Clinical trial NCT02392663: Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis
Official title: Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Sputum clearance
Cough severity
Hypertonic saline
Acid hyaluronic
Tolerability
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Wet sputum production
timeFrame: 1h wet sputum production (g)
Secondary outcomes:
measure: Wet sputum production
timeFrame: 24h wet sputum production (g)
measure: Impact on cough severity (Leicester Cough Questionnaire)
timeFrame: One week
measure: Lung function (Forced spirometry)
timeFrame: One week
measure: Safety and tolerability (Adverse events)
timeFrame: 20 minutes
Other outcomes:
measure: Patients´preference (Likert test)
timeFrame: 5 weeks
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
affiliation: Hospital Clinic
name: Eva Polverino, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.