Is a Single Daily Session Combining HS + Physio Sufficient to Obtain Long-term Clinical Benefits in Bronchiectasis?

Hospital Clínico Universitario Lozano Blesa

Status: Unknown

Conditions: Bronchiectasis; Airway Clearance Impairment

Treatments: Other: Hypertonic saline at 6%; Other: Airway clearance techniques (oscillating positive expiratory pressure therapy)

Study type: Interventional

Funder types: Other

Identifiers

NCT04905992

HS_nonInferiority

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Single daily session (Hypertonic saline + airway clearance techniques)

Experimental group

Description:

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.

Treatment:

Other: Hypertonic saline at 6%

Other: Airway clearance techniques (oscillating positive expiratory pressure therapy)

Twice daily session (Hypertonic saline + airway clearance techniques)

Active Comparator group

Description:

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.

Treatment:

Other: Hypertonic saline at 6%

Other: Airway clearance techniques (oscillating positive expiratory pressure therapy)