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Clinical Trials in Spain / NCT06443658
Recruiting Phase 3

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

NCT06443658 · tracked via the Priya Life Science Spain tracker
Phase
Phase 3
Started
2024-06-01
Last updated
2024-07-03

Condition(s) studied

Bronchiectasis Adult

Investigational drug(s) / intervention(s)

Hypertonic salineIsotonic salineELTGOL

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

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Hospital of Girona Dr. Josep Trueta Girona Spain Recruiting

More Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06443658 on ClinicalTrials.gov ↗ ← All trials in Spain