Effect of AIRVO Heated Humidification in Bronchiectasis

NCT04102774 | Completed

• 1 other identifier: AIRVO-BX
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 21

Brief 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.

Conditions

Bronchiectasis Adult

Keywords

airway warm humidification; exacerbation; airway clearance

Outcome Measures

Primary Outcomes (1)

• Pulmonary exacerbations

  Number of pulmonary exacerbations

  baseline - 12 months

Secondary Outcomes (16)

• Pulmonary exacerbations requiring hospitalization

  baseline - 12 months

• Time to first pulmonary exacerbation

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

• Time to first hospitalization for exacerbation

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

• Days with symptoms of exacerbation

  baseline - 12 months

• Days of anibiotic treatment for exacerbation

  baseline - 12 months

Study Arms (2)

myAIRVO2

EXPERIMENTAL

Patients will receive a myAIRVO2 at home over-night with humidifier on top of standard therapy for bronchiectasis according to international guidelines (ERS 2017).

Device: Over-night treatment with myAIRVO2

Control

NO INTERVENTION

Patients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017).

Interventions

Over-night treatment with myAIRVO2 DEVICE

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.

myAIRVO2

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead
• ASST Fatebenefratelli Sacco: collaborator
• Fondazione IRCCS Policlinico San Matteo di Pavia: collaborator
• Ospedale Maggiore Di Trieste: collaborator
• Azienda Ospedaliero-Universitaria di Modena: collaborator
• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: collaborator
• Fondazione Salvatore Maugeri: collaborator
• Università degli Studi di Ferrara: collaborator
• Azienda Ospedaliero, Universitaria Pisana: collaborator
• IRCCS Azienda Ospedaliero-Universitaria di Bologna: collaborator
• Ospedale San Paolo: collaborator
• Universita degli Studi di Catania: collaborator
• Azienda Ospedaliera di Padova: collaborator
• University of Palermo: collaborator
• Azienda Ospedaliero-Universitaria di Parma: collaborator
• University of Foggia: collaborator
• Monaldi Hospital: collaborator
• Fondazione Don Carlo Gnocchi Onlus: collaborator
• Ospedale San Donato: collaborator

Study Sites (21)

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

Rozzano, Milano, Italy

Location

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

Location

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

Tradate, Varese, Italy

Location

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

Arezzo, Italy

Location

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

Bologna, Italy

Location

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

Catania, Italy

Location

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

Foggia, Italy

Location

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, Italy

Location

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

Location

Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi

Milan, Italy

Location

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

Milan, Italy

Location

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

Location

U.O.C. Pneumologia SUN, Ospedale Monaldi

Napoli, Italy

Location

Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova

Padua, Italy

Location

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

Palermo, Italy

Location

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

Parma, Italy

Location

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

Location

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

Pavia, Italy

Location

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

Roma, Italy

Location

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

Telese Terme, Italy

Location

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

Trieste, Italy

Location

Related Publications (3)

• 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.

  PMID: 18539721 BACKGROUND

• 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.

  PMID: 20144858 BACKGROUND

• 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.

  PMID: 28889110 BACKGROUND

Study Officials

• Francesco Blasi, Prof

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 18, 2019
• First Posted: September 25, 2019
• Study Start: June 20, 2019
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (21)