Status:
COMPLETED
Effect of AIRVO Heated Humidification in Bronchiectasis
Lead Sponsor:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborating Sponsors:
ASST Fatebenefratelli Sacco
Fondazione IRCCS Policlinico San Matteo di Pavia
Conditions:
Bronchiectasis Adult
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT04102774
Start Date
June 20 2019
End Date
January 31 2025
Last Update
May 14 2025
Active Locations (21)
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1
IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Humanitas University,
Rozzano, Milano, Italy
2
Divisione di Pneumologia riabilitativa e Laboratorio di Citoimmunopatologia, Biochimica dell'apparato respiratorio, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
Veruno, Novara, Italy
3
Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit
Tradate, Varese, Italy
4
U.O.C Pneumologia e UTIP, Ospedale S. Donato
Arezzo, Italy