Effect of AIRVO Heated Humidification in Bronchiectasis

Bronchiectasis Adult Clinical Trial

— AIRVO-BX  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04102774
• Other study ID #: AIRVO-BX
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 20, 2019
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2023
• Source: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 130
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult

Intervention

Device:
• Over-night treatment with myAIRVO2
Gas flow will be set between 20 and 30 l/min, according to patient's comfort, and administrated via nasal canula. Temperature will be set at 37°C. If the patient was already in nocturnal oxygen therapy FiO2 will be set according to the prescription.

Locations

Country	Name	City	State
Italy	U.O.C Pneumologia e UTIP, Ospedale S. Donato	Arezzo
Italy	Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Alma Mater Studiorum, Università degli Studi di Bologna	Bologna
Italy	Dipartimento di Medicina Clinica e Sperimentale, U.O. di Fisiopatologia Respiratoria, Allergologia e Immunologia polmonare, Università degli Studi di Catania	Catania
Italy	Dipartimento di Scienze Mediche e Chirurgiche, Settore Malattie dell'Apparato Respiratorio, Università degli Studi di Foggia	Foggia
Italy	Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico	Milan
Italy	Dipartimento di Scienze biomediche e cliniche "Luigi Sacco" DIBIC, Università degli Studi di Milano, U.O.C Pneumologia, Ospedale L. Sacco - ASST Fatebenfratelli Sacco	Milano
Italy	Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi	Milano
Italy	U.O.C. Pneumologia, ASST- Santi Paolo e Carlo, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano	Milano
Italy	Struttura Complessa di Malattie dell'apparato Respiratorio e Centro delle Malattie Rare del Polmone, Dipartimento di Scienze Mediche e Chirurgiche Materno-Infantili e dell'Adulto, Università degli Studi di Modena e Reggio Emilia, Azienda Ospedaliero-Unive	Modena
Italy	U.O.C. Pneumologia SUN, Ospedale Monaldi	Napoli
Italy	Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova	Padova
Italy	Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo	Palermo
Italy	Dipartimento di Medicina Clinica e Sperimentale, U.O.C. di Clinica Pneumologica, Azienda Ospedaliero-Universitaria di Parma	Parma
Italy	Dipartimento di Medicina Interna e Terapia Medica, Divisione di Malattie dell'Apparato Respiratorio, Fondazione IRCCS Policlinico San Matteo, Università degli Studi di Pavia	Pavia
Italy	U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico	Pavia
Italy	Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore	Roma
Italy	IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Humanitas University,	Rozzano	Milano
Italy	U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico	Telese Terme
Italy	Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit	Tradate	Varese
Italy	Struttura Complessa di Pneumologia, Ospedale di Cattinara, Azienda Sanitaria Universitaria Integrata di Trieste ex Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Tieste	Trieste
Italy	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

Sponsors (19)

Lead Sponsor

Collaborator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

ASST Fatebenefratelli Sacco, Azienda Ospedaliera di Padova, Azienda Ospedaliero, Universitaria Pisana, Azienda Ospedaliero-Universitaria di Modena, Azienda Ospedaliero-Universitaria di Parma, Fondazione Don Carlo Gnocchi Onlus, Fondazione IRCCS Policlinico San Matteo di Pavia, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione Salvatore Maugeri, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Monaldi Hospital, Ospedale Maggiore Di Trieste, Ospedale San Donato, Ospedale San Paolo, Universita degli Studi di Catania, Università degli Studi di Ferrara, University of Foggia, University of Palermo

Country where clinical trial is conducted

Italy, 

References & Publications (3)

Hasani A, Chapman TH, McCool D, Smith RE, Dilworth JP, Agnew JE. Domiciliary humidification improves lung mucociliary clearance in patients with bronchiectasis. Chron Respir Dis. 2008;5(2):81-6. doi: 10.1177/1479972307087190. — View Citation

Polverino E, Goeminne PC, McDonnell MJ, Aliberti S, Marshall SE, Loebinger MR, Murris M, Canton R, Torres A, Dimakou K, De Soyza A, Hill AT, Haworth CS, Vendrell M, Ringshausen FC, Subotic D, Wilson R, Vilaro J, Stallberg B, Welte T, Rohde G, Blasi F, Elborn S, Almagro M, Timothy A, Ruddy T, Tonia T, Rigau D, Chalmers JD. European Respiratory Society guidelines for the management of adult bronchiectasis. Eur Respir J. 2017 Sep 9;50(3):1700629. doi: 10.1183/13993003.00629-2017. Print 2017 Sep. — View Citation

Rea H, McAuley S, Jayaram L, Garrett J, Hockey H, Storey L, O'Donnell G, Haru L, Payton M, O'Donnell K. The clinical utility of long-term humidification therapy in chronic airway disease. Respir Med. 2010 Apr;104(4):525-33. doi: 10.1016/j.rmed.2009.12.016. Epub 2010 Feb 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary exacerbations	Number of pulmonary exacerbations	baseline - 12 months
Secondary	Pulmonary exacerbations requiring hospitalization	Number of pulmonary exacerbations requiring hospitalization	baseline - 12 months
Secondary	Time to first pulmonary exacerbation	Time occurring from the randomization to the first pulmonary exacerbation	Up to 12 months. From date of randomization until the date of first documented pulmonary exacerbation
Secondary	Time to first hospitalization for exacerbation	Time occurring from the randomization to the first exacerbation requiring hospitalization	Up to 12 months.From date of randomization until the date of first documented hospitalization for pulmonary exacerbation
Secondary	Days with symptoms of exacerbation	Number of days the patient showed symptoms of exacerbation	baseline - 12 months
Secondary	Days of anibiotic treatment for exacerbation	Number of days of antibiotic treatment for exacerbation	baseline - 12 months
Secondary	Patients requiring de novo oxygen therapy	Number of patients starting de novo oxygen treatment	baseline - 12 months
Secondary	Quality-of-Life-Bronchiectasis Questionnaire, that measures health-related quality of life	We will measure changes in the score of Quality-of-Life-Bronchiectasis Questionnaire (QoL-B) completed by enrolled subjects at baseline and after 6 and 12 months.; This disease-related questionnaire does not generate a total score, but a specific score for 8 different components: physical functioning domain, role functioning domain, vitality domain, emotional domain, social functioning domain, treatment burden domain, health perception domain and respiratory symptoms domain.; For each component the scale range is 0 - 100, where higher scores correspond to better health status.	baseline - 6 and 12 months
Secondary	St.George Respiratory Questionnaire, that measures health-related quality of life	We will measure changes in the score of St.George Respiratory Questionnaire (SGRQ) completed by enrolled subjects at baseline and after 6 and 12 months.; This questionnaire is structured into 3 main components: symptoms, activity and impacts.; Scale range is 0-100, where lower scores correspond to the better health status.; Each questionnaire response has a unique empirically derived "weight".; Each component of the questionnaire is scored separately in three steps: i. The weights for all items with a positive responses are summed. ii The weights for missed items are deducted from the maximum possible weight for each component. The weights for all missed items are deducted from the maximum possible weight for the Total score.; iii. The score is calculated by dividing the summed weights by the adjusted maximum possible weight for that component and expressing the result as a percentage The Total score is calculated in similar way.	baseline - 6 and 12 months
Secondary	Bronchiectasis Health Questionnaire, that measures health-related quality of life	We will measure changes in the score of Bronchiectasis Health Questionnaire (BHQ) completed by enrolled subjects at baseline and after 6 and 12 months.; This disease-specific questionnaire generates a single total score. The maximum score is 79,42 and corresponds to a better health status, the minimum score is 26,77 and corresponds to a worse health status.	baseline - 6 and 12 months
Secondary	Leicester Cough Questionnaire, that measures health-related quality of life	We will measure changes in the score of Leicester Cough Questionnaire (LCQ) completed by enrolled subjects at baseline and after 6 and 12 months.; This questionnaire consists of 19 items with a 7 point response scale. Each item is developed to assess impacts of cough on three main domains: physical, psychological and social.; Scores are calculated as a mean of scores obtained for items of each domain (range 1 to 7).; Total score is calculated by adding every single domain score (range 3-21). For both total and domains' scores higher values indicates better health status.	baseline - 6 and 12 months
Secondary	Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1)	Change in FEV1, measured by spirometry	baseline - 6 and 12 months
Secondary	Pulmonary function as change in Forced Vital Capacity (FVC)	Change in FVC, measured by spirometry	baseline - 6 and 12 months
Secondary	Mortality	All-cause mortality	baseline - 12 months
Secondary	Mortality due to respiratory causes	Mortality rate caused by respiratory disease	baseline - 12 months
Secondary	Adverse events	Frequency and severity of adverse events	baseline - 12 months
Secondary	Non-use of AIRVO therapy	Frequency of permanent or temporary AIRVO therapy stopping	baseline - 12 months