COPD ExacerbationHigh-TeCNCT03564236
Nasal High-Flow in COPD
A study testing Nasal High Flow Therapy in people with COPD Exacerbation, run by Marieke Duiverman at 3 sites in Netherlands.
Trial summary
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD Exacerbation
- What is being tested?
- Nasal High Flow Therapy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Oct 2018to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients have to fulfil all of the following inclusion criteria:
- History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio <70), with a history of at least 10 pack years smoking.
- Being admitted to the hospital with a COPD exacerbation
- Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH > 7.34
- At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission)
- Written informed consent is obtained
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- No lung function data available
- The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission
- Inability to comply with the tests
- The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands3 sites, 3 recruiting
- Recruiting
Rijnstate Hospital
Arnhem
Simone Elferink
- Recruiting
Albert Schweizer ziekenhuis
Dordrecht
Christiaan Theunisse
- Recruiting
University Medical Center Groningen
Groningen, 9713 GZ
Marieke L Duiverman, MD PhD, 0031-50-3613200, m.l.duiverman@umcg.nl
About this study
Official title: Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations.
Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown.
Read more
Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT.
Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating.
Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included.
Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care.
Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.
Read the detailed description
The study will be a parallel group 2-arms non blinded multicentre 2-phase randomised controlled trial comparing the effect of nHFT on subjective recovery in COPD patients admitted to the hospital for a COPD exacerbation as compared to the standard care. First, we will define the optimal setting and gain more insight in insight in mechanisms why and how nHFT might work in a subpopulation, then continuing with inclusion in the randomized controlled trial including the 136 patients in total to prove efficacy in terms of patient-centered outcomes. To get more insight in mechanisms why and how nHFT might work we incorporate: a) neuromechanical investigations and analyses; and b) anatomical investigations, both in patients and in experimental models, the latter in order to minimise patient effort.
- Conditions
- COPD Exacerbation
- Being tested
- Nasal High Flow Therapy, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High Flow TherapyDevice
Nasal High Flow Therapy (nHFT) is an innovative therapy for patients with respiratory diseases. It supplies heated, humidified, and oxygen-enriched air at high flow rates through a nasal cannula. Because the air is provided through an open system with a nasal cannula, it is relatively easy to apply and suggested to be very comfortable for patients. The technique has been shown to be effective in the treatment of hypoxemic respiratory failure, mainly in neonates[2] and patients with acute hypoxemic respiratory failure on intensive care units (ICU).[3]
Standard careOther
Standard regular care of a COPD exacerbation
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | Active comparator | Standard care is provided according to our local COPD exacerbation protocol. All patients are treated with:
* oral prednisolone 40 mg/day for 5 days;
* antibiotics prescribed according to the following criteria: fever (body temperature > 38.5 degrees Celsius), elevated C-reactive protein (CRP) >50, change in sputum colour, and/or according to the physician's decision of severe illness, and/or in all patients with a FEV1 <30% of predicted;
* high dose inhaled corticosteroids, beta-agonists and or anticholinergics.
* Oxygen will be prescribed in all patients through a standard low flow system in order to maintain an adequate arterial oxygen saturation (Sa,O2) Patients will be discharged with regular low flow oxygen once they fulfil the criteria for long-term oxygen therapy. Receives: Other: Standard care |
| Nasal High Flow Therapy | Experimental | In addition to the standard care described above, patients in the intervention group will be treated with:
* nHFT, set at 30-50 L/min flow with oxygen to achieve an adequate oxygen saturation. nHFT is prescribed for at least 6 hours, but patients are stimulated to use the device as much as possible during the hospital stay.
* During periods without HFT through a standard low flow system, to maintain an adequate arterial oxygen saturation (Sa,O2) (between 90-92% if patients are concomitantly hypercapnic, and between 90-95% if patients are normocapnic). Flow rates are titrated accordingly.
* After discharge patients in the nHFT arm will continue the prescribed therapy at home for 90 subsequent days. Receives: Device: Nasal High Flow Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-Related Quality of Life
The primary outcome will be improvement in HRQoL, defined as the net response rate on the St. George Respiratory questionnaire (SGRQ) after 90 days
Measured: 90 days
Secondary outcomes (12)
Treatment failure
Treatment failure of nHFT, defined as death, need for intensive care admission for respiratory failure, need for (non)-invasive mechanical ventilation, during the study period, in patients randomised to nHFT.
Measured: 90 days, follow-up up to 1 year
Hospitalisations
Hospital length of stay of the index admission, readmissions, readmission characteristics and complications.
Measured: 90 days, follow-up up to 1 year
Exacerbation frequency
Exacerbations will be defined as periods of symptom worsening treated with oral prednisolone and/or antibiotics.
Measured: 90 days, follow-up up to 1 year
Severe Respiratory Insufficiency Questionnaire (SRI)
Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the Severe Respiratory Insufficiency Questionnaire (SRI). This is a well-known and validated Health-Related quality of Life (HRQoL) questionnaire especially designed for patients with chronic hypercapnic respiratory failure containing 49 items measuring 7 conceptual domains of HRQoL: respiratory complaints, physical functioning, attendant symptoms and sleep, social relationships, anxiety, psychological well-being and social functioning, and a summary score. The domain scores are calculated by transforming the mean item score into a percentage ranging from 0 (most severely depressed health status as complaints/limitations are severe) to 100 (perfect health status with no complaints/limitations).
Measured: 90 days
Clinical COPD Questionnaire (CCQ)
Subjective recovery during hospitalisation and thereafter will be also investigated by assessing the Clinical COPD Questionnaire (CCQ). The CCQ is a disease specific but not "respiratory failure" specific questionnaire. It is a 10-item, self-administered questionnaire that can be completed in less than 2 minutes, and as so, is an attractive measure to be performed repeatedly during an exacerbation. Items are divided into three domains: symptom, functional state and mental state; patients are required to respond to each item on a seven-point Likert scale where 0 = asymptomatic/no limitation and 6 = extremely symptomatic/total limitation. The final score is the mean of all ten items, and scores for the three domains can be calculated separately if required.
Measured: 90 days
Euroqual-5 Dimensions questionnaire (EQ-5D)
Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the EQ-5D. The EQ-5D questionnaire is made up for two components; health state description and evaluation. In description part, health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension using five-level (EQ-5D-5L) scale.
In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS), ranging from 0 to 100.
EQ-5D-5L health states, defined by the EQ-5D-5L descriptive system, will be converted in index values, facilitating the calculation of quality-adjusted life years (QALYs) that are used to inform economic evaluations of health care interventions, according to the guideline (https://euroqol.org).
Measured: 90 days
Cough and Sputum Assessment Questionnaire (CASA-Q)
Subjective recovery during hospitalisation and thereafter will also be investigated by assessing the Cough and Sputum Assessment Questionnaire (CASA-Q). CASA-Q score is a tool for evaluating cough and sputum and their impact on patient's QOL in COPD. CASA-Q consists of two cough domains; the cough symptom domain (COUS, 11 items) and the cough impact domain (COUI, 8 items), and two sputum domains; the sputum symptom domain (SPUS, 3 items) and the sputum impact domain (SPUI, 16 items). All items will be scored from 0 to 4, such that the score was 0-12 for COUS and SPUS, and 0 to 24 for SPUI, and 0 to 32 for COUI, and each item summed and rescaled using the following algorithm: (sum rescored items)/(range of rescored item sum) x 100 (%). This results in CASA-Q scores that range from 0 to 100, with higher score associated with fewer symptoms and less impact due to cough and sputum.
Measured: 90 days
Gas exchange
Gas exchange will be monitored with both arterial blood gases during spontaneous breathing at daytime and nocturnal transcutaneous monitoring while on the prescribed therapy.
Measured: 90 days
Functional capacity
Functional capacity will be assessed at discharge and 90 days thereafter (T1 and T3) by means of calculating daily activity level, measured with a step counter
Measured: discharge and after 90 days
Assessment of cardiac function
An electrocardiogram (ECG) and blood pressure measurements will be performed. The N-terminal of the brain natriuretic peptide (NTproBNP) will be assessed by routine laboratory methods.
Measured: 90 days
Compliance
Compliance with the nHFT device will be read out from the compliance logs stored in the device when patients visit the outpatient clinic.
Measured: 90 days
Cost-effectiveness
Cost-effectiveness will be investigated by estimating the healthcare costs of nHFT and usual care and the HRQoL gains of usual care and nHFT.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2018
- Study start1 Oct 2018
- Primary completion31 Oct 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Paralell-group randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marieke Duiverman
- Sponsor type
- University, hospital or other
- Collaborators
- Rijnstate Hospital, Medisch Spectrum Twente, Albert Schweitzer Hospital, Technical University of Twente, Fisher and Paykel Healthcare, Vivisol
- Responsible party
- Sponsor-investigator, Marieke Duiverman, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03564236
- Sponsor's protocol ID
- 201800398
- Acronym
- High-TeC
- Status last verified
- Dec 2024
- First submitted
- 23 May 2018
- Last updated
- 5 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal High-Flow Therapy to Treat COPD Exacerbations: a Matter of Monitoring and Controlling Settings?
- ClinicalTrials.gov ID
- NCT03564236
- Acronym / sponsor ID
- High-TeC / 201800398
- Conditions
- COPD Exacerbation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Marieke DuivermanUniversity, hospital or other
- Collaborators
- Rijnstate Hospital, Medisch Spectrum Twente, Albert Schweitzer Hospital, Technical University of Twente, Fisher and Paykel Healthcare, Vivisol
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Jun 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.
Rationale: Chronic Obstructive Pulmonary Disease (COPD) is a disease with high morbidity and mortality worldwide. COPD exacerbations are the important contributor to disease deterioration and decrease in health-related quality of life (HRQoL). Since therapeutic options to treat exacerbations effectively are limited, many patients have persistent loss of vital functioning and suffer from frequent re-hospitalisations.
Nasal high flow therapy (nHFT) is an innovative therapy that provides humidified and heated air through a nasal cannula. Although there is some preliminary evidence that nHFT is effective in stable COPD patients, there are no data at all regarding the effectiveness of nHFT in COPD exacerbations. A key problem in the implementation of nHFT is that the underlying working mechanisms are not clear and therefore the appropriate way to apply nHFT is unknown.
Objective: The aim of the present study is to prove efficacy of nHFT in enhancing recovery from COPD exacerbations. We aim to improve the effectiveness of nHFT by developing new technologies to control and monitor the effect of nHFT and by providing background for optimal settings of nHFT.
Study design: The study will be designed as a multicentre randomised controlled trial, with the University Medical Center Groningen, the "Medisch Spectrum Twente", "Albert Schweizer ziekenhuis", Rijnstate hospital, and the University of Twente, collaborating.
Study population: One hundred thirty-six patients with known COPD GOLD stage II to IV and hypoxemic respiratory failure hospitalised with a COPD exacerbation will be included.
Intervention (if applicable): Patients will be randomised to standard care or nHFT (≥ 6 hours/day) during hospitalisation and the 90 days after discharge, as added to standard care.
Main study parameters/endpoints: The primary outcome will be improvement in HRQoL after 90 days.
Detailed description
The study will be a parallel group 2-arms non blinded multicentre 2-phase randomised controlled trial comparing the effect of nHFT on subjective recovery in COPD patients admitted to the hospital for a COPD exacerbation as compared to the standard care. First, we will define the optimal setting and gain more insight in insight in mechanisms why and how nHFT might work in a subpopulation, then continuing with inclusion in the randomized controlled trial including the 136 patients in total to prove efficacy in terms of patient-centered outcomes. To get more insight in mechanisms why and how nHFT might work we incorporate: a) neuromechanical investigations and analyses; and b) anatomical investigations, both in patients and in experimental models, the latter in order to minimise patient effort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Paralell-group randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard Care | Active comparator | Other: Standard careStandard care is provided according to our local COPD exacerbation protocol. All patients are treated with: * oral prednisolone 40 mg/day for 5 days; * antibiotics prescribed according to the following criteria: fever (body temperature > 38.5 degrees Celsius), elevated C-reactive protein (CRP) >50, change in sputum colour, and/or according to the physician's decision of severe illness, and/or in all patients with a FEV1 <30% of predicted; * high dose inhaled corticosteroids, beta-agonists and or anticholinergics. * Oxygen will be prescribed in all patients through a standard low flow system in order to maintain an adequate arterial oxygen saturation (Sa,O2) Patients will be discharged with regular low flow oxygen once they fulfil the criteria for long-term oxygen therapy. |
| Nasal High Flow Therapy | Experimental | Device: Nasal High Flow TherapyIn addition to the standard care described above, patients in the intervention group will be treated with: * nHFT, set at 30-50 L/min flow with oxygen to achieve an adequate oxygen saturation. nHFT is prescribed for at least 6 hours, but patients are stimulated to use the device as much as possible during the hospital stay. * During periods without HFT through a standard low flow system, to maintain an adequate arterial oxygen saturation (Sa,O2) (between 90-92% if patients are concomitantly hypercapnic, and between 90-95% if patients are normocapnic). Flow rates are titrated accordingly. * After discharge patients in the nHFT arm will continue the prescribed therapy at home for 90 subsequent days. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- History of COPD Global Initiative of Obstructive Lung Diseases (GOLD) stage II to IV (FEV1< 80% of predicted with an FEV1/forced vital capacity (FVC) ratio <70), with a history of at least 10 pack years smoking.
- Being admitted to the hospital with a COPD exacerbation
- Signs of compensated respiratory failure (hypercapnia (partial arterial carbon dioxide pressure (PaCO2) ≥ 6.0 kPa and/or hypoxemia (partial arterial oxygen pressure (PaO2) ≤ 8.0 kPa at room air), with pH > 7.34
- At least 2 COPD exacerbations in the year prior to the index hospital admission (exacerbation defined as worsening of pulmonary symptoms requiring oral steroids and/or antibiotics and/or hospital admission)
- Written informed consent is obtained
Key exclusion criteria (5 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- No lung function data available
- The presence of another acute condition (e.g. pneumonia, acute congestive heart failure, pulmonary embolus) explaining or significantly contributing to the index admission
- Inability to comply with the tests
- The presence of another chronic lung disease (e.g. asthma, restrictive lung disease).
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 |
|---|---|---|
| Nasal High Flow TherapyNasal High Flow Therapy (nHFT) is an innovative therapy for patients with respiratory diseases. It supplies heated, humidified, and oxygen-enriched air at high flow rates through a nasal cannula. Because the air is provided through an open system with a nasal cannula, it is relatively easy to apply and suggested to be very comfortable for patients. The technique has been shown to be effective in the treatment of hypoxemic respiratory failure, mainly in neonates[2] and patients with acute hypoxemic respiratory failure on intensive care units (ICU).[3] | Device | Nasal High Flow Therapy |
| Standard careStandard regular care of a COPD exacerbation | Other | Standard Care |
Primary outcome
Health-Related Quality of Life
Time frame: 90 days
The primary outcome will be improvement in HRQoL, defined as the net response rate on the St. George Respiratory questionnaire (SGRQ) after 90 days
12 secondary outcomes
Treatment failure
Time frame: 90 days, follow-up up to 1 year
Hospitalisations
Time frame: 90 days, follow-up up to 1 year
Exacerbation frequency
Time frame: 90 days, follow-up up to 1 year
Severe Respiratory Insufficiency Questionnaire (SRI)
Time frame: 90 days
Clinical COPD Questionnaire (CCQ)
Time frame: 90 days
Euroqual-5 Dimensions questionnaire (EQ-5D)
Time frame: 90 days
Cough and Sputum Assessment Questionnaire (CASA-Q)
Time frame: 90 days
Gas exchange
Time frame: 90 days
Functional capacity
Time frame: discharge and after 90 days
Assessment of cardiac function
Time frame: 90 days
Compliance
Time frame: 90 days
Cost-effectiveness
Time frame: 90 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High Flow Therapy in people with COPD Exacerbation, run by Marieke Duiverman at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 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: looking for participants now, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marieke L Duiverman, MD PhD (0031-50-3613200, m.l.duiverman@umcg.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-Related Quality of Life (time frame: 90 days). 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 5 Dec 2024.