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Completed

NCT Number: NCT02303808

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

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).

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asociación Aragonesa de Fibrosis Quística

Zaragoza, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

INHALATION WITH PEP DEVICE (Acapella Duet)

Device

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

Primary outcomes

  1. Wet sputum production

    Time frame: 45 minutes

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

Secondary outcomes

  1. Wet sputum production

    Time frame: 2 hours

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

  2. Wet sputum production

    Time frame: 22 hours

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

  3. Lung function (simply spirometry)

    Time frame: 5 days

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

  4. Safety and tolerability of session (Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate)

    Time frame: 45 minutes

    Pulse-oximetry, heart rate, dyspnea, hemoptysis, cough, throat irritability and saltiness, heart rate

  5. Patient's perception (Likert test)

    Time frame: 5 days

    Likert test

  6. Questionnaire

    Time frame: 5 days

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

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 1, 2014
Registry last updated
Dec 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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