Chronic Obstructive Pulmonary DiseaseNCT04217746
Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
A study testing High Flow Nasal Cannula in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by Tufts Medical Center at 1 site in United States.
Trial summary
Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD Exacerbation, Airflow Obstruction
- What is being tested?
- High Flow Nasal Cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2020to 1 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging.
- Hospital admission for acute exacerbation of COPD defined by 2018 GOLD report as acute worsening of respiratory symptoms (more than baseline cough, sputum purulence or volume, dyspnea or wheeze) that result in additional therapy.
- Presence of one or more of following: increase in sputum production, change in sputum color or difficulty in expectorating sputum.
Who cannot join
- Inability to obtain informed consent from the patient or legally authorized representative.
- Inability of the subject to cooperate with protocol.
- Presence of idiopathic bronchiectasis or cystic fibrosis.
- Patients with poor short term prognosis not expected to survive the hospitalization.
- Massive hemoptysis.
- Patients presenting with coma (Glasgow coma scale <10) or circulatory shock.
Show all 11Show fewer
- Respiratory failure requiring non-invasive ventilation (NIV) or endotracheal intubation.
- Severely impaired cough, impaired swallowing or chronic aspiration due to neuromuscular disorder.
- Facial deformity or injury leading to difficulty in wearing high flow nasal cannula appropriately.
- Enrollment in other investigative protocols with apparent overlap.
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. In an acute exacerbation setting high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients.
The purpose of the study is to determine the effects of HFNC on sputum clearance in acute exacerbation of COPD. Primary objective of the study is to determine whether HFNC improves clearability and wettability of sputum produced during acute exacerbation of COPD. Secondary objectives of the study include subjective assessment of cough severity as well as need for escalation of care after HFNC use versus conventional flow nasal oxygen (CFNO) use.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the 4th leading cause of mortality in the world. Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. During an exacerbation, high flow nasal cannula (HFNC) has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients.
Patients with a diagnosis of acute exacerbation of COPD who are receiving oxygen therapy via conventional nasal cannula or are on room air will be randomized into high flow nasal cannula (HFNC) or conventional flow nasal oxygen (CFNO) group for 24 hours. HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. CFNO group will receive ambient temperate and non-humidified oxygenated gas delivered at flow of up to 8L/min (standard care). Sputum sample will be collected at time = 0 hours (baseline), 4 +/- 1 hours, 8 +/- 2 hours and 24 +/- 2 hours. Visual analogue score (VAS) regarding cough severity and Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 and 24 hours.
Primary outcomes of the study are the difference in clearability and wettability of sputum sample. Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability. Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability. Secondary outcomes include subjective assessment of cough using VAS and BCSS scales, as well as need for escalation of care.
- Being tested
- High Flow Nasal Cannula
- Keywords
- high flow nasal cannula, sputum, clearability, wetability, chronic obstructive pulmonary disease, COPD exacerbation
- 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.
High Flow Nasal CannulaDevice
Also called Fisher and Paykel AIRVO humidified high flow system
The HFNC group will receive heated and humidified oxygenated gas delivered at high flow.
| Study group | Role | What they receive |
|---|---|---|
| High flow nasal cannula (HFNC) group | Experimental | The HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. Flow could be decreased to as low as 30L/min and temperature to 31 ⁰C as per patient's tolerance. Receives: Device: High Flow Nasal Cannula |
| Conventional flow nasal oxygen (CFNO) group | No intervention | The conventional flow nasal oxygen (CFNO) group is the control group which will receive ambient temperature and non-humidified oxygen delivered at flow rates of up to 8L/min (standard care). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clearability of sputum sample at baseline
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Measured: Sputum sample will be collected at time = 0 hours (baseline)
Clearability of sputum sample at 6 hours
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Measured: Sputum sample will be collected at time = 6 +/- 2 hours
Clearability of sputum sample at 24 hours
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Measured: Sputum sample will be collected at time = 24 +/- 2 hours
Wettability of sputum sample at baseline
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Measured: Sputum sample will be collected at time = 0 hours (baseline)
Wettability of sputum sample at 6 hours
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Measured: Sputum sample will be collected at time = 6 +/-2 hours
Wettability of sputum sample at 24 hours
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Measured: Sputum sample will be collected at time = 24 +/-2 hours
Secondary outcomes (3)
Change in cough severity
Subjective assessment of change in cough severity using a 0mm to 100mm visual analogue scale (VAS) with 0mm being no cough to 100mm being worse cough ever.
Measured: Visual analogue score regarding cough severity will be obtained at time = 0 hours (baseline), and time = 24 hours.
Change in cough frequency and easiness
Subjective assessment of cough frequency and easiness using Breathlessness, Cough and Sputum Scale (BCSS) with score ranging from 0 to 12, 0 being no cough, no difficulty breathing and no trouble due to sputum and 12 being severe difficulty breathing, constant cough and constant trouble due to sputum.
Measured: Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 hours (baseline), and time = 24 hours.
Number of participants with need for escalation of care
Need for escalation of care including non-invasive ventilation (NIV), endotracheal intubation or transfer to higher level of care.
Measured: Need for escalation will be documented at any time throughout subject's participation which is upto 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start1 Feb 2020
- Primary completion1 Feb 2025
- Study completion1 Feb 2025
Why it stopped: The pandemic interefered with the progresion of study activity.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Commonwealth University
- Responsible party
- Sponsor
- Investigators
- Nicholas Hill, MD, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217746
- Sponsor's protocol ID
- IRB#13356
- Status last verified
- Jul 2025
- First submitted
- 16 Dec 2019
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Currently there is no plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Flow Nasal Cannula on Sputum Clearance in Acute Exacerbation of Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT04217746
- Acronym / sponsor ID
- IRB#13356
- Keywords
- high flow nasal cannula, sputum, clearability, wetability, chronic obstructive pulmonary disease, COPD exacerbation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The pandemic interefered with the progresion of study activity.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Virginia Commonwealth University
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 Feb 2025 (actual)
- First posted
- 3 Jan 2020 (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.
Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. Often patients complain of sensation of sputum (phlegm) stuck in throat, which leads to worsening cough and respiratory distress. In an acute exacerbation setting high flow nasal cannula (HFNC), which is a modality that provides humidified and warm oxygenated air at flow of upto 60L/min, has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients.
The purpose of the study is to determine the effects of HFNC on sputum clearance in acute exacerbation of COPD. Primary objective of the study is to determine whether HFNC improves clearability and wettability of sputum produced during acute exacerbation of COPD. Secondary objectives of the study include subjective assessment of cough severity as well as need for escalation of care after HFNC use versus conventional flow nasal oxygen (CFNO) use.
Detailed description
Chronic obstructive pulmonary disease (COPD) is a major cause of morbidity and the 4th leading cause of mortality in the world. Acute exacerbation of COPD usually presents with more sputum production leading to worsening airflow obstruction. During an exacerbation, high flow nasal cannula (HFNC) has shown to reduce blood carbon dioxide level and respiratory rate. However, studies investigating other effects of HFNC in this setting are lacking. To investigators' knowledge, this is the first study investigating effects of HFNC on sputum clearance in COPD patients.
Patients with a diagnosis of acute exacerbation of COPD who are receiving oxygen therapy via conventional nasal cannula or are on room air will be randomized into high flow nasal cannula (HFNC) or conventional flow nasal oxygen (CFNO) group for 24 hours. HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. CFNO group will receive ambient temperate and non-humidified oxygenated gas delivered at flow of up to 8L/min (standard care). Sputum sample will be collected at time = 0 hours (baseline), 4 +/- 1 hours, 8 +/- 2 hours and 24 +/- 2 hours. Visual analogue score (VAS) regarding cough severity and Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 and 24 hours.
Primary outcomes of the study are the difference in clearability and wettability of sputum sample. Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability. Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability. Secondary outcomes include subjective assessment of cough using VAS and BCSS scales, as well as need for escalation of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flow nasal cannula (HFNC) group | Experimental | Device: High Flow Nasal CannulaThe HFNC group will receive heated (approximately 37 ⁰C) and humidified (100% relative humidity) oxygenated gas delivered at high flow at 50L/min. Flow could be decreased to as low as 30L/min and temperature to 31 ⁰C as per patient's tolerance. |
| Conventional flow nasal oxygen (CFNO) group | No intervention | –The conventional flow nasal oxygen (CFNO) group is the control group which will receive ambient temperature and non-humidified oxygen delivered at flow rates of up to 8L/min (standard care). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- Known COPD or high probability of the disease according to treating physician based on clinical history, physical examination and chest imaging.
- Hospital admission for acute exacerbation of COPD defined by 2018 GOLD report as acute worsening of respiratory symptoms (more than baseline cough, sputum purulence or volume, dyspnea or wheeze) that result in additional therapy.
- Presence of one or more of following: increase in sputum production, change in sputum color or difficulty in expectorating sputum.
Key exclusion criteria (11 listed)
- Inability to obtain informed consent from the patient or legally authorized representative.
- Inability of the subject to cooperate with protocol.
- Presence of idiopathic bronchiectasis or cystic fibrosis.
- Patients with poor short term prognosis not expected to survive the hospitalization.
- Massive hemoptysis.
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 |
|---|---|---|
| High Flow Nasal CannulaAlso: Fisher and Paykel AIRVO humidified high flow systemThe HFNC group will receive heated and humidified oxygenated gas delivered at high flow. | Device | High flow nasal cannula (HFNC) group |
Primary outcome
Clearability of sputum sample at baseline
Time frame: Sputum sample will be collected at time = 0 hours (baseline)
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Clearability of sputum sample at 6 hours
Time frame: Sputum sample will be collected at time = 6 +/- 2 hours
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Clearability of sputum sample at 24 hours
Time frame: Sputum sample will be collected at time = 24 +/- 2 hours
Clearability is measured by the distance sputum sample travels in an artificial trachea after a simulated cough. The longer the displacement, the more the clearability.
Wettability of sputum sample at baseline
Time frame: Sputum sample will be collected at time = 0 hours (baseline)
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Wettability of sputum sample at 6 hours
Time frame: Sputum sample will be collected at time = 6 +/-2 hours
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
Wettability of sputum sample at 24 hours
Time frame: Sputum sample will be collected at time = 24 +/-2 hours
Wetability is measured by determining the contact angle the sputum sample makes on a glass surface. The smaller the contact angle, the more the wettability.
3 secondary outcomes
Change in cough severity
Time frame: Visual analogue score regarding cough severity will be obtained at time = 0 hours (baseline), and time = 24 hours.
Change in cough frequency and easiness
Time frame: Breathlessness, Cough and Sputum Scale (BCSS) regarding cough frequency and ease will be obtained at time = 0 hours (baseline), and time = 24 hours.
Number of participants with need for escalation of care
Time frame: Need for escalation will be documented at any time throughout subject's participation which is upto 24 hours.
Results and safety
The study was stopped early (reason given: The pandemic interefered with the progresion of study activity.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: No. Currently there is no plan to share IPD.
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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.
Nicholas Hill, MD principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Flow Nasal Cannula in people with Chronic Obstructive Pulmonary Disease and COPD Exacerbation, run by Tufts Medical Center 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 4 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Jul 2025. 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?
The study was stopped early (reason given: The pandemic interefered with the progresion of study activity.). 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?
Clearability of sputum sample at baseline (time frame: Sputum sample will be collected at time = 0 hours (baseline)). The study lists 6 primary outcomes in all. 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 22 Jul 2025.