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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
University Hospital of Girona Dr. Josep Trueta
RECRUITING
Girona
Contact Information
Primary
Gerard Muñoz, PhD PT
munoz.gerard@gmail.com
0034-972940294
Backup
Neus Puigdevall, PT
neuspuigde@gmail.com
0034-972940294
Time Frame
Start Date: 2024-06-01
Estimated Completion Date: 2027-12
Participants
Target number of participants: 57
Treatments
Other: ELTGOL group
Control group. Patients will do twice-daily ELTGOL technique
Placebo_comparator: ELTGOL + isotonic saline solution (0,9%)
Placebo group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 0.9% saline before performing the ELTGOL technique in the morning
Experimental: ELTGOL + hypertonic saline solution (7%)
Experimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning
Related Therapeutic Areas
Sponsors
Leads: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Collaborators: Germans Trias i Pujol Hospital, University Hospital of Girona Dr.Josep Trueta

This content was sourced from clinicaltrials.gov