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

NCT06443658 | Recruiting Phase 3 DMC

• 1 other identifier: FISHT2021
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bronchiectasis Adult

Keywords

airway clearance; hypertonic saline; respiratory physiotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (20)

• Change in sputum properties 1

  Changes between Month 1 and Month 12

• Change in sputum properties 2

  Changes between Month 1 and Month 12

• Change from baseline in the 24hours sputum volume in milliliters

  Over the 12-month treatment period.

• Change from baseline in the 24hours sputum weight

  Over the 12-month treatment period.

• Change in cough

  Over the 12-month treatment period.

Study Arms (3)

ELTGOL group

OTHER

Control group. Patients will do twice-daily ELTGOL technique

Other: ELTGOL

ELTGOL + isotonic saline solution (0,9%)

PLACEBO COMPARATOR

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

Drug: Isotonic saline; Other: ELTGOL

ELTGOL + hypertonic saline solution (7%)

EXPERIMENTAL

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: Hypertonic saline; Other: ELTGOL

Interventions

Hypertonic saline OTHER

Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique

ELTGOL + hypertonic saline solution (7%)

Isotonic saline DRUG

Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique

Also known as: Physiologic saline

ELTGOL + isotonic saline solution (0,9%)

ELTGOL OTHER

Patients from control group will perform the ELTGOL technique twice-daily

ELTGOL + hypertonic saline solution (7%); ELTGOL + isotonic saline solution (0,9%); ELTGOL group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: lead
• University Hospital of Girona Dr. Josep Trueta: collaborator
• Germans Trias i Pujol Hospital: collaborator

Study Sites (1)

University Hospital of Girona Dr. Josep Trueta

Girona, Spain

RECRUITING

Related Publications (2)

• 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.

  PMID: 29326318 BACKGROUND

• 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.

  PMID: 26902541 BACKGROUND

MeSH Terms

Interventions

Saline Solution, Hypertonic; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Montserrat Vendrell, PhD MD

  University Hospital of Girona Dr. Josep Trueta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerard Muñoz, PhD PT

CONTACT

0034-972940294; munoz.gerard@gmail.com

Neus Puigdevall, PT

CONTACT

0034-972940294; neuspuigde@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: June 5, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 3, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Once the manuscript is accepted for publication
• Access Criteria: Study data access will be provided for collaborative purposes

Locations

ES (1)