Clinical trial NCT04905992: Is a Single Daily Session Combining HS + Physio Sufficient to Obtain Long-term Clinical Benefits in Bronchiectasis?
Official title: Is a Single Daily Session Combining Hypertonic Saline Nebulisation and Airway Clearance Techniques Sufficient to Obtain Long-term Clinical Benefits in People With Bronchiectasis? A Randomised Non-inferiority Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchiectasis
Airway Clearance Impairment
Keywords: Airway clearance techniques
Hypertonic saline
Hyperosmolar agents
Oscillating positive expiratory pressure
Lead sponsor: Hospital Clínico Universitario Lozano Blesa
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Universidad San Jorge
First posted: 2021-05-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A non-inferiority randomized clinical trial (single-blinded assessor).
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Impact of coughing on quality of life
timeFrame: 6 months after starting the intervention
Secondary outcomes:
measure: Impact of coughing on quality of life
timeFrame: Baseline point, 1 month and 3 months after starting the intervention
measure: Disease-specific quality of life questionnaire
timeFrame: Baseline point, 1 month, 3 months and 6 months after starting the intervention
measure: Disease-specific symptoms questionnaire
timeFrame: Baseline point, 1 month, 3 months and 6 months after starting the intervention
measure: Exercise capacity
timeFrame: Baseline point, 1 month, 3 months and 6 months after starting the intervention
measure: Exercise capacity
timeFrame: Baseline point
measure: Exacerbations
timeFrame: From baseline point to the end of the intervention (6 months)
measure: Biophysical properties of spontaneous sputum samples
timeFrame: Baseline point, 1 month, 3 months, 6 months
measure: Inflammation markers (airway inflammation and systemic inflammation)
timeFrame: Baseline point, 1 month, 3 months, 6 months
Other outcomes:
measure: Lung Function
timeFrame: Baseline point, 1 month, 3 months, 6 months
measure: Adverse events during sessions
timeFrame: Baseline point, 1 month, 3 months, 6 months
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Zaragoza
country: Spain
facility: Beatriz Herrero Cortina
Study officials:
affiliation: Hospital Clinic of Barcelona
name: Victoria Alcaraz-Serrano
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Lozano Blesa
name: Beatriz Herrero-Cortina
role: PRINCIPAL_INVESTIGATOR
References: