Effect of AIRVO Heated Humidification in Bronchiectasis

Study Overview
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Brief Summary
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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
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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).

Official Title
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Multicenter, Pragmatic, Randomized, Controlled Trial to Assess the Efficacy and Safety of Nocturnal Humidification Therapy in Patients With Bronchiectasis: the AIRVO-BX Study

Conditions
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Bronchiectasis Adult

Intervention / Treatment
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* Device: Over-night treatment with myAIRVO2


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All the patients meeting inclusion/esclusion criteria will be enrolled and randomized into one of the two arms. The control arm will receive standard therapy. The treatment arm will receive standard therapy + long-term humidification therapy with myAIRVO2 at home overnight.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myAIRVO2<br>Patients will receive a myAIRVO2 at home over-night with humidifier on top of standard therapy for bronchiectasis according to international guidelines (ERS 2017). | Device: Over-night treatment with myAIRVO2<br>* 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.<br>|
| No Intervention: Control<br>Patients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary exacerbations | Number of pulmonary exacerbations | baseline - 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary exacerbations requiring hospitalization | Number of pulmonary exacerbations requiring hospitalization | baseline - 12 months | 
| 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 | 
| 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 | 
| Days with symptoms of exacerbation | Number of days the patient showed symptoms of exacerbation | baseline - 12 months | 
| Days of anibiotic treatment for exacerbation | Number of days of antibiotic treatment for exacerbation | baseline - 12 months | 
| Patients requiring de novo oxygen therapy | Number of patients starting de novo oxygen treatment | baseline - 12 months | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1) | Change in FEV1, measured by spirometry | baseline - 6 and 12 months | 
| Pulmonary function as change in Forced Vital Capacity (FVC) | Change in FVC, measured by spirometry | baseline - 6 and 12 months | 
| Mortality | All-cause mortality | baseline - 12 months | 
| Mortality due to respiratory causes | Mortality rate caused by respiratory disease | baseline - 12 months | 
| Adverse events | Frequency and severity of adverse events | baseline - 12 months | 
| Non-use of AIRVO therapy | Frequency of permanent or temporary AIRVO therapy stopping | baseline - 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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airway warm humidification, exacerbation, airway clearance