Clinical trial NCT06443658: Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis
Official title: Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Bronchiectasis Adult
Keywords: airway clearance
hypertonic saline
respiratory physiotherapy
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
Collaborators: name: University Hospital of Girona Dr.Josep Trueta
name: Germans Trias i Pujol Hospital
First posted: 2024-06-05
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The change in the sputum weight in grams during intervention
timeFrame: Baseline and 12 months later
Secondary outcomes:
measure: Change in sputum properties 1
timeFrame: Changes between Month 1 and Month 12
measure: Change in sputum properties 2
timeFrame: Changes between Month 1 and Month 12
measure: Change from baseline in the 24hours sputum volume in milliliters
timeFrame: Over the 12-month treatment period.
measure: Change from baseline in the 24hours sputum weight
timeFrame: Over the 12-month treatment period.
measure: Change in cough
timeFrame: Over the 12-month treatment period.
measure: Number of exacerbations
timeFrame: Over the 12-month treatment period.
measure: Time to the first exacerbation
timeFrame: Over the 12-month treatment period.
measure: Change in quality of life
timeFrame: Over the 12-month treatment period
measure: Change in post-bronchodilator ( forced expiratory volume at one second) FEV1
timeFrame: Over the 12-month treatment period in ml
measure: Treatment adherence 1
timeFrame: Over the 12-month treatment period
measure: Treatment adherence 2
timeFrame: Over the 12-month treatment period
measure: Treatment adherence 3
timeFrame: Over the 12-month treatment period
measure: Adverse events 1
timeFrame: Over the 12-month treatment period
measure: Adverse events 2
timeFrame: Over the 12-month treatment period
measure: Adverse events 3
timeFrame: Over the 12-month treatment period
measure: Change in sputum weight during intervention
timeFrame: Between Month 12 and Month 13
measure: Change in sputum volume in 24h sputum volume
timeFrame: Between Month 12 and Month 13
measure: Change in cough
timeFrame: Between Month 12 and Month 13
measure: Change in post-bronchodilator FEV1
timeFrame: Between Month 12 and Month 13
measure: Change in quality of life
timeFrame: Between Month 12 and Month 13
Other outcomes:
Locations:
city: Girona
country: Spain
facility: University Hospital of Girona Dr. Josep Trueta
Study officials:
affiliation: University Hospital of Girona Dr.Josep Trueta
name: Montserrat Vendrell, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.