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%).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
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.
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.
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.
Hospital Clinic
Barcelona, Barcelona, Spain
Wet sputum production
Sputum collected during nebulization period and physiotherapy session
Time frame: 1h wet sputum production (g)
Wet sputum production
Spontaneous sputum expectorated during the following 24h after intervention
Time frame: 24h wet sputum production (g)
Impact on cough severity (Leicester Cough Questionnaire)
Self-administered questionnaire (Leicester Cough Questionnaire)
Time frame: One week
Lung function (Forced spirometry)
Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75
Time frame: One week
Safety and tolerability (Adverse events)
Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)
Time frame: 20 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.