Airway Clearance Impairment, Bronchiectasis
Conditions
Keywords
Airway clearance techniques, Hypertonic saline, Hyperosmolar agents, Oscillating positive expiratory pressure
Brief summary
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.
Detailed description
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.
Interventions
OTHERHypertonic saline at 6%
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.
OTHERAirway clearance techniques (oscillating positive expiratory pressure therapy)
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
Sponsors
Hospital Clinic of Barcelona
Universidad San Jorge
Hospital Clínico Universitario Lozano Blesa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The assessors in charge of the measures will be blind to the group assignment of participants until the study has been completed
Intervention model description
A non-inferiority randomized clinical trial (single-blinded assessor).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years or older 2. a total score less than 16 on the Leicester Cough Questionnaire 3. chronic daily expectoration over at least 3 months 4. being in a period of clinical stability during the previous 4 weeks 5. presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or \>1 L 6. obtaining informed consent. 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
1. having received nebulised mucoactive treatment during the previous year 2. frequent haemoptysis (≥ 2 times/month) 3. diagnosis or suspicion of cystic fibrosis by genetic study or sweat test 4. being under active treatment for nontuberculous mycobacteria (NTM)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of coughing on quality of life | 6 months after starting the intervention | The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise capacity | Baseline point, 1 month, 3 months and 6 months after starting the intervention | The sit to stand test (1 minute) will be used to assess the exercise capacity |
| Impact of coughing on quality of life | Baseline point, 1 month and 3 months after starting the intervention | The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact |
| Disease-specific quality of life questionnaire | Baseline point, 1 month, 3 months and 6 months after starting the intervention | The Quality of life of Bronchiectasis (QoL-B) questionnaire will be used to evaluate the quality of life |
| Disease-specific symptoms questionnaire | Baseline point, 1 month, 3 months and 6 months after starting the intervention | The Bronchiectasis Impact Measure (BIM) outcome measure will be used to analyse the symptoms |
| Biophysical properties of spontaneous sputum samples | Baseline point, 1 month, 3 months, 6 months | Spontaneous sputum samples will be collected to analyse the main biophysical markers |
| Inflammation markers (airway inflammation and systemic inflammation) | Baseline point, 1 month, 3 months, 6 months | Blood and salivary samples will be collected to analyse the main inflammatory markers (neutrophil elastase, cytokines, peptides) |
| Exacerbations | From baseline point to the end of the intervention (6 months) | The number of exacerbations, the severity of exacerbations (hospital admission) and the time to the first exacerbation will be recorded prospectively |
Other
| Measure | Time frame | Description |
|---|---|---|
| Lung Function | Baseline point, 1 month, 3 months, 6 months | 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 |
| Adverse events during sessions | 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 |
Countries
Spain
Contacts
Primary ContactBeatriz Herrero-Cortina
Outcome results
None listed