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

NCT ID: NCT04142827

Last Updated: 2019-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-04

Study Completion Date

2020-09-03

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Therapy with high flow humidification

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

Group Type EXPERIMENTAL

High Flow Humidification

Intervention Type DEVICE

myAirvo2 gives at home for long therapy treatment

Therapy with usual care

The patients will be under usual care for observational

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High Flow Humidification

myAirvo2 gives at home for long therapy treatment

Intervention Type DEVICE

Eligibility Criteria

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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)
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr. Giuseppe Fiorentino

OTHER

Sponsor Role lead

Responsible Party

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Dr. Giuseppe Fiorentino

Director Giuseppe Fiorentino

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rosa Cauteruccio

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Fiorentino, Doctor

Role: CONTACT

+393478482564

Facility Contacts

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Rosa Cauteruccio, Doctor

Role: primary

+393392193620

Other Identifiers

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High Flow in Bronchiectasis

Identifier Type: -

Identifier Source: org_study_id

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