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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut d'Investigació Biomèdica de Girona Dr. Josep Trueta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients with bronchiectasis confirmed by high resolution computed tomography

No exacerbations in the previous month

Chronic mucopurulent and purulent sputum

≥10ml daily expectoration

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Hypertonic saline

    Other intervention

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

  • Isotonic saline

    Drug

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

  • ELTGOL

    Other intervention

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

Treatment groups

57 Participants
are divided into 3 treatment groups
Group A: ELTGOL groupOther 1 intervention
Group B: ELTGOL + isotonic saline solution (0,9%)Placebo comparator 2 interventions
Group C: ELTGOL + hypertonic saline solution (7%)Experimental treatment 2 interventions

Trial outcomes

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

Time frame
Baseline and 12 months later

Secondary outcomes

1

Change in sputum properties 1

Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)

Time frame
Changes between Month 1 and Month 12
2

Change in sputum properties 2

Sputum properties will be evaluated analyzing solids in sputum

Time frame
Changes between Month 1 and Month 12
3

Change from baseline in the 24hours sputum volume in milliliters

Sputum volume will be measured with a calibrated container

Time frame
Over the 12-month treatment period.
4

Change from baseline in the 24hours sputum weight

Sputum weight will be measured with a precision balance

Time frame
Over the 12-month treatment period.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Lead sponsor

University Hospital of Girona Dr. Josep Trueta

Collaborator

Germans Trias i Pujol Hospital

Collaborator