NCT06443658 Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis
| NCT ID | NCT06443658 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta |
| Condition | Bronchiectasis Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 57 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-02 |
Trial Parameters
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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.
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