The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
BX
1 other identifier
interventional
160
1 country
1
Brief Summary
The study is intended to understand the benefit of Long Term Home care Therapy with nasal High flow in Bronchiectasis patients at home. Primary end point is to evaluate daily life compared to usual care and secondary is to evaluate the changes in lung function
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 4, 2019
CompletedFirst Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 29, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2020
CompletedOctober 29, 2019
October 1, 2019
6 months
October 21, 2019
October 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Improvment Daily Life
measurement via questionary SGRQ
1 year
measurement of Sputum production
Microbiological Mesurement of sputum
1 year
measurement Exercise tolerance
measurement with 6 minutes walking test
1 year
Number of missed working or school day
Calculation of days of sick
1 year
time from first exacerbations
measurement of time dalay from last exacerbation
1 year
number of exacerbations including their durations and severity
counting form their clinic diary of number of exacerbation
1 year
Secondary Outcomes (3)
Evaluation of Arterial Blood Glass
1 year
Unit of Nitric Oxide
1 year
Evaluation of Reactive C-Protein
1 year
Study Arms (2)
Therapy with high flow humidification
EXPERIMENTALThe patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations
Therapy with usual care
NO INTERVENTIONThe patients will be under usual care for observational
Interventions
myAirvo2 gives at home for long therapy treatment
Eligibility Criteria
You may qualify if:
- Diagnosis of Bronchiectasis on HRCT
- Optimization of Therapy for at least 15 days before enrollment
- Autonomous patients with possibilities of practicing rehabilitations cycles
You may not qualify if:
- OSAS (ODI\>10/h)
- HOME NIV
- PH\<7,35 - paO2\< 60mmHg, paCo2\> 55 mmHg
- Lung cancer
- Contraindication to high-flow nasal cannula (hfnc)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rosa Cauteruccio
Napoli, 80131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Director Giuseppe Fiorentino
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 29, 2019
Study Start
September 4, 2019
Primary Completion
March 3, 2020
Study Completion
September 3, 2020
Last Updated
October 29, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL