Study to Test Inhalation of Hypertonic Saline Before ELTGOL Physiotherapy for Adults With Bronchiectasis

What this Trial Is About

Researchers are investigating treatments for bronchiectasis, a chronic lung disease where mucus clearance is impaired, leading to persistent infection and inflammation. The study aims to evaluate whether inhaling hypertonic saline before performing the ELTGOL physiotherapy technique can help loosen mucus and improve its removal. This approach is being tested in a phase 3, double-blind, randomized controlled trial to improve disease management and patient quality of life. Participants will be randomly assigned to one of three groups a control group performing the ELTGOL technique twice daily without inhalation, a placebo group inhaling isotonic saline before morning ELTGOL, or an experimental group inhaling hypertonic saline before morning ELTGOL. The intervention lasts 12 months, with inhalations administered once daily and ELTGOL performed twice daily. The study is conducted at multiple centers with triple blinding to ensure unbiased results. Throughout the 12-month study, participants will undergo regular assessments including sputum weight and volume measurements, cough evaluation, lung function tests FEV1, exacerbation monitoring, quality of life questionnaires, microbiological analysis, and adherence tracking. Safety and adverse events will also be recorded. The main outcome is the change in sputum weight from baseline to 12 months, with additional follow-up assessments conducted one month after the intervention period ends.

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