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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

NCT01854788

Bronchiectasis

COMPLETED NA

Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis

NCT02324855

Bronchiectasis

COMPLETED NA

Airway Clearance and Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation

NCT03643302

Bronchiectasis Adult

COMPLETED

ELTGOL and Bronchiectasis. Respiratory Therapy

NCT01578681

Respiratory; Complications, Therapy Bronchiectasis

COMPLETED NA

Airway Clearance Technique of Oscillation and Lung Expansion in Bronchiectasis

NCT06393257

Bronchiectasis Adult

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiectasis Airway Clearance Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A non-inferiority randomized clinical trial (single-blinded assessor).

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

The assessors in charge of the measures will be blind to the group assignment of participants until the study has been completed

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Single daily session (Hypertonic saline + airway clearance techniques)

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.

Group Type EXPERIMENTAL

Hypertonic saline at 6%

Intervention Type 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.

Airway clearance techniques (oscillating positive expiratory pressure therapy)

Intervention Type 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

Twice daily session (Hypertonic saline + airway clearance techniques)

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.

Group Type ACTIVE_COMPARATOR

Hypertonic saline at 6%

Intervention Type 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.

Airway clearance techniques (oscillating positive expiratory pressure therapy)

Intervention Type 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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Hypertonic 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.

Intervention Type OTHER

Airway 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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No