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

NCT04905992 | Unknown DMC

• 1 other identifier: HS_nonInferiority
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Bronchiectasis; Airway Clearance Impairment

Keywords

Airway clearance techniques; Hypertonic saline; Hyperosmolar agents; Oscillating positive expiratory pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Impact of coughing on quality of life

  Baseline point, 1 month and 3 months after starting the intervention

• Disease-specific quality of life questionnaire

  Baseline point, 1 month, 3 months and 6 months after starting the intervention

• Disease-specific symptoms questionnaire

  Baseline point, 1 month, 3 months and 6 months after starting the intervention

• Exercise capacity

  Baseline point, 1 month, 3 months and 6 months after starting the intervention

• Exercise capacity

  Baseline point

Other Outcomes (2)

• Lung Function

  Baseline point, 1 month, 3 months, 6 months

• Adverse events during sessions

  Baseline point, 1 month, 3 months, 6 months

Study Arms (2)

Single daily session (Hypertonic saline + airway clearance techniques)

EXPERIMENTAL

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

Twice daily session (Hypertonic saline + airway clearance techniques)

ACTIVE COMPARATOR

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)

Interventions

Hypertonic saline at 6% 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.

Single daily session (Hypertonic saline + airway clearance techniques); Twice daily session (Hypertonic saline + airway clearance techniques)

Airway clearance techniques (oscillating positive expiratory pressure therapy) 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

Single daily session (Hypertonic saline + airway clearance techniques); Twice daily session (Hypertonic saline + airway clearance techniques)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Clínico Universitario Lozano Blesa: lead
• Hospital Clinic of Barcelona: collaborator
• Universidad San Jorge: collaborator

Study Sites (2)

Hospital Clinic

Barcelona, Spain

Location

Beatriz Herrero Cortina

Zaragoza, Spain

Location

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Victoria Alcaraz-Serrano

  Hospital Clinic of Barcelona

  PRINCIPAL INVESTIGATOR

• Beatriz Herrero-Cortina

  Hospital Clínico Universitario Lozano Blesa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Beatriz Herrero-Cortina

CONTACT

34653051357; Beafisiorespi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessors in charge of the measures will be blind to the group assignment of participants until the study has been completed
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Beatriz Herrero Cortina

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

Study Record Dates

• First Submitted: May 25, 2021
• First Posted: May 28, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 18, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)