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

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02303808
• Other study ID #: FQ_INH_PEP_01
• Secondary ID: 239|2012
• Status: Completed
• Phase: N/A
• First received: November 25, 2014
• Last updated: December 1, 2015
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Device:
• INHALATION WITH PEP DEVICE (Acapella Duet)
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.

Locations

Country	Name	City	State
Spain	Asociación Aragonesa de Fibrosis Quística	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wet sputum production	Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)	45 minutes	No
Secondary	Wet sputum production	2 hours wet sputum production (ml) after chest physiotherapy session	2 hours	No
Secondary	Wet sputum production	22 hours wet sputum production (ml) after chest physiotherapy session	22 hours	No
Secondary	Lung function (simply spirometry)	Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75	5 days	No
Secondary	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	No
Secondary	Patient's perception (Likert test)	Likert test	5 days	No
Secondary	Questionnaire	Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S)	5 days	No