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

Bronchiectasis Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443658
• Other study ID #: FISHT2021
• Status: Recruiting
• Phase: Phase 3
• Start date: June 1, 2024
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
• Contact: Gerard Muñoz, PhD PT
• Phone: 0034-972940294
• Email: munoz.gerard[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 57
• Est. completion date: December 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis
• Bronchiectasis Adult

Intervention

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

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

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

Locations

Country	Name	City	State
Spain	University Hospital of Girona Dr. Josep Trueta	Girona

Sponsors (3)

Lead Sponsor	Collaborator
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta	Germans Trias i Pujol Hospital, University Hospital of Girona Dr.Josep Trueta

Country where clinical trial is conducted

Spain, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in sputum properties 1	Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)	Changes between Month 1 and Month 12
Secondary	Change in sputum properties 2	Sputum properties will be evaluated analyzing solids in sputum	Changes between Month 1 and Month 12
Secondary	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.
Secondary	Change from baseline in the 24hours sputum weight	Sputum weight will be measured with a precision balance	Over the 12-month treatment period.
Secondary	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.
Secondary	Number of exacerbations	Based on clinical history	Over the 12-month treatment period.
Secondary	Time to the first exacerbation	Based on clinical history	Over the 12-month treatment period.
Secondary	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
Secondary	Change in post-bronchodilator ( forced expiratory volume at one second) FEV1	Assessed with a forced spirometry	Over the 12-month treatment period in ml
Secondary	Treatment adherence 1	Assessed through vial counting.	Over the 12-month treatment period
Secondary	Treatment adherence 2	Assessed through the diary card.	Over the 12-month treatment period
Secondary	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
Secondary	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
Secondary	Adverse events 2	Assessed by oxygen desaturation	Over the 12-month treatment period
Secondary	Adverse events 3	Assessed by Visual Analogue Scale (VAS) scale (pain assessment)	Over the 12-month treatment period
Secondary	Change in sputum weight during intervention	Sputum weight will be measured with a precision balance after the intervention	Between Month 12 and Month 13
Secondary	Change in sputum volume in 24h sputum volume	Sputum volume will be measured with a calibrated container	Between Month 12 and Month 13
Secondary	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
Secondary	Change in post-bronchodilator FEV1	Assessed with a forced spirometry	Between Month 12 and Month 13
Secondary	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