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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypertonic saline solution | Active Comparator | 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. |
|
| Hyaneb solution | Active Comparator | 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. |
|
| Isotonic saline solution | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline solution | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wet sputum production | Sputum collected during nebulization period and physiotherapy session | 1h wet sputum production (g) |
| Measure | Description | Time Frame |
|---|---|---|
| Wet sputum production | Spontaneous sputum expectorated during the following 24h after intervention | 24h wet sputum production (g) |
| Impact on cough severity (Leicester Cough Questionnaire) | Self-administered questionnaire (Leicester Cough Questionnaire) |
| Measure | Description | Time Frame |
|---|---|---|
| Patients´preference (Likert test) | Self-administered "Likert test" at the end of the trial | 5 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eva Polverino, Dr. | Hospital Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | Barcelona | 08036 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32071136 | Derived | 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. |
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| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Hyaneb solution | Other | 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. |
|
| Isotonic saline solution | Other | 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. |
|
| One week |
| Lung function (Forced spirometry) | Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75 | One week |
| Safety and tolerability (Adverse events) | Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea) | 20 minutes |