Effect of AIRVO Heated Humidification in Bronchiectasis

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico130 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Bronchiectasis Adult

Interventions

Over-night treatment with myAIRVO2DEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (21)

Outcomes

Primary Outcomes

Pulmonary exacerbations

Number of pulmonary exacerbations

Time frame: baseline - 12 months

Secondary Outcomes

Pulmonary exacerbations requiring hospitalization

Number of pulmonary exacerbations requiring hospitalization

Time frame: baseline - 12 months

Time to first pulmonary exacerbation

Time occurring from the randomization to the first pulmonary exacerbation

Time frame: Up to 12 months. From date of randomization until the date of first documented pulmonary exacerbation

Time to first hospitalization for exacerbation

Time occurring from the randomization to the first exacerbation requiring hospitalization

Time frame: Up to 12 months.From date of randomization until the date of first documented hospitalization for pulmonary exacerbation

Days with symptoms of exacerbation

Number of days the patient showed symptoms of exacerbation

Time frame: baseline - 12 months

Days of anibiotic treatment for exacerbation

Number of days of antibiotic treatment for exacerbation

Time frame: baseline - 12 months

Patients requiring de novo oxygen therapy

Number of patients starting de novo oxygen treatment

Time frame: baseline - 12 months

Quality-of-Life-Bronchiectasis Questionnaire, that measures health-related quality of life

Data from ClinicalTrials.gov

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IRCCS Humanitas Research Hospital, Department of Biomedical Sciences, Humanitas University,

Rozzano, Milano, 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, Italy

Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit

Tradate, Varese, 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

Milan, Italy

Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi

Milan, Italy

...and 11 more locations

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.

Time frame: baseline - 6 and 12 months

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.

Time frame: baseline - 6 and 12 months

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.

Time frame: baseline - 6 and 12 months

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.

Time frame: baseline - 6 and 12 months

Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1)

Change in FEV1, measured by spirometry

Time frame: baseline - 6 and 12 months

Pulmonary function as change in Forced Vital Capacity (FVC)

Change in FVC, measured by spirometry

Time frame: baseline - 6 and 12 months

Mortality

All-cause mortality

Time frame: baseline - 12 months

Mortality due to respiratory causes

Mortality rate caused by respiratory disease

Time frame: baseline - 12 months

Adverse events

Frequency and severity of adverse events

Time frame: baseline - 12 months

Non-use of AIRVO therapy

Frequency of permanent or temporary AIRVO therapy stopping

Time frame: baseline - 12 months