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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Expiratory Flow Accelerator | Experimental | Patients for 6 weeks use the Expiratory Flow Accelerator Technology |
|
| Expiratory Flow Accelerator + HIGH FLOW Technology | Experimental | Patients for 6 weeks use the EFA technology and High Flow Technology |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchial Clearance A | Device | EFA technology: the patient has to breathe at tidal volume by a mouthpiece at level 5 for half an hour twice a day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cough Severity | Visual Analogic Scale (0=not severe cough;10=very severe cough) | "Day0", "Week6", Week13" |
| Expectoration Difficulty | Visual Analogic Scale (0=not severe expectoration difficulty;10= very severe expectoration difficulty) | "Day0", "Week6", Week13" |
| Measure | Description | Time Frame |
|---|---|---|
| FEV 1 (Forced Expiratory Volume) | Airway obstruction index measured by spirometry | "Day0", "Week6", Week13" |
| Exacerbations | number of exacerbation/ year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marianna Messina | Contact | +393356509059 | annamessina.mm@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Marianna Messina | ASST Valle Olona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marianna Messina | Recruiting | Somma Lombardo | Varese | 21019 | Italy |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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the two arms of the study are:
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| Bronchial Clearance B | Device | 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. |
|
| "Day0", "Week6", Week13" |
| Inspiratory Capacity | air trapping index measured by spirometry | "Day0", "Week6", Week13" |
| 6 minutes walking test | index of cardiorespiratory function in activities of daily living | "Day0", "Week6", Week13" |
| Saint George Respiratory Questionnaire | quality of life | "Day0", "Week6", Week13" |
| Medical Research Council mMRC | dyspnea perception (0 no dyspnea, 4 very important dyspnea) | "Day0", "Week6", Week13" |
| SpO2 (Oxygen Saturation by Pulse Oximetry) | blood oxygen saturation | "Day0", "Week6", Week13" |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |