Back to resultsPositive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
INHALATION WITH PEP DEVICE (Acapella Duet)
Sponsored by
About this trial
This is an interventional treatment trial for Cystic Fibrosis focused on measuring Hyperosmolar agents, Hypertonic saline, Airway clearance techniques, Positive Expiratory Pressure, Autogenic drainage
Eligibility Criteria
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
Sites / Locations
- Asociación Aragonesa de Fibrosis Quística
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
USUAL CARE
INHALATION WITH PEP DEVICE
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Wet sputum production
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
Secondary Outcome Measures
Wet sputum production
2 hours wet sputum production (ml) after chest physiotherapy session
Wet sputum production
22 hours wet sputum production (ml) after chest physiotherapy session
Lung function (simply spirometry)
Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
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
Patient's perception (Likert test)
Likert test
Questionnaire
Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S)
Full Information
NCT ID
NCT02303808
First Posted
November 25, 2014
Last Updated
December 1, 2015
Sponsor
Universidad San Jorge
1. Study Identification
Unique Protocol Identification Number
NCT02303808
Brief Title
Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis
Official Title
Effect of Introducing a Positive Expiratory Pressure Device During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis: a Randomized Crossover Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Hyperosmolar agents, Hypertonic saline, Airway clearance techniques, Positive Expiratory Pressure, Autogenic drainage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
USUAL CARE
Arm Type
No Intervention
Arm Description
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.
Arm Title
INHALATION WITH PEP DEVICE
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
INHALATION WITH PEP DEVICE (Acapella Duet)
Intervention Description
Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
Primary Outcome Measure Information:
Title
Wet sputum production
Description
Wet sputum production (ml) during chest physiotherapy session (inhalation + bronchial drainage)
Time Frame
45 minutes
Secondary Outcome Measure Information:
Title
Wet sputum production
Description
2 hours wet sputum production (ml) after chest physiotherapy session
Time Frame
2 hours
Title
Wet sputum production
Description
22 hours wet sputum production (ml) after chest physiotherapy session
Time Frame
22 hours
Title
Lung function (simply spirometry)
Description
Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Time Frame
5 days
Title
Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)
Description
Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate
Time Frame
45 minutes
Title
Patient's perception (Likert test)
Description
Likert test
Time Frame
5 days
Title
Questionnaire
Description
Leicester Cough Questionnaire (LCQ) and Cough and sputum Questionnaire (C&S)
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marta San Miguel
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asociación Aragonesa de Fibrosis Quística
City
Zaragoza
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
32026826
Citation
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.
Results Reference
derived
Learn more about this trial
Positive Expiratory Pressure During Inhalation of Hypertonic Saline in Patients With Cystic Fibrosis
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