Effect of AIRVO Heated Humidification in Bronchiectasis (AIRVO-BX)

  • STATUS
    Recruiting
  • End date
    May 31, 2024
  • participants needed
    130
  • sponsor
    Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Updated on 4 October 2022

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.

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).

Details
Condition Bronchiectasis Adult
Treatment Over-night treatment with myAIRVO2
Clinical Study IdentifierNCT04102774
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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