Bronchiectasis
Conditions
Keywords
Sputum clearance, Cough severity, Hypertonic saline, Acid hyaluronic, Tolerability
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.
Interventions
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.
OTHERHyaneb solution
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.
Sponsors
Hospital Clinic of Barcelona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wet sputum production | 1h wet sputum production (g) | Sputum collected during nebulization period and physiotherapy session |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wet sputum production | 24h wet sputum production (g) | Spontaneous sputum expectorated during the following 24h after intervention |
| Impact on cough severity (Leicester Cough Questionnaire) | One week | Self-administered questionnaire (Leicester Cough Questionnaire) |
| 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) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patients´preference (Likert test) | 5 weeks | Self-administered Likert test at the end of the trial |
Countries
Spain
Outcome results
None listed