CompletedNo phase
Effect of AIRVO Heated Humidification in Bronchiectasis
Key facts
- Who runs it
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Where
- Italy21 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 130 people enrolled
- Started
- 20 Jun 2019
- Ended
- 31 Jan 2025
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- Over-night treatment with myAIRVO2
- Record updated
- 14 May 2025
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Being enrolled in other intervention trials during the 12 months prior randomization
- 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)
- Major haemoptysis (more than 300ml or requiring embolization or requiring blood transfusion) during the 6 weeks prior randomization
- 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
- COPD or asthma recognized as main diseases by the study investigator
- Lung cancer in the last 5 years
- Tracheostomy
- Cystic fibrosis
- Traction bronchiectasis in the context of pulmonary fibrosis
- Pregnant and brest-feeding women
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- myAIRVO2Treatment being tested
Patients will receive a myAIRVO2 at home over-night with humidifier on top of standard therapy for bronchiectasis according to international guidelines (ERS 2017).
Treatment: Over-night treatment with myAIRVO2
- ControlNo study treatment, for comparison
Patients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017).
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- 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
- Record updated
- 14 May 2025