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Effect of AIRVO Heated Humidification in Bronchiectasis (AIRVO-BX)

Primary Purpose

Bronchiectasis Adult

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Over-night treatment with myAIRVO2
Sponsored by
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis Adult focused on measuring airway warm humidification, exacerbation, airway clearance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Unità Operativa di Riabilitazione Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit , Istituto Scientifico di Lumezzane
  • 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 ScientificoRecruiting
  • Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società BenefitRecruiting
  • U.O.C Pneumologia e UTIP, Ospedale S. DonatoRecruiting
  • Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Alma Mater Studiorum, Università degli Studi di BolognaRecruiting
  • Dipartimento di Medicina Clinica e Sperimentale, U.O. di Fisiopatologia Respiratoria, Allergologia e Immunologia polmonare, Università degli Studi di CataniaRecruiting
  • Dipartimento di Scienze Mediche e Chirurgiche, Settore Malattie dell'Apparato Respiratorio, Università degli Studi di FoggiaRecruiting
  • Dipartimento di Scienze biomediche e cliniche "Luigi Sacco" DIBIC, Università degli Studi di Milano, U.O.C Pneumologia, Ospedale L. Sacco - ASST Fatebenfratelli Sacco
  • Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don GnocchiRecruiting
  • U.O.C. Pneumologia, ASST- Santi Paolo e Carlo, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di MilanoRecruiting
  • Department of Pathophysiology and Transplantation, University of Milan Internal Medicine Department, Respiratory Unit and Cystic Fibrosis Adult Center Fondazione IRCCS Ca' Granda Ospedale Maggiore PoliclinicoRecruiting
  • 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-UniveRecruiting
  • U.O.C. Pneumologia SUN, Ospedale MonaldiRecruiting
  • Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova
  • Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo
  • Dipartimento di Medicina Clinica e Sperimentale, U.O.C. di Clinica Pneumologica, Azienda Ospedaliero-Universitaria di Parma
  • Dipartimento di Medicina Interna e Terapia Medica, Divisione di Malattie dell'Apparato Respiratorio, Fondazione IRCCS Policlinico San Matteo, Università degli Studi di PaviaRecruiting
  • U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere ScientificoRecruiting
  • Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro CuoreRecruiting
  • Struttura Complessa di Pneumologia, Ospedale di Cattinara, Azienda Sanitaria Universitaria Integrata di Trieste ex Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Tieste

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

myAIRVO2

Control

Arm 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).

Patients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017).

Outcomes

Primary Outcome Measures

Pulmonary exacerbations
Number of pulmonary exacerbations

Secondary Outcome Measures

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

Full Information

First Posted
September 18, 2019
Last Updated
October 16, 2023
Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
Azienda Ospedaliera San Gerardo di Monza, ASST Fatebenefratelli Sacco, Fondazione IRCCS Policlinico San Matteo di Pavia, Ospedale Maggiore Di Trieste, Azienda Ospedaliero-Universitaria di Modena, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione Salvatore Maugeri, Università degli Studi di Ferrara, Azienda Ospedaliero, Universitaria Pisana, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Ospedale San Paolo, Universita degli Studi di Catania, Azienda Ospedaliera di Padova, University of Palermo, Azienda Ospedaliero-Universitaria di Parma, University of Foggia, Monaldi Hospital, Fondazione Don Carlo Gnocchi Onlus, Ospedale San Donato
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1. Study Identification

Unique Protocol Identification Number
NCT04102774
Brief Title
Effect of AIRVO Heated Humidification in Bronchiectasis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2019 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Collaborators
Azienda Ospedaliera San Gerardo di Monza, ASST Fatebenefratelli Sacco, Fondazione IRCCS Policlinico San Matteo di Pavia, Ospedale Maggiore Di Trieste, Azienda Ospedaliero-Universitaria di Modena, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Fondazione Salvatore Maugeri, Università degli Studi di Ferrara, Azienda Ospedaliero, Universitaria Pisana, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Ospedale San Paolo, Universita degli Studi di Catania, Azienda Ospedaliera di Padova, University of Palermo, Azienda Ospedaliero-Universitaria di Parma, University of Foggia, Monaldi Hospital, Fondazione Don Carlo Gnocchi Onlus, Ospedale San Donato

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis Adult
Keywords
airway warm humidification, exacerbation, airway clearance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
myAIRVO2
Arm Type
Experimental
Arm 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).
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will receive standard therapy for bronchiectasis according to international guidelines (ERS 2017).
Intervention Type
Device
Intervention Name(s)
Over-night treatment with myAIRVO2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary exacerbations
Description
Number of pulmonary exacerbations
Time Frame
baseline - 12 months
Secondary Outcome Measure Information:
Title
Pulmonary exacerbations requiring hospitalization
Description
Number of pulmonary exacerbations requiring hospitalization
Time Frame
baseline - 12 months
Title
Time to first pulmonary exacerbation
Description
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
Title
Time to first hospitalization for exacerbation
Description
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
Title
Days with symptoms of exacerbation
Description
Number of days the patient showed symptoms of exacerbation
Time Frame
baseline - 12 months
Title
Days of anibiotic treatment for exacerbation
Description
Number of days of antibiotic treatment for exacerbation
Time Frame
baseline - 12 months
Title
Patients requiring de novo oxygen therapy
Description
Number of patients starting de novo oxygen treatment
Time Frame
baseline - 12 months
Title
Quality-of-Life-Bronchiectasis Questionnaire, that measures health-related quality of life
Description
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
Title
St.George Respiratory Questionnaire, that measures health-related quality of life
Description
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
Title
Bronchiectasis Health Questionnaire, that measures health-related quality of life
Description
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
Title
Leicester Cough Questionnaire, that measures health-related quality of life
Description
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
Title
Pulmonary function as change in Forced Expiratory Volume in 1 Second (FEV1)
Description
Change in FEV1, measured by spirometry
Time Frame
baseline - 6 and 12 months
Title
Pulmonary function as change in Forced Vital Capacity (FVC)
Description
Change in FVC, measured by spirometry
Time Frame
baseline - 6 and 12 months
Title
Mortality
Description
All-cause mortality
Time Frame
baseline - 12 months
Title
Mortality due to respiratory causes
Description
Mortality rate caused by respiratory disease
Time Frame
baseline - 12 months
Title
Adverse events
Description
Frequency and severity of adverse events
Time Frame
baseline - 12 months
Title
Non-use of AIRVO therapy
Description
Frequency of permanent or temporary AIRVO therapy stopping
Time Frame
baseline - 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Blasi, Prof
Phone
0039255033782
Email
francesco.blasi@unimi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Martina Santambrogio, PhD
Phone
00393393838807
Email
martina.santambrogio@policlinico.mi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Blasi, Prof
Organizational Affiliation
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unità Operativa di Riabilitazione Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit , Istituto Scientifico di Lumezzane
City
Lumezzane
State/Province
Brescia
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Vitacca, MD
Email
michele.vitacca@icsmaugeri.it
Facility Name
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
City
Veruno
State/Province
Novara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Balbi, MD
Email
bruno.balbi@icsmaugeri.it
Facility Name
Università degli Studi dell'Insubria e Istituti Clinici Scientifici Maugeri SpA - Società Benefit
City
Tradate
State/Province
Varese
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Spanevello, MD
Email
antonio.spanevello@icsmaugeri.it
Facility Name
U.O.C Pneumologia e UTIP, Ospedale S. Donato
City
Arezzo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele Scala, MD
Email
raffaele_scala@hotmail.com
Facility Name
Dipartimento di Medicina Specialistica Diagnostica e Sperimentale, Alma Mater Studiorum, Università degli Studi di Bologna
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Nava, MD
Email
stefano.nava@aosp.bo.it
Facility Name
Dipartimento di Medicina Clinica e Sperimentale, U.O. di Fisiopatologia Respiratoria, Allergologia e Immunologia polmonare, Università degli Studi di Catania
City
Catania
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nunzio Crimi, MD
Email
crimi@unict.it
Facility Name
Dipartimento di Scienze Mediche e Chirurgiche, Settore Malattie dell'Apparato Respiratorio, Università degli Studi di Foggia
City
Foggia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donato Lacedonia, MD
Email
donatolacedonia@gmail.com
Facility Name
Dipartimento di Scienze biomediche e cliniche "Luigi Sacco" DIBIC, Università degli Studi di Milano, U.O.C Pneumologia, Ospedale L. Sacco - ASST Fatebenfratelli Sacco
City
Milano
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierachille Santus, PhD
Email
pierachille.santus@unimi.it
Facility Name
Riabilitazione pneumologica, IRCCS Santa Maria nascente - fondazione don Gnocchi
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Banfi, MD
Email
pabanfi@dongnocchi.it
Facility Name
U.O.C. Pneumologia, ASST- Santi Paolo e Carlo, Ospedale San Paolo, Dipartimento di Scienze della Salute, Università degli Studi di Milano
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Centanni, MD
Email
stefano.centanni@unimi.it
Facility Name
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
City
Milan
ZIP/Postal Code
20122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Blasi, Prof
Phone
0039255033782
Email
francesco.blasi@unimi.it
First Name & Middle Initial & Last Name & Degree
Martina Santambrogio, PhD
Phone
00393393838807
Email
martina.santambrogio@policlinico.mi.it
Facility Name
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
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrico Clini, MD
Email
enrico.clini@unimore.it
Facility Name
U.O.C. Pneumologia SUN, Ospedale Monaldi
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cecilia Calabrese, MD
Email
ceciliacalabrese123@gmail.com
Facility Name
Struttura Complessa di Fisiopatologia Respiratoria, Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Vianello, MD
Email
andrea.vianello@sanita.padova.it
Facility Name
Dipartimento Biomedico di Medicina Interna e Specialistica, Università degli Studi di Palermo
City
Palermo
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salvatore Battaglia, MD
Email
salvatore.battaglia@unipa.it
Facility Name
Dipartimento di Medicina Clinica e Sperimentale, U.O.C. di Clinica Pneumologica, Azienda Ospedaliero-Universitaria di Parma
City
Parma
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Chetta, MD
Email
alfredoantonio.chetta@unipr.it
Facility Name
Dipartimento di Medicina Interna e Terapia Medica, Divisione di Malattie dell'Apparato Respiratorio, Fondazione IRCCS Policlinico San Matteo, Università degli Studi di Pavia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angelo Corsico, MD
Email
corsico@unipv.it
Facility Name
U.O. di Riabilitazione Specialistica Pneumologica, Istituti Clinici Scientifici Maugeri SpA - Società Benefit, Istituto di Ricovero e Cura a Carattere Scientifico
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piero Ceriana, MD
Email
piero.ceriana@icsmaugeri.it
Facility Name
Unità Operativa Complessa di Pneumologia, Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luca Richeldi, MD
Email
luca.richeldi@policlinicogemelli.it
Facility Name
Struttura Complessa di Pneumologia, Ospedale di Cattinara, Azienda Sanitaria Universitaria Integrata di Trieste ex Azienda Ospedaliero-Universitaria "Ospedali Riuniti" di Tieste
City
Trieste
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Confalonieri, MD
Email
marco.confalonieri@asuits.sanita.fvg.it

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
18539721
Citation
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.
Results Reference
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PubMed Identifier
20144858
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.
Results Reference
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PubMed Identifier
28889110
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.
Results Reference
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Effect of AIRVO Heated Humidification in Bronchiectasis

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