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

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

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

Study Overview

• Status: Unknown
• Conditions: Quality of Life; COPD Exacerbation; Bronchiectasis Adult; Lung Infection; Humidifier Lung; COPD Asthma
• Intervention / Treatment: Device: High Flow Humidification

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Giuseppe Fiorentino, Doctor; Phone Number: +393478482564; Email: giuseppefiorentino1@gmail.com

Study Locations

• Italy
  • Napoli, Italy, 80131
    • Recruiting
    • Rosa Cauteruccio
    • Contact: Rosa Cauteruccio, Doctor; Phone Number: +393392193620; Email: rosacauteruccio@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Therapy with high flow humidification; The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations	Device: High Flow Humidification; myAirvo2 gives at home for long therapy treatment
No Intervention: Therapy with usual care; The patients will be under usual care for observational

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Giuseppe Fiorentino

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2019
• Primary Completion (Anticipated): March 3, 2020
• Study Completion (Anticipated): September 3, 2020

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 25, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 25, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Quality of life; Bronchiectasis; High Flow Therapy; Humidifcation; Lung Infection
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: High Flow in Bronchiectasis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No