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

Hospital Clinic of Barcelona

Status: Completed

Conditions: Bronchiectasis

Treatments: Other: Hyaneb solution; Other: Isotonic saline solution; Other: Hypertonic saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT02392663

Hyperosmolar_NCFB

Details and patient eligibility

About

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%).

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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24 participants in 3 patient groups, including a placebo group

Hypertonic saline solution

Active Comparator group

Description:

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.

Treatment:

Other: Hypertonic saline solution

Hyaneb solution

Active Comparator group

Description:

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.

Treatment:

Other: Hyaneb solution

Isotonic saline solution

Placebo Comparator group

Description:

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.

Treatment:

Other: Isotonic saline solution