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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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
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
Start Date
June 20, 2019
Primary Completion Date
January 31, 2025
Completion Date
January 31, 2025
Last Updated
May 14, 2025
130
ACTUAL participants
Over-night treatment with myAIRVO2
DEVICE
Lead Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
NCT06670937
NCT06760273
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT04538859