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

Bronchiectasis Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04905992
• Other study ID #: HS_nonInferiority
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: December 2023

Study information

• Verified date: June 2021
• Source: Hospital Clínico Universitario Lozano Blesa
• Contact: Beatriz Herrero-Cortina
• Phone: 34653051357
• Email: Beafisiorespi[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 2023
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Airway Clearance Impairment
• Bronchiectasis

Intervention

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.
• 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

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona
Spain	Beatriz Herrero Cortina	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Clínico Universitario Lozano Blesa	Hospital Clinic of Barcelona, Universidad San Jorge

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Function	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	Baseline point, 1 month, 3 months, 6 months
Other	Adverse events during sessions	Adverse events during nebulisation period will be recorded using a Likert scale and participants will also complete the Self-Reported Medication Scale	Baseline point, 1 month, 3 months, 6 months
Primary	Impact of coughing on quality of life	The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact	6 months after starting the intervention
Secondary	Impact of coughing on quality of life	The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact	Baseline point, 1 month and 3 months after starting the intervention
Secondary	Disease-specific quality of life questionnaire	The Quality of life of Bronchiectasis (QoL-B) questionnaire will be used to evaluate the quality of life	Baseline point, 1 month, 3 months and 6 months after starting the intervention
Secondary	Disease-specific symptoms questionnaire	The Bronchiectasis Impact Measure (BIM) outcome measure will be used to analyse the symptoms	Baseline point, 1 month, 3 months and 6 months after starting the intervention
Secondary	Exercise capacity	The sit to stand test (1 minute) will be used to assess the exercise capacity	Baseline point, 1 month, 3 months and 6 months after starting the intervention
Secondary	Exercise capacity	The six minute walk distance (6MWT) will be used to assess the exercise capacity	Baseline point
Secondary	Exacerbations	The number of exacerbations, the severity of exacerbations (hospital admission) and the time to the first exacerbation will be recorded prospectively	From baseline point to the end of the intervention (6 months)
Secondary	Biophysical properties of spontaneous sputum samples	Spontaneous sputum samples will be collected to analyse the main biophysical markers	Baseline point, 1 month, 3 months, 6 months
Secondary	Inflammation markers (airway inflammation and systemic inflammation)	Blood and salivary samples will be collected to analyse the main inflammatory markers (neutrophil elastase, cytokines, peptides)	Baseline point, 1 month, 3 months, 6 months