Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hospital Clinic of Barcelona | OTHER |
| Universidad San Jorge | OTHER |
Not provided
Not provided
Not provided
Not provided
The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic saline (HS) at 6% followed by airway clearance techniques) is at least as effective as performing two sessions per day following the same process in each of the sessions, during a period of 6 months.
A non-inferiority randomised clinical trial (single-blind) will be conducted. At least 50 participants will be recruited from the outpatient clinics of the Hospital Clinic in Barcelona and the Clinical University Hospital in Zaragoza. The experimental group will nebulize once/day the hypertonic saline (HS) solution followed by airway clearance exercises (15 min) for 6 months. The control group will follow the same procedure, but the frequency of the sessions will be twice a day (reference as usual clinical practice). The main study outcomes will be: (1) cough severity (primary endpoint), symptoms and quality of life; (2) functional exercise capacity; (3) time to first exacerbation and total number of exacerbations; (4) indirect measures of mucociliary transport (rheology and concentration of solids in sputum samples); (5) inflammatory parameters; (5) tolerance, safety and adherence to treatment. Measurements will be taken at baseline (prior to randomization), at 1 month, 3 months, and 6 months. Finally, hypothesis testing will be performed using a linear mixed model (2x3) of repeated measures, establishing a priori a margin of non-inferiority.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single daily session (Hypertonic saline + airway clearance techniques) | Experimental | The experimental group will perform a daily session at home including nebulisation of 5 mL of hypertonic saline (at 6%) followed by 15 min of airway clearance techniques (oscillating positive expiratory pressure therapy) for 6 months. |
|
| Twice daily session (Hypertonic saline + airway clearance techniques) | Active Comparator | The control group will perform two daily sessions at home involving nebulisation of 5 mL of hypertonic saline (at 6%) followed by 15 min of airway clearance techniques (oscillating positive expiratory pressure therapy) for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline at 6% | Other | Participants will start the sessions by inhaling a short-acting bronchodilator or an anticholinergic to avoid the presence of bronchospasm during nebulisation. The hypertonic solution (at 6%) will be administered through the Turbo Boy nebuliser (Pari®). The intervention will take place at home. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of coughing on quality of life | The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact | 6 months after starting the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of coughing on quality of life | The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact | Baseline point, 1 month and 3 months after starting the intervention |
| Disease-specific quality of life questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Function | Forced spirometry (forced expiratory volume in 1 second [FEV1] and forced vital capacity [FVC]) will be perform for safety analysis following the American Thoracic Society / European Respiratory Society guidelines | Baseline point, 1 month, 3 months, 6 months |
| Adverse events during sessions |
Inclusion Criteria:
In addition, all participants will have had to satisfactorily pass the tolerability tests, which will be performed twice: i) on the first day; ii) and the following week.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Beatriz Herrero-Cortina | Contact | 34653051357 | Beafisiorespi@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Victoria Alcaraz-Serrano | Hospital Clinic of Barcelona | Principal Investigator |
| Beatriz Herrero-Cortina | Hospital ClÃnico Universitario Lozano Blesa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic | Barcelona | Spain | ||||
| Beatriz Herrero Cortina |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
A non-inferiority randomized clinical trial (single-blinded assessor).
Not provided
Not provided
The assessors in charge of the measures will be blind to the group assignment of participants until the study has been completed
|
| Airway clearance techniques (oscillating positive expiratory pressure therapy) | Other | Following nebulisation, participants will perform airway clearance techniques using an oscillating positive expiratory pressure device for at least 15 minutes. The intervention will take place at home |
|
The Quality of life of Bronchiectasis (QoL-B) questionnaire will be used to evaluate the quality of life
| Baseline point, 1 month, 3 months and 6 months after starting the intervention |
| Disease-specific symptoms questionnaire | The Bronchiectasis Impact Measure (BIM) outcome measure will be used to analyse the symptoms | Baseline point, 1 month, 3 months and 6 months after starting the intervention |
| Exercise capacity | The sit to stand test (1 minute) will be used to assess the exercise capacity | Baseline point, 1 month, 3 months and 6 months after starting the intervention |
| Exercise capacity | The six minute walk distance (6MWT) will be used to assess the exercise capacity | Baseline point |
| Exacerbations | The number of exacerbations, the severity of exacerbations (hospital admission) and the time to the first exacerbation will be recorded prospectively | From baseline point to the end of the intervention (6 months) |
| Biophysical properties of spontaneous sputum samples | Spontaneous sputum samples will be collected to analyse the main biophysical markers | Baseline point, 1 month, 3 months, 6 months |
| Inflammation markers (airway inflammation and systemic inflammation) | Blood and salivary samples will be collected to analyse the main inflammatory markers (neutrophil elastase, cytokines, peptides) | Baseline point, 1 month, 3 months, 6 months |
Adverse events during nebulisation period will be recorded using a Likert scale and participants will also complete the Self-Reported Medication Scale |
| Baseline point, 1 month, 3 months, 6 months |
| Zaragoza |
| Spain |
|
| ID | Term |
|---|---|
| D001987 | Bronchiectasis |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided