Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis

Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis

Bronchiectasis is a chronic bronchial disease in which the usual capacity to remove secretions does not function correctly, causing mucus retention that leads to chronic infection. As with all infections, the use of antibiotics and puss removal are essential treatment elements. Physiotherapeutic techniques are used to assist in the removal of secretions, although these are time-consuming practices that need to be much better studied and which patients often do not continue practicing diligently. A physiotherapeutic technique called (Slow prolonged expiration in lateral decubitus) ELTGOL has been shown to be somewhat effective but as the mucus is viscous in this disorder, it can be difficult to get it to move. It is thought that saline solution inhalations may reduce mucus viscosity and could help to ease expectoration, facilitating the removal of the mucus by the physiotherapeutic technique. This project aims to test this hypothesis, which if true could represent an advance in the treatment of this severely debilitating disease.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis Adult
• Intervention / Treatment: Other: ELTGOL; Drug: Isotonic saline; Other: Hypertonic saline

Detailed Description

Bronchiectasis is a prevalent chronic infectious disease with impaired mucociliary clearance. The persistence of high bacterial loads in the bronchi is associated with airway and systemic inflammation. Management is based on treatment of bronchial infection and on removal of secretions by airway clearance techniques (ACTs) although no therapy has been approved due to low quality of evidence. Inhalation of hypertonic saline (HS) could be useful in facilitate mucus removal especially if it is administer prior an effective ACT.Our hypothesis is that the long-term combination of HS and the ELTGOL technique will facilitate secretion removal in bronchiectasis and this will be associated with changes in mucus composition and better control of the disease.

Study design: A 12-month parallel-group, multicentre, double-blind randomised-controlled trial. Patients will be randomly assigned to receiving HS, isotonic saline (IS) or no inhalation before practicing ELTGOL technique.

The main objective is to evaluate the effect of the combination of once-daily inhaled HS and twice daily ELTGOL technique in mucus clearance in bronchiectasis. Secondary aims: to determine its effect on mucus properties, the impact of cough,exacerbations, quality of life, microbiology and pulmonary function; to evaluate adverse effects and adherence.

Study population: adult patients with non-cystic fibrosis bronchiectasis in stable state with chronic mucopurulent or purulent sputum.

• Study Type: Interventional
• Enrollment (Estimated): 57
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Gerard Muñoz, PhD PT; Phone Number: 0034-972940294; Email: munoz.gerard@gmail.com
• Study Contact Backup: Name: Neus Puigdevall, PT; Phone Number: 0034-972940294; Email: neuspuigde@gmail.com

Study Locations

• Spain
  • Girona, Spain
    • Recruiting
    • University Hospital of Girona Dr. Josep Trueta
    • Contact: Montse Vendrell, PhD MD
    • Contact: Gerard Muñoz, PhD PT

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients with bronchiectasis confirmed by high resolution computed tomography
• No exacerbations in the previous month
• Chronic mucopurulent and purulent sputum
• ≥10ml daily expectoration
• At least one exacerbation in the previous year
• (Forced expiratory volume the 1st second) FEV1 ≥30% after bronchodilation
• Sign the informed consent

Exclusion Criteria:

• Current smokers or a smoking history of ≥20 p-y
• Asthma, allergic bronchopulmonary aspergillosis or Cystic Fibrosis
• Pregnant or lactating women
• Following mucoactive treatment in the previous month
• Inability to perform ELTGOL, spirometry or to attend visits
• Practicing pulmonary rehabilitation in the previous 6 months
• Change of treatment the previous month
• Uncontrolled hypertension

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ELTGOL group; Control group. Patients will do twice-daily ELTGOL technique	Other: ELTGOL; Patients from control group will perform the ELTGOL technique twice-daily
Placebo Comparator: ELTGOL + isotonic saline solution (0,9%); Placebo group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 0.9% saline before performing the ELTGOL technique in the morning	Other: ELTGOL; Patients from control group will perform the ELTGOL technique twice-daily; Drug: Isotonic saline; Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique; Other Names: Physiologic saline
Experimental: ELTGOL + hypertonic saline solution (7%); Experimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning	Other: ELTGOL; Patients from control group will perform the ELTGOL technique twice-daily; Other: Hypertonic saline; Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in the sputum weight in grams during intervention	Sputum weight will be measured with a precision balance after the intervention	Baseline and 12 months later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sputum properties 1	Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)	Changes between Month 1 and Month 12
Change in sputum properties 2	Sputum properties will be evaluated analyzing solids in sputum	Changes between Month 1 and Month 12
Change from baseline in the 24hours sputum volume in milliliters	Sputum volume will be measured with a calibrated container	Over the 12-month treatment period.
Change from baseline in the 24hours sputum weight	Sputum weight will be measured with a precision balance	Over the 12-month treatment period.
Change in cough	Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough)	Over the 12-month treatment period.
Number of exacerbations	Based on clinical history	Over the 12-month treatment period.
Time to the first exacerbation	Based on clinical history	Over the 12-month treatment period.
Change in quality of life	Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life)	Over the 12-month treatment period
Change in post-bronchodilator ( forced expiratory volume at one second) FEV1	Assessed with a forced spirometry	Over the 12-month treatment period in ml
Treatment adherence 1	Assessed through vial counting.	Over the 12-month treatment period
Treatment adherence 2	Assessed through the diary card.	Over the 12-month treatment period
Treatment adherence 3	Assessed through Morisky-Green test. Score from 0 to 4 (0 best and 4 worse adherence)	Over the 12-month treatment period
Adverse events 1	Assessed by Borg scale at the end of interventions. Score 0-10 (0 best and 10 worse breathlessness)	Over the 12-month treatment period
Adverse events 2	Assessed by oxygen desaturation	Over the 12-month treatment period
Adverse events 3	Assessed by Visual Analogue Scale (VAS) scale (pain assessment)	Over the 12-month treatment period
Change in sputum weight during intervention	Sputum weight will be measured with a precision balance after the intervention	Between Month 12 and Month 13
Change in sputum volume in 24h sputum volume	Sputum volume will be measured with a calibrated container	Between Month 12 and Month 13
Change in cough	Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough)	Between Month 12 and Month 13
Change in post-bronchodilator FEV1	Assessed with a forced spirometry	Between Month 12 and Month 13
Change in quality of life	Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life)	Between Month 12 and Month 13

Collaborators and Investigators

• Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Collaborators: Germans Trias i Pujol Hospital; University Hospital of Girona Dr.Josep Trueta
• Investigators: Principal Investigator: Montserrat Vendrell, PhD MD, University Hospital of Girona Dr.Josep Trueta

Publications and helpful links

General Publications

• Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan.
• Munoz G, Buxo M, de Gracia J, Olveira C, Martinez-Garcia MA, Giron R, Polverino E, Alvarez A, Birring SS, Vendrell M. Validation of a Spanish version of the Leicester Cough Questionnaire in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2016 May;13(2):128-36. doi: 10.1177/1479972316632005. Epub 2016 Feb 22.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: hypertonic saline; respiratory physiotherapy; airway clearance
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: FISHT2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All IPD collected data can be shared as long as it is for research collaboration
• IPD Sharing Time Frame: Once the manuscript is accepted for publication
• IPD Sharing Access Criteria: Study data access will be provided for collaborative purposes
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No