Clinical trial NCT04102774: Effect of AIRVO Heated Humidification in Bronchiectasis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis Adult
Keywords: airway warm humidification
exacerbation
airway clearance
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
Collaborators: name: ASST Fatebenefratelli Sacco
name: Fondazione IRCCS Policlinico San Matteo di Pavia
name: Ospedale Maggiore Di Trieste
name: Azienda Ospedaliero-Universitaria di Modena
name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Fondazione Salvatore Maugeri
name: Università degli Studi di Ferrara
name: Azienda Ospedaliero, Universitaria Pisana
name: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Ospedale San Paolo
name: Universita degli Studi di Catania
name: Azienda Ospedaliera di Padova
name: University of Palermo
name: Azienda Ospedaliero-Universitaria di Parma
name: University of Foggia
name: Monaldi Hospital
name: Fondazione Don Carlo Gnocchi Onlus
name: Ospedale San Donato
First posted: 2019-09-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pulmonary exacerbations
timeFrame: baseline - 12 months
Secondary outcomes:
measure: Pulmonary exacerbations requiring hospitalization
timeFrame: baseline - 12 months
measure: Time to first pulmonary exacerbation
timeFrame: Up to 12 months. From date of randomization until the date of first documented pulmonary exacerbation
measure: Time to first hospitalization for exacerbation
timeFrame: Up to 12 months.From date of randomization until the date of first documented hospitalization for pulmonary exacerbation
measure: Days with symptoms of exacerbation
timeFrame: baseline - 12 months
measure: Days of anibiotic treatment for exacerbation
timeFrame: baseline - 12 months
measure: Patients requiring de novo oxygen therapy
timeFrame: baseline - 12 months
measure: Quality-of-Life-Bronchiectasis Questionnaire, that measures health-related quality of life
timeFrame: baseline - 6 and 12 months
measure: St.George Respiratory Questionnaire, that measures health-related quality of life
timeFrame: baseline - 6 and 12 months
measure: Bronchiectasis Health Questionnaire, that measures health-related quality of life
timeFrame: baseline - 6 and 12 months
measure: Leicester Cough Questionnaire, that measures health-related quality of life
timeFrame: baseline - 6 and 12 months
measure: Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: baseline - 6 and 12 months
measure: Pulmonary function as change in Forced Vital Capacity (FVC)
timeFrame: baseline - 6 and 12 months
measure: Mortality
timeFrame: baseline - 12 months
measure: Mortality due to respiratory causes
timeFrame: baseline - 12 months
measure: Adverse events
timeFrame: baseline - 12 months
measure: Non-use of AIRVO therapy
timeFrame: baseline - 12 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Humanitas University,
state: Milano
city: Veruno
country: Italy
facility: 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
state: Novara
city: Tradate
country: Italy
facility: Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit
state: Varese
city: Arezzo
country: Italy
facility: U.O.C Pneumologia e UTIP, Ospedale S. Donato
city: Bologna
country: Italy
facility: Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Alma Mater Studiorum, Università degli Studi di Bologna
city: Catania
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale, U.O. di Fisiopatologia Respiratoria, Allergologia e Immunologia polmonare, Università degli Studi di Catania
city: Foggia
country: Italy
facility: Dipartimento di Scienze Mediche e Chirurgiche, Settore Malattie dell'Apparato Respiratorio, Università degli Studi di Foggia
city: Milano
country: Italy
facility: Dipartimento di Scienze biomediche e cliniche "Luigi Sacco" DIBIC, Università degli Studi di Milano, U.O.C Pneumologia, Ospedale L. Sacco - ASST Fatebenfratelli Sacco
city: Milano
country: Italy
facility: Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi
city: Milano
country: Italy
facility: U.O.C. Pneumologia, ASST- Santi Paolo e Carlo, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano
city: Milan
country: Italy
facility: 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
city: Modena
country: Italy
facility: 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
city: Napoli
country: Italy
facility: U.O.C. Pneumologia SUN, Ospedale Monaldi
city: Padova
country: Italy
facility: Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova
city: Palermo
country: Italy
facility: Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo
city: Parma
country: Italy
facility: Dipartimento di Medicina Clinica e Sperimentale, U.O.C. di Clinica Pneumologica, Azienda Ospedaliero-Universitaria di Parma
city: Pavia
country: Italy
facility: Dipartimento di Medicina Interna e Terapia Medica, Divisione di Malattie dell'Apparato Respiratorio, Fondazione IRCCS Policlinico San Matteo, Università degli Studi di Pavia
city: Pavia
country: Italy
facility: U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
city: Roma
country: Italy
facility: Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
city: Telese Terme
country: Italy
facility: U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
city: Trieste
country: Italy
facility: Struttura Complessa di Pneumologia, Ospedale di Cattinara, Azienda Sanitaria Universitaria Integrata di Trieste ex Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Tieste
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Francesco Blasi, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.