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

Sponsor

Hospital Clínico Universitario Lozano Blesa (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04905992

Collaborator

Hospital Clinic of Barcelona (Other), Universidad San Jorge (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiectasis Airway Clearance Impairment	Other: Hypertonic saline at 6% Other: Airway clearance techniques (oscillating positive expiratory pressure therapy)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

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

Primary Purpose:

Treatment

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.

Anticipated Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Other: 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. 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
Active Comparator: 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.	Other: 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. 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

Arm

Intervention/Treatment

Experimental: 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.

Other: 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.

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

Active Comparator: 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.

Other: Hypertonic saline at 6%

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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
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
Exercise capacity [Baseline point]
The six minute walk distance (6MWT) will be used to assess the exercise capacity
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
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)

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years or older
a total score less than 16 on the Leicester Cough Questionnaire
chronic daily expectoration over at least 3 months
being in a period of clinical stability during the previous 4 weeks
presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or >1 L
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:

having received nebulised mucoactive treatment during the previous year
frequent haemoptysis (≥ 2 times/month)
diagnosis or suspicion of cystic fibrosis by genetic study or sweat test
being under active treatment for nontuberculous mycobacteria (NTM)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Clinic	Barcelona		Spain
2	Beatriz Herrero Cortina	Zaragoza		Spain

Sponsors and Collaborators

Hospital Clínico Universitario Lozano Blesa
Hospital Clinic of Barcelona
Universidad San Jorge

Investigators

Principal Investigator: Victoria Alcaraz-Serrano, Hospital Clinic of Barcelona
Principal Investigator: Beatriz Herrero-Cortina, Hospital Clínico Universitario Lozano Blesa