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Bronchiectasis AdultAIRVO-BXNCT04102774

Effect of AIRVO Heated Humidification in Bronchiectasis

A study testing Over-night treatment with myAIRVO2 in people with Bronchiectasis Adult, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 21 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of the study is to investigate whether long-term heated humidification therapy (AIRVO) administrated for 1 year over-night on top of standard therapy can reduce the number of exacerbations in adults with non-cystic fibrosis bronchiectasis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchiectasis Adult
What is being tested?
Over-night treatment with myAIRVO2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
21 sitesItaly
Study dates
20 Jun 2019to 31 Jan 2025
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Radiological evidence of bronchiectasis evaluated through a CT-scan of the chest
  • 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

Who cannot join

  • Being enrolled in other intervention trials during the 12 months prior randomization
  • 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)
Show all 14Show fewer
  • 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

Trial locations and contacts

21 sites in 1 country.

21 sites in 1 country

Italy21 sites

  • U.O.C Pneumologia e UTIP, Ospedale S. Donato

    Arezzo

  • Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Alma Mater Studiorum, Università degli Studi di Bologna

    Bologna

  • Dipartimento di Medicina Clinica e Sperimentale, U.O. di Fisiopatologia Respiratoria, Allergologia e Immunologia polmonare, Università degli Studi di Catania

    Catania

  • Dipartimento di Scienze Mediche e Chirurgiche, Settore Malattie dell'Apparato Respiratorio, Università degli Studi di Foggia

    Foggia

  • 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, 20122

  • 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

  • Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi

    Milan

  • U.O.C. Pneumologia, ASST- Santi Paolo e Carlo, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano

    Milan

  • 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

  • U.O.C. Pneumologia SUN, Ospedale Monaldi

    Naples

  • Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova

    Padova

  • Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo

    Palermo

  • Dipartimento di Medicina Clinica e Sperimentale, U.O.C. di Clinica Pneumologica, Azienda Ospedaliero-Universitaria di Parma

    Parma

  • Dipartimento di Medicina Interna e Terapia Medica, Divisione di Malattie dell'Apparato Respiratorio, Fondazione IRCCS Policlinico San Matteo, Università degli Studi di Pavia

    Pavia

  • U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico

    Pavia

  • Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore

    Roma

  • IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Humanitas University,

    Rozzano, Milano

  • U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico

    Telese Terme

  • Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit

    Tradate, Varese

  • Struttura Complessa di Pneumologia, Ospedale di Cattinara, Azienda Sanitaria Universitaria Integrata di Trieste ex Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Tieste

    Trieste

  • 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

Other trials in Italy

About this study

Official title: Multicenter, Pragmatic, Randomized, Controlled Trial to Assess the Efficacy and Safety of Nocturnal Humidification Therapy in Patients With Bronchiectasis: the AIRVO-BX Study

The aim of the study is to investigate whether long-term heated humidification therapy (AIRVO) administrated for 1 year over-night on top of standard therapy can reduce the number of exacerbations in adults with non-cystic fibrosis bronchiectasis.

Read the detailed description

Bronchiectasis is a chronic condition characterized by an abnormal widened airways, mucus retention, cough, daily sputum, and frequent respiratory infections. The management of bronchiectasis includes prevention of exacerbations and lung infections along with airway clearance techniques.

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).

Being tested
Over-night treatment with myAIRVO2
Keywords
airway warm humidification, exacerbation, airway clearance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Over-night treatment with myAIRVO2Device

    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.

Study groups in NCT04102774
Study groupRoleWhat they receive
myAIRVO2ExperimentalPatients will receive a myAIRVO2 at home over-night with humidifier on top of standard therapy for bronchiectasis according to international guidelines (ERS 2017).
Receives: Device: Over-night treatment with myAIRVO2
ControlNo interventionPatients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pulmonary exacerbations

    Number of pulmonary exacerbations

    Measured: baseline - 12 months

Secondary outcomes (16)

  1. Pulmonary exacerbations requiring hospitalization

    Number of pulmonary exacerbations requiring hospitalization

    Measured: baseline - 12 months

  2. Time to first pulmonary exacerbation

    Time occurring from the randomization to the first pulmonary exacerbation

    Measured: Up to 12 months. From date of randomization until the date of first documented pulmonary exacerbation

  3. Time to first hospitalization for exacerbation

    Time occurring from the randomization to the first exacerbation requiring hospitalization

    Measured: Up to 12 months.From date of randomization until the date of first documented hospitalization for pulmonary exacerbation

  4. Days with symptoms of exacerbation

    Number of days the patient showed symptoms of exacerbation

    Measured: baseline - 12 months

  5. Days of anibiotic treatment for exacerbation

    Number of days of antibiotic treatment for exacerbation

    Measured: baseline - 12 months

  6. Patients requiring de novo oxygen therapy

    Number of patients starting de novo oxygen treatment

    Measured: baseline - 12 months

  7. Quality-of-Life-Bronchiectasis Questionnaire, that measures health-related quality of life

    We will measure changes in the score of Quality-of-Life-Bronchiectasis Questionnaire (QoL-B) completed by enrolled subjects at baseline and after 6 and 12 months.

    This disease-related questionnaire does not generate a total score, but a specific score for 8 different components: physical functioning domain, role functioning domain, vitality domain, emotional domain, social functioning domain, treatment burden domain, health perception domain and respiratory symptoms domain.

    For each component the scale range is 0 - 100, where higher scores correspond to better health status.

    Measured: baseline - 6 and 12 months

  8. St.George Respiratory Questionnaire, that measures health-related quality of life

    We will measure changes in the score of St.George Respiratory Questionnaire (SGRQ) completed by enrolled subjects at baseline and after 6 and 12 months.

    This questionnaire is structured into 3 main components: symptoms, activity and impacts.

    Scale range is 0-100, where lower scores correspond to the better health status.

    Each questionnaire response has a unique empirically derived "weight".

    Each component of the questionnaire is scored separately in three steps:

    1. The weights for all items with a positive responses are summed. ii The weights for missed items are deducted from the maximum possible weight for each component. The weights for all missed items are deducted from the maximum possible weight for the Total score. iii. The score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage The Total score is calculated in similar way.

    Measured: baseline - 6 and 12 months

  9. Bronchiectasis Health Questionnaire, that measures health-related quality of life

    We will measure changes in the score of Bronchiectasis Health Questionnaire (BHQ) completed by enrolled subjects at baseline and after 6 and 12 months.

    This disease-specific questionnaire generates a single total score. The maximum score is 79,42 and corresponds to a better health status, the minimum score is 26,77 and corresponds to a worse health status.

    Measured: baseline - 6 and 12 months

  10. Leicester Cough Questionnaire, that measures health-related quality of life

    We will measure changes in the score of Leicester Cough Questionnaire (LCQ) completed by enrolled subjects at baseline and after 6 and 12 months.

    This questionnaire consists of 19 items with a 7 point response scale. Each item is developed to assess impacts of cough on three main domains: physical, psychological and social.

    Scores are calculated as a mean of scores obtained for items of each domain (range 1 to 7).

    Total score is calculated by adding every single domain score (range 3-21). For both total and domains' scores higher values indicates better health status.

    Measured: baseline - 6 and 12 months

  11. Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1)

    Change in FEV1, measured by spirometry

    Measured: baseline - 6 and 12 months

  12. Pulmonary function as change in Forced Vital Capacity (FVC)

    Change in FVC, measured by spirometry

    Measured: baseline - 6 and 12 months

  13. Mortality

    All-cause mortality

    Measured: baseline - 12 months

  14. Mortality due to respiratory causes

    Mortality rate caused by respiratory disease

    Measured: baseline - 12 months

  15. Adverse events

    Frequency and severity of adverse events

    Measured: baseline - 12 months

  16. Non-use of AIRVO therapy

    Frequency of permanent or temporary AIRVO therapy stopping

    Measured: baseline - 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2019
  2. Study start20 Jun 2019
  3. Primary completion31 Jan 2025
  4. Study completion31 Jan 2025

Resources

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
All the patients meeting inclusion/esclusion criteria will be enrolled and randomized into one of the two arms. The control arm will receive standard therapy. The treatment arm will receive standard therapy + long-term humidification therapy with myAIRVO2 at home overnight.
Masking
None (open label)
Enrolment
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04102774
Sponsor's protocol ID
AIRVO-BX
Acronym
AIRVO-BX
Status last verified
May 2025
First submitted
18 Sep 2019
Last updated
14 May 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 18539721

  • 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.

    PubMed 20144858

  • 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.

    PubMed 28889110

Questions about this trial

What is this clinical trial studying?

A study testing Over-night treatment with myAIRVO2 in people with Bronchiectasis Adult, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 21 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 8 inclusion and 14 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 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 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?

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?

Pulmonary exacerbations (time frame: baseline - 12 months). 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 NCT04102774, which also lists 3 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 14 May 2025.

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