Clincosm LogoSign in Get a demo

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

Sponsor
Dr. Giuseppe Fiorentino (Other)
Overall Status
Unknown status
CT.gov ID
NCT04142827
Collaborator
(none)
160
Enrollment
1
Location
2
Arms
12
Anticipated Duration (Months)
13.3
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Device: High Flow Humidification
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care
Actual Study Start Date :
Sep 4, 2019
Anticipated Primary Completion Date :
Mar 3, 2020
Anticipated Study Completion Date :
Sep 3, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Improvment Daily Life [1 year]

    measurement via questionary SGRQ

  2. measurement of Sputum production [1 year]

    Microbiological Mesurement of sputum

  3. measurement Exercise tolerance [1 year]

    measurement with 6 minutes walking test

  4. Number of missed working or school day [1 year]

    Calculation of days of sick

  5. time from first exacerbations [1 year]

    measurement of time dalay from last exacerbation

  6. number of exacerbations including their durations and severity [1 year]

    counting form their clinic diary of number of exacerbation

Secondary Outcome Measures

  1. Evaluation of Arterial Blood Glass [1 year]

    Arterial Blood Glass draw at time zero and time 1

  2. Unit of Nitric Oxide [1 year]

    Measurement with Nitric oxide device

  3. Evaluation of Reactive C-Protein [1 year]

    comparation of blood draw

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Rosa Cauteruccio Napoli Italy 80131

Sponsors and Collaborators

  • Dr. Giuseppe Fiorentino

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Dr. Giuseppe Fiorentino, Director Giuseppe Fiorentino, Monaldi Hospital
ClinicalTrials.gov Identifier:
NCT04142827
Other Study ID Numbers:
  • High Flow in Bronchiectasis
First Posted:
Oct 29, 2019
Last Update Posted:
Oct 29, 2019
Last Verified:
Oct 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr. Giuseppe Fiorentino, Director Giuseppe Fiorentino, Monaldi Hospital
Bronchiectasis
High Flow Therapy
Humidifcation
Lung Infection
Quality of life
Additional relevant MeSH terms:
Bronchiectasis

Study Results

No Results Posted as of Oct 29, 2019