Bronchiectasis Adult, Copd
Conditions
Keywords
EFA, HIGH FLOW, BRONCHIECTASIS, COPD, HYPERSECRETION
Brief summary
The aim of the study is to compare the efficacy of using EFA technology versus the combination of EFA + high flow in hypersecretory patients COPD and bronchiectasis
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo a 13-weeks trial period: 6 weeks of one technology (EFA / EFA+ HIGH FLOW), 1- wash out week and 6- weeks of the other technology in a cross over randomized trial.
Interventions
DEVICEBronchial Clearance A
EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day.
DEVICEBronchial Clearance B
High Flow Technology: patient has to wear nasal cannula and breathe his nose for one hour twice a day. After he has to use EFA technology level 5 for half an hour twice a day.
Sponsors
Azienda Socio Sanitaria Territoriale della Valle Olona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
the two arms of the study are: 1. EFA / EFA + High Flow 2. EFA + High Flow / EFA patients are randomly assigned to one of two groups
Eligibility
Sex/Gender
ALL
Age
18 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* COPD diagnosed by spirometry * Bronchiectasis diagnosed by CT * 2 Exacerbation/year
Exclusion criteria
* Cystic Fibrosis * OSAS * Non Invasive Ventilation * Ineffective Cough * Exacerbation in progress * Hemodynamic Instability * severe heart failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cough Severity | Day0, Week6, Week13 | Visual Analogic Scale (0=not severe cough;10=very severe cough) |
| Expectoration Difficulty | Day0, Week6, Week13 | Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inspiratory Capacity | Day0, Week6, Week13 | air trapping index measured by spirometry |
| 6 minutes walking test | Day0, Week6, Week13 | index of cardiorespiratory function in activities of daily living |
| FEV 1 (Forced Expiratory Volume) | Day0, Week6, Week13 | Airway obstruction index measured by spirometry |
| Medical Research Council mMRC | Day0, Week6, Week13 | dyspnea perception (0 no dyspnea, 4 very important dyspnea) |
| SpO2 (Oxygen Saturation by Pulse Oximetry) | Day0, Week6, Week13 | blood oxygen saturation |
| Saint George Respiratory Questionnaire | Day0, Week6, Week13 | quality of life |
| Exacerbations | Day0, Week6, Week13 | number of exacerbation/ year |
Countries
Italy
Contacts
Primary ContactMarianna Messina
Outcome results
None listed