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

Primary Purpose

Bronchiectasis Adult, Lung Infection, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
High Flow Humidification
Sponsored by
Dr. Giuseppe Fiorentino
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis Adult focused on measuring Bronchiectasis, High Flow Therapy, Humidifcation, Lung Infection, Quality of life

Eligibility Criteria

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

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)

Sites / Locations

  • Rosa CauteruccioRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Therapy with high flow humidification

Therapy with usual care

Arm Description

The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations

The patients will be under usual care for observational

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2019
Last Updated
October 25, 2019
Sponsor
Dr. Giuseppe Fiorentino
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1. Study Identification

Unique Protocol Identification Number
NCT04142827
Brief Title
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)
Acronym
BX
Official Title
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2019 (Actual)
Primary Completion Date
March 3, 2020 (Anticipated)
Study Completion Date
September 3, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Giuseppe Fiorentino

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis Adult, Lung Infection, Quality of Life, Humidifier Lung, COPD Exacerbation, COPD Asthma
Keywords
Bronchiectasis, High Flow Therapy, Humidifcation, Lung Infection, Quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Therapy with high flow humidification
Arm Type
Experimental
Arm Description
The patients will be activated after enrollment with myAirvo2 device at home for 6 months before first observations
Arm Title
Therapy with usual care
Arm Type
No Intervention
Arm Description
The patients will be under usual care for observational
Intervention Type
Device
Intervention Name(s)
High Flow Humidification
Intervention Description
myAirvo2 gives at home for long therapy treatment
Primary Outcome Measure Information:
Title
Improvment Daily Life
Description
measurement via questionary SGRQ
Time Frame
1 year
Title
measurement of Sputum production
Description
Microbiological Mesurement of sputum
Time Frame
1 year
Title
measurement Exercise tolerance
Description
measurement with 6 minutes walking test
Time Frame
1 year
Title
Number of missed working or school day
Description
Calculation of days of sick
Time Frame
1 year
Title
time from first exacerbations
Description
measurement of time dalay from last exacerbation
Time Frame
1 year
Title
number of exacerbations including their durations and severity
Description
counting form their clinic diary of number of exacerbation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Evaluation of Arterial Blood Glass
Description
Arterial Blood Glass draw at time zero and time 1
Time Frame
1 year
Title
Unit of Nitric Oxide
Description
Measurement with Nitric oxide device
Time Frame
1 year
Title
Evaluation of Reactive C-Protein
Description
comparation of blood draw
Time Frame
1 year

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Fiorentino, Doctor
Phone
+393478482564
Email
giuseppefiorentino1@gmail.com
Facility Information:
Facility Name
Rosa Cauteruccio
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rosa Cauteruccio, Doctor
Phone
+393392193620
Email
rosacauteruccio@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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