Chronic Obstructive Pulmonary DiseasePhase 4NCT03955770
Effects of HFOT on Exercise Performance in Patients With COPD. A Randomized, Controlled Trial.
A Phase 4 study testing High-flow oxygen therapy (HFOT) and Low-flow oxygen therapy (LFOT) in people with Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Kyrgyzstan.
Trial summary
This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- High-flow oxygen therapy (HFOT) and Low-flow oxygen therapy (LFOT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteKyrgyzstan
- Study dates
- 20 May 2019to 2 Aug 2019
- Phase
- Phase 4
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women, 35 to 75 years of age, with moderate to severe COPD, (FEV1/FVC <0.7, FEV1 40-80% predicted, resting SpO2 ≥92%, PaCO2 <6 kPa at 760 m) who live <800 m will be invited.
Who cannot join
- COPD exacerbation, very severe COPD with hypoxemia (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92%), current heavy smoking (>20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.
Trial locations and contacts
1 site in 1 country.
Kyrgyzstan1 site
National Center of Cardiology and Internal Medicine
Bishkek
About this study
Official title: Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.
This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD).
Read the detailed description
This will be a randomized, cross-over trial evaluating the efficacy of nasal HFOT vs. LFOT on cycling endurance in patients with COPD. Each patient will perform two constant load cycling exercise tests to exhaustion using HFOT and LFOT on two consecutive days, respectively, according to randomization. The load of the cycle ergometer will be set at 75% of the individually estimated maximum work rate (Wmax). During exercise tests, LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator. HFOT will be applied by a dedicated large bore nasal cannula at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- High-flow oxygen therapy (HFOT), Low-flow oxygen therapy (LFOT)
- Keywords
- Exercise endurance, High-flow oxygen therapy, Low-flow oxygen therapy
- 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 oxygen therapy (HFOT)Combination product
HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher\&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher\&Paykel, New Zealand).
Low-flow oxygen therapy (LFOT)Combination product
LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).
| Study group | Role | What they receive |
|---|---|---|
| HFOT first then LFOT | Experimental | Not described Receives: Combination Product: High-flow oxygen therapy (HFOT); Combination Product: Low-flow oxygen therapy (LFOT) |
| LFOT first then HFOT | Experimental | Not described Receives: Combination Product: High-flow oxygen therapy (HFOT); Combination Product: Low-flow oxygen therapy (LFOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exercise endurance time in seconds
Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity.
Measured: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Secondary outcomes (5)
Dyspnea sensation
Difference in the exercise induced dyspnea sensation between HFOT vs LFOT assessed by the BORG CR10 scale ranging from 0 "no dyspnea at all" to 10 "Maximum of dyspnea" assessed at the end of exercise.
Measured: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Subjective leg fatigue sensation
Difference in the exercise induced subjective leg fatigue sensation between HFOT vs LFOT assessed by the BORG CR10 scale ranging from 0 "no leg fatigue at all" to 10 "Maximum of leg fatigue" assessed at the end of exercise.
Measured: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Arterial blood gases
Difference of parameters in the arterial blood gases, in particular pH, SaO2, PaO2 and PaCO2 between HFOT vs. LFOT at the end of exercise.
Measured: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Heart rate in bpm
Difference in the maximal heart rate assessed by ECG between HFOT vs. LFOT at the end of exercise.
Measured: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Arterial blood pressure in mmHg
Difference in the maximal blood pressure between HFOT vs. LFOT at the end of exercise.
Measured: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start20 May 2019
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Responsible party
- Sponsor
- Investigators
- Michael Furian, PhD, Principal investigator, University Hospital, ZürichKonrad E Bloch, MD, Study chair, University of ZurichTalant M Sooronbaev, MD, Study director, National Center of Cardiology and Internal Medicine, Bishkek
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955770
- Sponsor's protocol ID
- 01-8/464-15
- Status last verified
- Jan 2020
- First submitted
- 16 May 2019
- Last updated
- 6 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bitos K, Furian M, Mayer L, Schneider SR, Buenzli S, Mademilov MZ, Sheraliev UU, Marazhapov NH, Abdraeva AK, Aidaralieva SD, Muratbekova AM, Sooronbaev TM, Ulrich S, Bloch KE. Effect of High-Flow Oxygen on Exercise Performance in COPD Patients. Randomized Trial. Front Med (Lausanne). 2021 Feb 19;7:595450. doi: 10.3389/fmed.2020.595450. eCollection 2020.
PubMed 33693009
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High Flow Oxygen Therapy on Exercise Performance in Patients With Chronic Obstructive Pulmonary Disease. A Randomized, Controlled Trial.
- ClinicalTrials.gov ID
- NCT03955770
- Acronym / sponsor ID
- 01-8/464-15
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Exercise endurance, High-flow oxygen therapy, Low-flow oxygen therapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Study start
- 20 May 2019 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 20 May 2019 (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.
This will be a randomized, cross-over trial evaluating the efficacy of nasal high-flow oxygen therapy (HFOT) vs. low-flow oxygen therapy (LFOT) on cycling endurance in patients with chronic obstructive pulmonary disease (COPD).
Detailed description
This will be a randomized, cross-over trial evaluating the efficacy of nasal HFOT vs. LFOT on cycling endurance in patients with COPD. Each patient will perform two constant load cycling exercise tests to exhaustion using HFOT and LFOT on two consecutive days, respectively, according to randomization. The load of the cycle ergometer will be set at 75% of the individually estimated maximum work rate (Wmax). During exercise tests, LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator. HFOT will be applied by a dedicated large bore nasal cannula at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFOT first then LFOT | Experimental | Combination Product: High-flow oxygen therapy (HFOT), Combination Product: Low-flow oxygen therapy (LFOT) |
| LFOT first then HFOT | Experimental | Combination Product: High-flow oxygen therapy (HFOT), Combination Product: Low-flow oxygen therapy (LFOT) |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men and women, 35 to 75 years of age, with moderate to severe COPD, (FEV1/FVC <0.7, FEV1 40-80% predicted, resting SpO2 ≥92%, PaCO2 <6 kPa at 760 m) who live <800 m will be invited.
Key exclusion criteria (1 listed)
- COPD exacerbation, very severe COPD with hypoxemia (FEV1/FVC <0.7, FEV1 <40% predicted, oxygen saturation on room air <92%), current heavy smoking (>20 cigarettes per day), comorbidities such as uncontrolled cardiovascular disease, internal, neurologic, rheumatologic or psychiatric disease that interfere with protocol compliance.
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 oxygen therapy (HFOT)HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher\&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher\&Paykel, New Zealand). | Combination product | HFOT first then LFOT, LFOT first then HFOT |
| Low-flow oxygen therapy (LFOT)LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics). | Combination product | HFOT first then LFOT, LFOT first then HFOT |
Primary outcome
Exercise endurance time in seconds
Time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Difference in the exercise endurance time between HFOT vs. LFOT during a constant load exercise test at 75% of the maximal work capacity.
5 secondary outcomes
Dyspnea sensation
Time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Subjective leg fatigue sensation
Time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Arterial blood gases
Time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Heart rate in bpm
Time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Arterial blood pressure in mmHg
Time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2020.
- Derived from this study: PubMed 33693009Bitos K, Furian M, Mayer L, Schneider SR, Buenzli S, Mademilov MZ, Sheraliev UU, Marazhapov NH, Abdraeva AK, Aidaralieva SD, Muratbekova AM, Sooronbaev TM, Ulrich S, Bloch KE. Effect of High-Flow Oxygen on Exercise Performance in COPD Patients. Randomized Trial. Front Med (Lausanne). 2021 Feb 19;7:595450. doi: 10.3389/fmed.2020.595450. eCollection 2020.
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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.
Michael Furian, PhD principal investigator
University Hospital, Zürich
Konrad E Bloch, MD study chair
University of Zurich
Talant M Sooronbaev, MD study director
National Center of Cardiology and Internal Medicine, Bishkek
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing High-flow oxygen therapy (HFOT) and Low-flow oxygen therapy (LFOT) in people with Chronic Obstructive Pulmonary Disease, run by University of Zurich at 1 site in Kyrgyzstan.
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 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2020. 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 Kyrgyzstan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise endurance time in seconds (time frame: HFOT on day 1 vs. LFOT on day 2 or vice versa, according to randomization). 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 NCT03955770, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2020.