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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