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The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)

The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04142827
Acronym
BX
Enrollment
160
Registered
2019-10-29
Start date
2019-09-04
Completion date
2020-09-03
Last updated
2019-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiectasis Adult, COPD Asthma, COPD Exacerbation, Humidifier Lung, Lung Infection, Quality of Life

Keywords

Bronchiectasis, High Flow Therapy, Humidifcation, Lung Infection, Quality of life

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

Interventions

DEVICEHigh Flow Humidification

myAirvo2 gives at home for long therapy treatment

Sponsors

Dr. Giuseppe Fiorentino
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Diagnosis of Bronchiectasis on HRCT * Optimization of Therapy for at least 15 days before enrollment * Autonomous patients with possibilities of practicing rehabilitations cycles

Exclusion criteria

* OSAS (ODI\>10/h) * HOME NIV * PH\<7,35 - paO2\< 60mmHg, paCo2\> 55 mmHg * Lung cancer * Contraindication to high-flow nasal cannula (hfnc)

Design outcomes

Primary

MeasureTime frameDescription
number of exacerbations including their durations and severity1 yearcounting form their clinic diary of number of exacerbation
measurement Exercise tolerance1 yearmeasurement with 6 minutes walking test
Number of missed working or school day1 yearCalculation of days of sick
time from first exacerbations1 yearmeasurement of time dalay from last exacerbation
Improvment Daily Life1 yearmeasurement via questionary SGRQ
measurement of Sputum production1 yearMicrobiological Mesurement of sputum

Secondary

MeasureTime frameDescription
Unit of Nitric Oxide1 yearMeasurement with Nitric oxide device
Evaluation of Reactive C-Protein1 yearcomparation of blood draw
Evaluation of Arterial Blood Glass1 yearArterial Blood Glass draw at time zero and time 1

Countries

Italy

Contacts

Primary ContactGiuseppe Fiorentino, Doctor
giuseppefiorentino1@gmail.com+393478482564

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026