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

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

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).

Study Overview

• Status: Completed
• Conditions: Cystic Fibrosis
• Intervention / Treatment: Device: INHALATION WITH PEP DEVICE (Acapella Duet)

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 Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Zaragoza, Spain
    • Asociación Aragonesa de Fibrosis Quística

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: USUAL CARE; 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; 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); Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Investigators: Principal Investigator: Marta San Miguel, Universidad San Jorge

Publications and helpful links

General Publications

• San Miguel-Pagola M, Reychler G, Cebria I Iranzo MA, Gomez-Romero M, Diaz-Gutierrez F, Herrero-Cortina B. Impact of hypertonic saline nebulisation combined with oscillatory positive expiratory pressure on sputum expectoration and related symptoms in cystic fibrosis: a randomised crossover trial. Physiotherapy. 2020 Jun;107:243-251. doi: 10.1016/j.physio.2019.11.001. Epub 2019 Nov 11.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: November 25, 2014
• First Submitted That Met QC Criteria: November 28, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): December 2, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Positive Expiratory Pressure; Hypertonic saline; Hyperosmolar agents; Airway clearance techniques; Autogenic drainage
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Cystic Fibrosis
• Other Study ID Numbers: FQ_INH_PEP_01; 239|2012 (Other Grant/Funding Number: SEPAR)