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

Universidad San Jorge20 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

INHALATION WITH PEP DEVICE (Acapella Duet)DEVICE

Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Asociación Aragonesa de Fibrosis Quística

Zaragoza, Spain

Outcomes

Primary Outcomes

Wet sputum production

Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)

Time frame: 45 minutes

Secondary Outcomes

Wet sputum production

2 hours wet sputum production (ml) after chest physiotherapy session

Time frame: 2 hours

Wet sputum production

22 hours wet sputum production (ml) after chest physiotherapy session

Time frame: 22 hours

Lung function (simply spirometry)

Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75

Time frame: 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

Time frame: 45 minutes

Patient's perception (Likert test)

Likert test

Time frame: 5 days

Questionnaire

Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C\&S)

Time frame: 5 days

Data from ClinicalTrials.gov

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