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

Study Overview
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Brief Summary
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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%).

Detailed Description
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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.

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

Conditions
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Bronchiectasis

Intervention / Treatment
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* Other: Hypertonic saline solution
* Other: Hyaneb solution
* Other: Isotonic saline solution


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hypertonic saline solution<br>Hypertonic saline (7%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD). Both patients and physiotherapist will be blind to the intervention. | Other: Hypertonic saline solution<br>* 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.<br>|
| Active Comparator: Hyaneb solution<br>Hyaneb (acid hyaluronic + hypertonic saline [7%]) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD). Both patients and physiotherapist will be blind to the intervention. | Other: Hyaneb solution<br>* 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.<br>|
| Placebo Comparator: Isotonic saline solution<br>Isotonic saline (0,9%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD). Both patients and physiotherapist will be blind to the intervention. | Other: Isotonic saline solution<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet sputum production | Sputum collected during nebulization period and physiotherapy session | 1h wet sputum production (g) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wet sputum production | Spontaneous sputum expectorated during the following 24h after intervention | 24h wet sputum production (g) | 
| Impact on cough severity (Leicester Cough Questionnaire) | Self-administered questionnaire (Leicester Cough Questionnaire) | One week | 
| Lung function (Forced spirometry) | Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75 | One week | 
| Safety and tolerability (Adverse events) | Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea) | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sputum clearance, Cough severity, Hypertonic saline, Acid hyaluronic, Tolerability