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

Not Applicable

• Conditions: Lung Infection; Humidifier Lung; COPD Exacerbation; Bronchiectasis Adult; Quality of Life; COPD Asthma
• Interventions: Device: High Flow Humidification

• Registration Number: NCT04142827
• Lead Sponsor: Dr. Giuseppe Fiorentino

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-04
• Status Verified: 2019-10
• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-25
• Last Update Submitted: 2019-10-25
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-03-03
• Study Completion: 2020-09-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Therapy with high flow humidification	High Flow Humidification	The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations

Primary Outcome Measures

Name	Time	Method
time from first exacerbations	1 year	measurement of time dalay from last exacerbation
Improvment Daily Life	1 year	measurement via questionary SGRQ
Number of missed working or school day	1 year	Calculation of days of sick
number of exacerbations including their durations and severity	1 year	counting form their clinic diary of number of exacerbation
measurement Exercise tolerance	1 year	measurement with 6 minutes walking test
measurement of Sputum production	1 year	Microbiological Mesurement of sputum

Secondary Outcome Measures

Name	Time	Method
Evaluation of Arterial Blood Glass	1 year	Arterial Blood Glass draw at time zero and time 1
Unit of Nitric Oxide	1 year	Measurement with Nitric oxide device
Evaluation of Reactive C-Protein	1 year	comparation of blood draw

Trial Locations

Locations (1)

Rosa Cauteruccio; 🇮🇹 Napoli, Italy