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

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Other: Isotonic saline solution; Other: Hypertonic saline solution; Other: Hyaneb solution

• Registration Number: NCT02392663
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-13
• Study First Submitted QC: 2015-03-18
• Study First Posted: 2015-03-19
• Primary Completion: 2015-12
• Study Completion: 2016-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-11
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

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

Exclusion Criteria

1. Forced expiratory volume in 1 second < 30% pred. ; Total lung capacity < 45% pred.
2. Performing nebulization with any hyperosmolar agents, previously
3. Allergic bronchopulmonary aspergillosis diagnosis
4. 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Isotonic saline solution	Isotonic saline solution	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.
Hypertonic saline solution	Hypertonic saline solution	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.
Hyaneb solution	Hyaneb solution	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.

Primary Outcome Measures

Name	Time	Method
Wet sputum production	1h wet sputum production (g)	Sputum collected during nebulization period and physiotherapy session

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital Clinic; 🇪🇸 Barcelona, Spain