Effect of AIRVO Heated Humidification in Bronchiectasis
NCT ID: NCT04102774
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
130 participants
INTERVENTIONAL
2019-06-20
2025-01-31
Brief Summary
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Detailed Description
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Mucus composition and hydration are crucial to allow mucus transport along airways during respiratory physiotherapy.
Previous studies showed that long term humidification therapy increased airway clearance (Hasani et al. 2008) and reduced the number of exacerbations in patients with both bronchiectasis and Chronic Obstructive Pulmonary Disease (COPD) (Rea et al. 2010). myAIRVO2 system can deliver high-flow warm and humidified gases through a nasal cannula.
The aim of the present study to assess the effect of long-term use over-night of myAIRVO2 warm humidification in adults with bronchiectasis who experience at least 3 exacerbations/year still with optimized clinical and respiratory therapies.
In addition to their usual therapy, the treatment group will receive a myAIRVO2 humidifier at home deliver every day for one year over-night.
The gas flow setting will be set between 20 and 30 l/min based on patient preference, temperature will be 37°C and, for patients already in long-term oxygen therapy, FiO2 will be regulated according to patient's prescription.
The control group will continue to receive standard therapy for bronchiectasis according to international guidelines.
Patients will be screened during outpatient visits and, if they meet study criteria, they will be enrolled in the study. Once enrolled in the study, patients will be followed up every 3 months with 4 consecutive outpatient visits. The following endpoints will be assessed: exacerbations frequency, quality of life, pulmonary function and, for patients enrolled in the treatment group, myAIRVO2 use, and comfort.
Statistical analysis will be performed by Prof. Giovanni Sotgiu (University of Sassari - Italy).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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myAIRVO2
Patients will receive a myAIRVO2 at home over-night with humidifier on top of standard therapy for bronchiectasis according to international guidelines (ERS 2017).
Over-night treatment with myAIRVO2
Gas flow will be set between 20 and 30 l/min, according to patient's comfort, and administrated via nasal canula.
Temperature will be set at 37°C. If the patient was already in nocturnal oxygen therapy FiO2 will be set according to the prescription.
Control
Patients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017).
No interventions assigned to this group
Interventions
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Over-night treatment with myAIRVO2
Gas flow will be set between 20 and 30 l/min, according to patient's comfort, and administrated via nasal canula.
Temperature will be set at 37°C. If the patient was already in nocturnal oxygen therapy FiO2 will be set according to the prescription.
Eligibility Criteria
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Inclusion Criteria
* Daily sputum production
* Presence of at least 3 exacerbations requiring antibiotic therapy during the 12 months prior randomization
* Absence of exacerbations during the 28 days prior randomization
* Having the bronchiectasis management/therapy optimized according to international guidelines (ERS Polverino 2017) during the 12 months preceding randomization and no changes in therapy occurred during the 28 days prior randomization
* Airways clearance physiotherapy optimized and unchanged during the 12 months prior randomization
* Being able to use myAIRVO2 (assessed by study investigators)
* Given consent to inclusion in the study
Exclusion Criteria
* COPD or asthma recognized as main diseases by the study investigator
* Active smoker or ex-smoker who underwent smoking cessation during the 4 weeks prior randomization
* Any other disease or medical condition diagnosed during the 3 months prior randomization which can affect patients' safety
* Long-term treatment with non-invasive ventilation (NIV)
* Long-term night treatment with continuous positive airway pressure (CPAP)
* Tracheostomy
* Major haemoptysis (more than 300ml or requiring embolization or requiring blood transfusion) during the 6 weeks prior randomization
* Cystic fibrosis
* Traction bronchiectasis in the context of pulmonary fibrosis
* Lung cancer in the last 5 years
* Use of drugs that can modify mucus liquid content including mannitol, Hypertoinc saline, DNase, NAC
* Changes in the rehabilitation/respiratory therapy program during the 28 days before randomization
* Pregnant and brest-feeding women
18 Years
ALL
No
Sponsors
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ASST Fatebenefratelli Sacco
OTHER
Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Ospedale Maggiore Di Trieste
OTHER
Azienda Ospedaliero-Universitaria di Modena
OTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Fondazione Salvatore Maugeri
OTHER
Università degli Studi di Ferrara
OTHER
Azienda Ospedaliero, Universitaria Pisana
OTHER
IRCCS Azienda Ospedaliero-Universitaria di Bologna
OTHER
Ospedale San Paolo
OTHER
Universita degli Studi di Catania
OTHER
Azienda Ospedaliera di Padova
OTHER
University of Palermo
OTHER
Azienda Ospedaliero-Universitaria di Parma
OTHER
University of Foggia
OTHER
Monaldi Hospital
OTHER
Fondazione Don Carlo Gnocchi Onlus
OTHER
Ospedale San Donato
OTHER
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Francesco Blasi, Prof
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Locations
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IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Humanitas University,
Rozzano, Milano, Italy
Divisione di Pneumologia riabilitativa e Laboratorio di Citoimmunopatologia, Biochimica dell'apparato respiratorio, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
Veruno, Novara, Italy
Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit
Tradate, Varese, Italy
U.O.C Pneumologia e UTIP, Ospedale S. Donato
Arezzo, , Italy
Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Alma Mater Studiorum, Università degli Studi di Bologna
Bologna, , Italy
Dipartimento di Medicina Clinica e Sperimentale, U.O. di Fisiopatologia Respiratoria, Allergologia e Immunologia polmonare, Università degli Studi di Catania
Catania, , Italy
Dipartimento di Scienze Mediche e Chirurgiche, Settore Malattie dell'Apparato Respiratorio, Università degli Studi di Foggia
Foggia, , Italy
Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Dipartimento di Scienze biomediche e cliniche "Luigi Sacco" DIBIC, Università degli Studi di Milano, U.O.C Pneumologia, Ospedale L. Sacco - ASST Fatebenfratelli Sacco
Milan, , Italy
Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi
Milan, , Italy
U.O.C. Pneumologia, ASST- Santi Paolo e Carlo, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano
Milan, , Italy
Struttura Complessa di Malattie dell'apparato Respiratorio e Centro delle Malattie Rare del Polmone, Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero-Unive
Modena, , Italy
U.O.C. Pneumologia SUN, Ospedale Monaldi
Napoli, , Italy
Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova
Padua, , Italy
Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo
Palermo, , Italy
Dipartimento di Medicina Clinica e Sperimentale, U.O.C. di Clinica Pneumologica, Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Dipartimento di Medicina Interna e Terapia Medica, Divisione di Malattie dell'Apparato Respiratorio, Fondazione IRCCS Policlinico San Matteo, Università degli Studi di Pavia
Pavia, , Italy
U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
Pavia, , Italy
Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
Roma, , Italy
U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
Telese Terme, , Italy
Struttura Complessa di Pneumologia, Ospedale di Cattinara, Azienda Sanitaria Universitaria Integrata di Trieste ex Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Tieste
Trieste, , Italy
Countries
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References
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Hasani A, Chapman TH, McCool D, Smith RE, Dilworth JP, Agnew JE. Domiciliary humidification improves lung mucociliary clearance in patients with bronchiectasis. Chron Respir Dis. 2008;5(2):81-6. doi: 10.1177/1479972307087190.
Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9.
Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep.
Other Identifiers
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AIRVO-BX
Identifier Type: -
Identifier Source: org_study_id
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