Brief Title
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
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).
Study Type
Interventional
Primary Outcome
Pulmonary exacerbations
Secondary Outcome
Pulmonary exacerbations requiring hospitalization
Condition
Bronchiectasis Adult
Intervention
Over-night treatment with myAIRVO2
Study Arms / Comparison Groups
myAIRVO2
Description: Patients will receive a myAIRVO2 at home over-night with humidifier on top of standard therapy for bronchiectasis according to international guidelines (ERS 2017).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
130
Start Date
June 20, 2019
Completion Date
June 20, 2022
Primary Completion Date
June 20, 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Stefano Aliberti, MD, 0039255033789, [email protected]
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT04102774
Organization ID
AIRVO-BX
Responsible Party
Sponsor
Study Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
Azienda Ospedaliera San Gerardo di Monza
Study Sponsor
Stefano Aliberti, MD, Principal Investigator, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
Verification Date
September 2019