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

Quality of Life Clinical Trial

— BX  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04142827
• Other study ID #: High Flow in Bronchiectasis
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2019
• Est. completion date: September 3, 2020

Study information

• Verified date: October 2019
• Source: Monaldi Hospital
• Contact: Giuseppe Fiorentino, Doctor
• Phone: +393478482564
• Email: giuseppefiorentino1[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: September 3, 2020
• Est. primary completion date: March 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Device:
• High Flow Humidification
myAirvo2 gives at home for long therapy treatment

Locations

Country	Name	City	State
Italy	Rosa Cauteruccio	Napoli

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Giuseppe Fiorentino

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvment Daily Life	measurement via questionary SGRQ	1 year
Primary	measurement of Sputum production	Microbiological Mesurement of sputum	1 year
Primary	measurement Exercise tolerance	measurement with 6 minutes walking test	1 year
Primary	Number of missed working or school day	Calculation of days of sick	1 year
Primary	time from first exacerbations	measurement of time dalay from last exacerbation	1 year
Primary	number of exacerbations including their durations and severity	counting form their clinic diary of number of exacerbation	1 year
Secondary	Evaluation of Arterial Blood Glass	Arterial Blood Glass draw at time zero and time 1	1 year
Secondary	Unit of Nitric Oxide	Measurement with Nitric oxide device	1 year
Secondary	Evaluation of Reactive C-Protein	comparation of blood draw	1 year