Bronchiectasis Clinical Trial
Official title:
Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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