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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Hypertonic saline
Other interventionPatients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique
Isotonic saline
DrugPatients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique
ELTGOL
Other interventionPatients from control group will perform the ELTGOL technique twice-daily
Treatment groups
Trial outcomes
Primary outcomes
The change in the sputum weight in grams during intervention
Sputum weight will be measured with a precision balance after the intervention
Secondary outcomes
Change in sputum properties 1
Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)
Change in sputum properties 2
Sputum properties will be evaluated analyzing solids in sputum
Change from baseline in the 24hours sputum volume in milliliters
Sputum volume will be measured with a calibrated container
Change from baseline in the 24hours sputum weight
Sputum weight will be measured with a precision balance
Sponsors and contacts
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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