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

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Brief Title

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.

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.
    


Study Type

Interventional


Primary Outcome

Impact of coughing on quality of life

Secondary Outcome

 Impact of coughing on quality of life

Condition

Bronchiectasis

Intervention

Hypertonic saline at 6%

Study Arms / Comparison Groups

 Single daily session (Hypertonic saline + airway clearance techniques)
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

50

Start Date

July 1, 2021

Completion Date

December 2023

Primary Completion Date

June 2023

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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Victoria Alcaraz-Serrano, 34653051357, [email protected]

Location Countries

Spain

Location Countries

Spain

Administrative Informations


NCT ID

NCT04905992

Organization ID

HS_nonInferiority


Responsible Party

Principal Investigator

Study Sponsor

Hospital Clínico Universitario Lozano Blesa

Collaborators

 Hospital Clinic of Barcelona

Study Sponsor

Victoria Alcaraz-Serrano, Principal Investigator, Hospital Clinic of Barcelona


Verification Date

June 2021