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NCT Number: NCT02392663

Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis

This study aims to analyze whether the hypertonic saline nebulization enhances sputum clearance effects, reduces the impact on cough severity and their level of safety and tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition, this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinic

Barcelona, 08036, Spain

About this study

The present study will be a randomized, double-blind, crossover trial. Each nebulized solution [hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%)] will be administrated during 4 days. After each inhalation, all patients will carry out a bronchial drainage session (autogenic drainage technique). All patients recruited will perform the three arms of intervention. In this way, each patient will be able to act as his/her own control.

A 7 days washout period will be required among the different solutions to avoid carryover effects.

During the study period the patients' pharmacological treatment remained unchanged.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Non-cystic Fibrosis bronchiectasis (NCFBE) diagnosed by High Resolution Computed Tomographic
  • Mean sputum production ≥ 10 ml /24h.
  • Clinical stability in the last 4 weeks
  • To be able to understand how to perform inhalation and the physiotherapy session.
  • To be able to provide written, informed consent

Exclusion criteria

  • Forced expiratory volume in 1 second < 30% pred. ; Total lung capacity < 45% pred.
  • Performing nebulization with any hyperosmolar agents, previously
  • Allergic bronchopulmonary aspergillosis diagnosis
  • Not to be able to overcome the safety test pre-intervention (oxygen saturation levels drop to < 90% and/or forced expiratory volume in 1 second decline more than < 12% from baseline during the nebulization process)

Treatment and study plan

Hypertonic saline solution

Other

All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.

Hyaneb solution

Other

All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.

Isotonic saline solution

Other

All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.

Primary outcomes

  1. Wet sputum production

    Time frame: 1h wet sputum production (g)

    Sputum collected during nebulization period and physiotherapy session

Secondary outcomes

  1. Wet sputum production

    Time frame: 24h wet sputum production (g)

    Spontaneous sputum expectorated during the following 24h after intervention

  2. Impact on cough severity (Leicester Cough Questionnaire)

    Time frame: One week

    Self-administered questionnaire (Leicester Cough Questionnaire)

  3. Lung function (Forced spirometry)

    Time frame: One week

    Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75

  4. Safety and tolerability (Adverse events)

    Time frame: 20 minutes

    Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)

Other outcomes

  1. Patients´preference (Likert test)

    Time frame: 5 weeks

    Self-administered "Likert test" at the end of the trial

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
Nov 15, 2016

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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