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

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Device: INHALATION WITH PEP DEVICE (Acapella Duet)

• Registration Number: NCT02303808
• Lead Sponsor: Universidad San Jorge

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-11-25
• Study First Submitted QC: 2014-11-28
• Study Start: 2014-12
• Study First Posted: 2014-12-01
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
INHALATION WITH PEP DEVICE	INHALATION WITH PEP DEVICE (Acapella Duet)	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.

Primary Outcome Measures

Name	Time	Method
Wet sputum production	45 minutes	Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asociación Aragonesa de Fibrosis Quística; 🇪🇸 Zaragoza, Spain