up of the device, and an additional visit 2 weeks post-discharge. Patients will have access to a 24 hour emergency telephone number if they have any concerns. The duration of the trial will be 60 days post-discharge after which the device will be returned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group non-randomized open label study of efficacy and feasibility. Comparison will be to historical controls.
| Arm | Type | Receives |
|---|---|---|
| Heated humidified high-flow | Experimental | Device: Heated Humidified High-flow Nasal CannulaHeated Humidified High-flow Nasal Cannula |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admitted to Hospital with a primary diagnosis of exacerbation of COPD
- Greater then or equal to 20 pack year history of smoking
- Participating in Integrated Comprehensive Care (ICC) home care program
Key exclusion criteria (2 listed)
- Requirement for acute non-invasive ventilation in hospital
- Use of nocturnal non-invasive ventilation prior to hospitalization
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 |
|---|---|---|
| Heated Humidified High-flow Nasal CannulaPatients will receive heated high humidity air through the AIRVO(TM) device starting in hospital and continuing for 60 days after hospital discharge. Oxygen will be titrated to target SpO2 between 88-92%, patients not requiring oxygen will receive heated high humidity air without oxygen. Temperature and flow rate will titrated to patient comfort with a target temperature 37 degree Celsius and flow rate of ≥20 l/minute. Patients will be encouraged to use the device overnight and when needed during the day with a target duration of at least 6 hours per night | Device | Heated humidified high-flow |
Primary outcome
ER use or hospitalization for COPD
Time frame: Length of study participation (60 days after hospital discharge)
ER visits or hospital admissions for COPD during the 60 day treatment period
2 secondary outcomes
Hospital length of stay
Time frame: Collected throughout inpatient enrollment period until last enrolled patient discharged (Expected total of 70 days)
Use of home-care resources
Time frame: Length of study participation (60 days after hospital discharge)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Background: PubMed 17885691O'Donnell DE, Aaron S, Bourbeau J, Hernandez P, Marciniuk DD, Balter M, Ford G, Gervais A, Goldstein R, Hodder R, Kaplan A, Keenan S, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2007 update. Can Respir J. 2007 Sep;14 Suppl B(Suppl B):5B-32B. doi: 10.1155/2007/830570.
- Background: PubMed 17146999Rogers DF. The role of airway secretions in COPD: pathophysiology, epidemiology and pharmacotherapeutic options. COPD. 2005 Sep;2(3):341-53. doi: 10.1080/15412550500218098.
- Background: PubMed 7489800Prescott E, Lange P, Vestbo J. Chronic mucus hypersecretion in COPD and death from pulmonary infection. Eur Respir J. 1995 Aug;8(8):1333-8. doi: 10.1183/09031936.95.08081333.
- Background: PubMed 29425675Gershon AS, Thiruchelvam D, Chapman KR, Aaron SD, Stanbrook MB, Bourbeau J, Tan W, To T; Canadian Respiratory Research Network. Health Services Burden of Undiagnosed and Overdiagnosed COPD. Chest. 2018 Jun;153(6):1336-1346. doi: 10.1016/j.chest.2018.01.038. Epub 2018 Feb 6.
- Background: PubMed 18292855O'Donnell DE, Hernandez P, Kaplan A, Aaron S, Bourbeau J, Marciniuk D, Balter M, Ford G, Gervais A, Lacasse Y, Maltais F, Road J, Rocker G, Sin D, Sinuff T, Voduc N. Canadian Thoracic Society recommendations for management of chronic obstructive pulmonary disease - 2008 update - highlights for primary care. Can Respir J. 2008 Jan-Feb;15 Suppl A(Suppl A):1A-8A. doi: 10.1155/2008/641965.
- Background: PubMed 27579823Keene JD, Jacobson S, Kechris K, Kinney GL, Foreman MG, Doerschuk CM, Make BJ, Curtis JL, Rennard SI, Barr RG, Bleecker ER, Kanner RE, Kleerup EC, Hansel NN, Woodruff PG, Han MK, Paine R 3rd, Martinez FJ, Bowler RP, O'Neal WK; COPDGene and SPIROMICS Investigators double dagger. Biomarkers Predictive of Exacerbations in the SPIROMICS and COPDGene Cohorts. Am J Respir Crit Care Med. 2017 Feb 15;195(4):473-481. doi: 10.1164/rccm.201607-1330OC.
- Background: PubMed 8887592Connors AF Jr, Dawson NV, Thomas C, Harrell FE Jr, Desbiens N, Fulkerson WJ, Kussin P, Bellamy P, Goldman L, Knaus WA. Outcomes following acute exacerbation of severe chronic obstructive lung disease. The SUPPORT investigators (Study to Understand Prognoses and Preferences for Outcomes and Risks of Treatments). Am J Respir Crit Care Med. 1996 Oct;154(4 Pt 1):959-67. doi: 10.1164/ajrccm.154.4.8887592.
- Background: PubMed 12907529Groenewegen KH, Schols AM, Wouters EF. Mortality and mortality-related factors after hospitalization for acute exacerbation of COPD. Chest. 2003 Aug;124(2):459-67. doi: 10.1378/chest.124.2.459.
- Background: PubMed 24502063Pradan L, Ferreira I, Postolache P. The quality of medical care during an acute exacerbations of chronic obstructive pulmonary disease. Rev Med Chir Soc Med Nat Iasi. 2013 Oct-Dec;117(4):870-4.
- Background: PubMed 16443707Donaldson GC, Wedzicha JA. COPD exacerbations .1: Epidemiology. Thorax. 2006 Feb;61(2):164-8. doi: 10.1136/thx.2005.041806.
- Background: PubMed 25742321Spoletini G, Alotaibi M, Blasi F, Hill NS. Heated Humidified High-Flow Nasal Oxygen in Adults: Mechanisms of Action and Clinical Implications. Chest. 2015 Jul;148(1):253-261. doi: 10.1378/chest.14-2871.
- Background: PubMed 25981908Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
- 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.
Joshua Wald, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heated Humidified High-flow Nasal Cannula in people with COPD Exacerbation, run by McMaster University at 1 site in Canada.
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 3 inclusion and 2 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 7 Apr 2022. 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 Canada. 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?
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?
ER use or hospitalization for COPD (time frame: Length of study participation (60 days after hospital discharge)). 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 NCT03772626, which also lists 15 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 7 Apr 2022.