Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis

Study Overview
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Brief Summary
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This trial aims to analyze whether the inhalation of hypertonic saline combined with a positive expiratory pressure (PEP) device increases the amount of sputum expectorated during the chest physiotherapy session ( inhalation + bronchial drainage).

Detailed Description
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All patients will perform two different arms of treatment in a crossover randomization. Each arm of treatment will be applied during 5 consecutive days. The wash-out period will be one week. Before starting the trial all patients will do an inhalation formation. During the study period the patients' pharmacological treatment remains unchanged

Official Title
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Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Device: INHALATION WITH PEP DEVICE (Acapella Duet)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pass the inhalation test Chronic sputum production, at least ≥ 10 ml /24h Cystic Fibrosis (CF) diagnosed ( established by genotype or sweat sodium>70 mmol/l or sweat chloride of>60 mmol/l) Clinically stable at the time of recruitment (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 weeks) Trained in the use of autogenic drainage technique (at least 6 months) Inhaling hypertonic saline since at least 6 months To be able to provide written, informed consent and perform the protocol and the evaluations Exclusion Criteria: Active massive hemoptysis during the previous 2 months Patient in transplantation or retransplantation list Patient already participating in another study at the same time

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: USUAL CARE<br>Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. | |
| Active Comparator: INHALATION WITH PEP DEVICE<br>Patients will perform the inhalation of the 7% hypertonic saline (following the gold standard recomendation) combined with a PEP device (Acapella Duet) during 15 minutes. Right after, patients will perform independently their usual session of autogenic drainage during 30 minutes. | Device: INHALATION WITH PEP DEVICE (Acapella Duet)<br>* Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet sputum production | Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage) | 45 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet sputum production | 2 hours wet sputum production (ml) after chest physiotherapy session | 2 hours | 
| Wet sputum production | 22 hours wet sputum production (ml) after chest physiotherapy session | 22 hours | 
| Lung function (simply spirometry) | Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 | 5 days | 
| Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate) | Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate | 45 minutes | 
| Patient's perception (Likert test) | Likert test | 5 days | 
| Questionnaire | Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S) | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperosmolar agents, Hypertonic saline, Airway clearance techniques, Positive Expiratory Pressure, Autogenic drainage