Effect of AIRVO Heated Humidification in Bronchiectasis

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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