COPDRESPHYCNCT07065799
Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation
A study testing Group 1: NHF/LTOT and Group 2: HMV/LTOT in people with COPD and Hypercapnia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 5 sites in Italy.
Trial summary
This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV), both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- COPD, Hypercapnia, Exacerbation Copd
- What is being tested?
- Group 1: NHF/LTOT and Group 2: HMV/LTOT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 5 sitesItaly
- Study dates
- 30 Jun 2024to Jan 2028
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Acquisition of informed consent form
- Patients with COPD
- Persistent hypercapnia (PaCO2 >53 mmHg) 2-4 weeks after an acute hypercapnic exacerbation of COPD requiring NIV.
- pH value >7.35.
- Chronic hypoxemia (PaO2 <55mmHg or <60mmHg if at least one of the following criteria is present: polycythemia, pulmonary hypertension or Chronic Pulmonary Heart Disease, >30% of sleep time with SpO2 < 90% measured with a pulse oximeter)
Who cannot join
- BMI >30 kg/m2
- Clinically significant obstructive sleep apnea syndrome (patients in whom there was a clinical suspicion of OSA syndrome based on clinical review or overnight oximetry will go further testing with limited respiratory polygraphy)
- Neuromuscular or chest wall diseases
- Need for intubation and invasive mechanical ventilation during exacerbation
- Use of home non-invasive mechanical ventilation or CPAP
- Contraindications for NIV
Show all 9Show fewer
- Presence of cognitive impairment that would prevent informed consent into the trial
- Patients with active and unstable coronary artery syndrome
- Patients suffering from malignancies
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Recruiting
Ospedale S Donato
Arezzo
Raffaele Scala
Raffaele Scala
- Recruiting
Bolzano Hospital
Bolzano
roberto dongilli
Roberto Dongilli
- Recruiting
Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco"
Catania
Claudia Crimi
Claudia Crimi
- Recruiting
ICS Maugeri Spa Società Benefit IRCCS
Pavia
Annalisa Carlucci
- Recruiting
Azienda Unità Sanitaria Locale
Piacenza
Cosimo Franco
Cosimo Franco
About this study
Official title: Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study
This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV), both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation.
The purpose is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV.
Read more
Partecipants will be randomized at 1:1 ratio into two groups:
group 1: will start the respiratory strategy under study (NHF + standard oxygen therapy) as first treatment group 2 will start the control respiratory strategy (HMV + standard oxygen therapy) as first treatment.
The study has a crossover design: each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months
Read the detailed description
This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV) both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation. The purpose of this study is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV.
Patients will be randomly assigned through a simple randomization list, stratified by recruiting center, generated by the Stata statistical software. Based on this list, patients will be divided into two groups: group 1 will start as the first treatment with the respiratory strategy under study (NHF + standard oxygen therapy) and group 2 will start as the first treatment with the control respiratory strategy (HMV + standard oxygen therapy). Randomization will occur at a 1:1 ratio. The study has a crossover design; each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months. To minimize the carry-over effect, a washout period of 7 days between respiratory supports will be scheduled. Therefore, considering the washout period, the total treatment duration is 25 weeks.
- Conditions
- COPD, Hypercapnia, Exacerbation Copd
- Being tested
- Group 1: NHF/LTOT, Group 2: HMV/LTOT
- Keywords
- COPD, hypercapnia, NHF, HMV, PaCO2
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypercapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1: NHF/LTOTDevice
Patients assigned to this group will start NHF (Nasal High Flow) + oxygen therapy at home and undergo a preliminary trial with NHF to set the optimal flow using the MyAIRVO 3 (Fisher \& Paykel Healthcare, Auckland, New Zealand) with Optiflow+Duet interface. Patients assigned to this group will be required to use NHF for a minimum of 6 hours per night during sleep, while no restrictions will be set on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the control respiratory strategy (HMV+LTOT) will begin.
Group 2: HMV/LTOTDevice
Patients assigned to this group will start home treatment with HMV (Home Mechanical Ventilation) + oxygen therapy and will be treated with HMV using a pressure support (PS) ventilator. HMV will be administered via nasal mask or full face mask according to patients' preference. Patients assigned to this group will be required to use HMV for a minimum of 6 hours per night in addition to daily home oxygen therapy for at least 15 hours. Moreover, no restrictions will be imposed on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the studied respiratory strategy (NHF+LTOT) will begin.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | NHF/LTOT Receives: Device: Group 1: NHF/LTOT |
| Group 2 | Active comparator | HMV/LTOT Receives: Device: Group 2: HMV/LTOT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the non-inferiority of the change in PaCO2 levels measured during treatment with NHF respiratory support compared to HMV respiratory support, both associated with standard oxygen therapy.
Unity of measurement: mmHg
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
Secondary outcomes (12)
Evaluation of the time required for setting up and adjusting the two respiratory strategies.
Unit of measurement: days
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of PaO2 levels measured via arterial blood gas analysis
Unit of measurement: mmHg
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
FVC, FEV1
Measured by spirometry Unit of measurement for FVC and FEV1: L
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of exercise capacity measured using the 6-minute walk test (6MWT)
Unit of measurement: meters
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of dyspnea measured using the Medical Research Council Dyspnea score
mMRC score ranges from 0 to 4. 0=No dyspnea symptoms 4=severe dyspnea
Measured: aT0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of quality of life measured using the St. George's Respiratory Questionnaire
SGRQ's Total Score ranges between 0 and 100, where 0 is maximum quality of life and 100 is lowest quality of life
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of quality of sleep measured using the Pittsburg Sleep Quality Index
PSQI ranges from 0 to 21, higher score indicate worse sleep quality
Measured: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of compliance to respiratory supports measured by downloading usage data from the respiratory support.
Time of usage of the respiratory support in hours/day and hours/night.
Measured: T1 (+3months), T2 (+6months)
Evaluation of tolerance to respiratory supports meauserd using visual analog scales
Visual analog scale ranges between 0 to 10, 0=minimum tolerance 10=maximum tolerance
Measured: T1 (+3months), T2 (+6months)
Evaluation of frequency of exacerbations measured by counting the numbers of exacerbations occurred.
Unit of measurement: number of events
Measured: three, six and 12 month since the beginning of the treatment
Evaluation of severity of exacerbations and subsequent hospitalizations measured by counting the number of exacerbations that required hospitalizations
Unity of measurement: number of exacerbation that required hospitalisation
Measured: T1 (+3months), T2 (+6months) and T3 (+12months)
Evaluation of survival measured by mortality analysis
Measured: T1 (+3months), T2 (+6months) and T3 (+12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start30 Jun 2024
- Primary completionDec 2027 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicenter, randomized, controlled, crossover, non-inferiority
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Sanitaria dell'Alto Adige, Ospedale San Donato, Azienda Unita Sanitaria Locale di Piacenza, Policlinico Universitario, Catania, Fondazione Salvatore Maugeri
- Responsible party
- Principal investigator, dr. Stefano Nava, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Investigators
- Lara Pisani, Prof.ssa, Principal investigator, University of Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065799
- Sponsor's protocol ID
- n° 22/2024/Disp/AOUBo
- Acronym
- RESPHYC
- Status last verified
- Jul 2025
- First submitted
- 17 May 2024
- Last updated
- 15 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.
PubMed 28528348Ergan B, Oczkowski S, Rochwerg B, Carlucci A, Chatwin M, Clini E, Elliott M, Gonzalez-Bermejo J, Hart N, Lujan M, Nasilowski J, Nava S, Pepin JL, Pisani L, Storre JH, Wijkstra P, Tonia T, Boyd J, Scala R, Windisch W. European Respiratory Society guidelines on long-term home non-invasive ventilation for management of COPD. Eur Respir J. 2019 Sep 28;54(3):1901003. doi: 10.1183/13993003.01003-2019. Print 2019 Sep.
PubMed 31467119Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
PubMed 34649974Storgaard 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 29713153Weinreich UM, Juhl KS, Soby Christophersen M, Gundestrup S, Hanifa MA, Jensen K, Andersen FD, Hilberg O, Storgaard LH. The Danish respiratory society guideline for long-term high flow nasal cannula treatment, with or without supplementary oxygen. Eur Clin Respir J. 2023 Feb 23;10(1):2178600. doi: 10.1080/20018525.2023.2178600. eCollection 2023.
PubMed 36861118Pisani L, Vega ML. Use of Nasal High Flow in Stable COPD: Rationale and Physiology. COPD. 2017 Jun;14(3):346-350. doi: 10.1080/15412555.2017.1315715. Epub 2017 May 1.
PubMed 28459282
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation: A Multicenter, Non-inferiority, Randomized, Crossover Study
- ClinicalTrials.gov ID
- NCT07065799
- Acronym / sponsor ID
- RESPHYC / n° 22/2024/Disp/AOUBo
- Conditions
- COPD, Hypercapnia, Exacerbation Copd
- Keywords
- COPD, hypercapnia, NHF, HMV, PaCO2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Collaborators
- Azienda Sanitaria dell'Alto Adige, Ospedale San Donato, Azienda Unita Sanitaria Locale di Piacenza, Policlinico Universitario, Catania, Fondazione Salvatore Maugeri
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 15 Jul 2025 (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 multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV), both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation.
The purpose is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV.
Partecipants will be randomized at 1:1 ratio into two groups:
group 1: will start the respiratory strategy under study (NHF + standard oxygen therapy) as first treatment group 2 will start the control respiratory strategy (HMV + standard oxygen therapy) as first treatment.
The study has a crossover design: each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months
Detailed description
This multicenter, cross-over study aims to investigate the effects of two different respiratory strategies, the use of high flow nasal cannula (NHF) and the use of home mechanic ventilation (HMV) both associated with standard oxygen therapy, in patients with COPD and persistent hypercapnia following a severe acute exacerbation. The purpose of this study is to evaluate whether the clinical benefits, in terms of reduction in PaCO2 levels, resulting from the use of NHF are non-inferior to those obtained from the use of HMV.
Patients will be randomly assigned through a simple randomization list, stratified by recruiting center, generated by the Stata statistical software. Based on this list, patients will be divided into two groups: group 1 will start as the first treatment with the respiratory strategy under study (NHF + standard oxygen therapy) and group 2 will start as the first treatment with the control respiratory strategy (HMV + standard oxygen therapy). Randomization will occur at a 1:1 ratio. The study has a crossover design; each patient will undergo treatment with the two different respiratory strategies, NHF and HMV, each lasting for 3 months. To minimize the carry-over effect, a washout period of 7 days between respiratory supports will be scheduled. Therefore, considering the washout period, the total treatment duration is 25 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized, controlled, crossover, non-inferiority
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Group 1: NHF/LTOTNHF/LTOT |
| Group 2 | Active comparator | Device: Group 2: HMV/LTOTHMV/LTOT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years
- Acquisition of informed consent form
- Patients with COPD
- Persistent hypercapnia (PaCO2 >53 mmHg) 2-4 weeks after an acute hypercapnic exacerbation of COPD requiring NIV.
- pH value >7.35.
Key exclusion criteria (9 listed)
- BMI >30 kg/m2
- Clinically significant obstructive sleep apnea syndrome (patients in whom there was a clinical suspicion of OSA syndrome based on clinical review or overnight oximetry will go further testing with limited respiratory polygraphy)
- Neuromuscular or chest wall diseases
- Need for intubation and invasive mechanical ventilation during exacerbation
- Use of home non-invasive mechanical ventilation or CPAP
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 |
|---|---|---|
| Group 1: NHF/LTOTPatients assigned to this group will start NHF (Nasal High Flow) + oxygen therapy at home and undergo a preliminary trial with NHF to set the optimal flow using the MyAIRVO 3 (Fisher \& Paykel Healthcare, Auckland, New Zealand) with Optiflow+Duet interface. Patients assigned to this group will be required to use NHF for a minimum of 6 hours per night during sleep, while no restrictions will be set on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the control respiratory strategy (HMV+LTOT) will begin. | Device | Group 1 |
| Group 2: HMV/LTOTPatients assigned to this group will start home treatment with HMV (Home Mechanical Ventilation) + oxygen therapy and will be treated with HMV using a pressure support (PS) ventilator. HMV will be administered via nasal mask or full face mask according to patients' preference. Patients assigned to this group will be required to use HMV for a minimum of 6 hours per night in addition to daily home oxygen therapy for at least 15 hours. Moreover, no restrictions will be imposed on the duration of use or the times of day to use the device. Patients will continue this treatment for a period of 3 months. At the end of the 3 months, there will be a one-week wash-out period, after which treatment with the studied respiratory strategy (NHF+LTOT) will begin. | Device | Group 2 |
Primary outcome
Evaluation of the non-inferiority of the change in PaCO2 levels measured during treatment with NHF respiratory support compared to HMV respiratory support, both associated with standard oxygen therapy.
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Unity of measurement: mmHg
12 secondary outcomes
Evaluation of the time required for setting up and adjusting the two respiratory strategies.
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of PaO2 levels measured via arterial blood gas analysis
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
FVC, FEV1
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of exercise capacity measured using the 6-minute walk test (6MWT)
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of dyspnea measured using the Medical Research Council Dyspnea score
Time frame: aT0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of quality of life measured using the St. George's Respiratory Questionnaire
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of quality of sleep measured using the Pittsburg Sleep Quality Index
Time frame: T0 (baseline), T1 (+3months), T2 (+6months)
Evaluation of compliance to respiratory supports measured by downloading usage data from the respiratory support.
Time frame: T1 (+3months), T2 (+6months)
Evaluation of tolerance to respiratory supports meauserd using visual analog scales
Time frame: T1 (+3months), T2 (+6months)
Evaluation of frequency of exacerbations measured by counting the numbers of exacerbations occurred.
Time frame: three, six and 12 month since the beginning of the treatment
Evaluation of severity of exacerbations and subsequent hospitalizations measured by counting the number of exacerbations that required hospitalizations
Time frame: T1 (+3months), T2 (+6months) and T3 (+12months)
Evaluation of survival measured by mortality analysis
Time frame: T1 (+3months), T2 (+6months) and T3 (+12 months)
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 15 Jul 2025.
- Background: PubMed 28528348Murphy PB, Rehal S, Arbane G, Bourke S, Calverley PMA, Crook AM, Dowson L, Duffy N, Gibson GJ, Hughes PD, Hurst JR, Lewis KE, Mukherjee R, Nickol A, Oscroft N, Patout M, Pepperell J, Smith I, Stradling JR, Wedzicha JA, Polkey MI, Elliott MW, Hart N. Effect of Home Noninvasive Ventilation With Oxygen Therapy vs Oxygen Therapy Alone on Hospital Readmission or Death After an Acute COPD Exacerbation: A Randomized Clinical Trial. JAMA. 2017 Jun 6;317(21):2177-2186. doi: 10.1001/jama.2017.4451.
- Background: PubMed 31467119Ergan B, Oczkowski S, Rochwerg B, Carlucci A, Chatwin M, Clini E, Elliott M, Gonzalez-Bermejo J, Hart N, Lujan M, Nasilowski J, Nava S, Pepin JL, Pisani L, Storre JH, Wijkstra P, Tonia T, Boyd J, Scala R, Windisch W. European Respiratory Society guidelines on long-term home non-invasive ventilation for management of COPD. Eur Respir J. 2019 Sep 28;54(3):1901003. doi: 10.1183/13993003.01003-2019. Print 2019 Sep.
- Background: PubMed 34649974Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
- Background: PubMed 29713153Storgaard 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.
- Background: PubMed 36861118Weinreich UM, Juhl KS, Soby Christophersen M, Gundestrup S, Hanifa MA, Jensen K, Andersen FD, Hilberg O, Storgaard LH. The Danish respiratory society guideline for long-term high flow nasal cannula treatment, with or without supplementary oxygen. Eur Clin Respir J. 2023 Feb 23;10(1):2178600. doi: 10.1080/20018525.2023.2178600. eCollection 2023.
- Background: PubMed 28459282Pisani L, Vega ML. Use of Nasal High Flow in Stable COPD: Rationale and Physiology. COPD. 2017 Jun;14(3):346-350. doi: 10.1080/15412555.2017.1315715. Epub 2017 May 1.
- 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.
Lara Pisani, Prof.ssa principal investigator
University of Bologna
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1: NHF/LTOT and Group 2: HMV/LTOT in people with COPD and Hypercapnia, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 5 sites in Italy.
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 9 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 15 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 5 sites in Italy. 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 Lara Pisani, Prof.ssa (0512143257, lara.pisani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the non-inferiority of the change in PaCO2 levels measured during treatment with NHF respiratory support compared to HMV respiratory support, both associated with standard oxygen therapy. (time frame: T0 (baseline), T1 (+3months), T2 (+6months)). 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 NCT07065799, which also lists 6 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 15 Jul 2025.