Respiratory Strategies in COPD Patients With Persistent Hypercapnia Following Exacerbation

NCT07065799 | Recruiting

• 1 other identifier: n° 22/2024/Disp/AOUBo
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 5

Brief 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 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

Conditions

COPD; Hypercapnia; Exacerbation Copd

Keywords

COPD; hypercapnia; NHF; HMV; PaCO2

Outcome Measures

Primary Outcomes (1)

• 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

  T0 (baseline), T1 (+3months), T2 (+6months)

Secondary Outcomes (12)

• Evaluation of the time required for setting up and adjusting the two respiratory strategies.

  T0 (baseline), T1 (+3months), T2 (+6months)

• Evaluation of PaO2 levels measured via arterial blood gas analysis

  T0 (baseline), T1 (+3months), T2 (+6months)

• FVC, FEV1

  T0 (baseline), T1 (+3months), T2 (+6months)

• Evaluation of exercise capacity measured using the 6-minute walk test (6MWT)

  T0 (baseline), T1 (+3months), T2 (+6months)

• Evaluation of dyspnea measured using the Medical Research Council Dyspnea score

  aT0 (baseline), T1 (+3months), T2 (+6months)

Study Arms (2)

Group 1

EXPERIMENTAL

NHF/LTOT

Device: Group 1: NHF/LTOT

Group 2

ACTIVE COMPARATOR

HMV/LTOT

Device: Group 2: HMV/LTOT

Interventions

Group 1: NHF/LTOT DEVICE

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 1

Group 2: HMV/LTOT DEVICE

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.

Group 2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• Presence of cognitive impairment that would prevent informed consent into the trial
• Patients with active and unstable coronary artery syndrome
• Patients suffering from malignancies

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• Azienda Sanitaria dell'Alto Adige: collaborator
• Ospedale San Donato: collaborator
• Azienda Unita Sanitaria Locale di Piacenza: collaborator
• Policlinico Universitario, Catania: collaborator
• Fondazione Salvatore Maugeri: collaborator

Study Sites (5)

Ospedale S Donato

Arezzo, Italy

RECRUITING

Bolzano Hospital

Bolzano, Italy

RECRUITING

Azienda Ospedaliera Universitaria Policlinico "G. Rodolico-Sn Marco"

Catania, Italy

RECRUITING

ICS Maugeri Spa Società Benefit IRCCS

Pavia, Italy

RECRUITING

Azienda Unità Sanitaria Locale

Piacenza, Italy

RECRUITING

Related Publications (6)

• 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.

  PMID: 28528348 BACKGROUND

• Ergan 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.

  PMID: 31467119 BACKGROUND

• Oczkowski 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.

  PMID: 34649974 BACKGROUND

• Storgaard 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.

  PMID: 29713153 BACKGROUND

• Weinreich 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.

  PMID: 36861118 BACKGROUND

• Pisani 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.

  PMID: 28459282 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypercapnia

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Lara Pisani, Prof.ssa

  University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lara Pisani, Prof.ssa

CONTACT

0512143257; lara.pisani@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: Multicenter, randomized, controlled, crossover, non-inferiority

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: July 15, 2025
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (5)