Inhalation of hypertonic saline before physiotherapy for bronchiectasis
Official title: Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis
Run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · NCT06443658 · Data updated 2026-11-12
This study is testing if inhaling a special salt solution before physiotherapy can help adults with bronchiectasis breathe better and feel healthier.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 57 (estimated) |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona) |
| Status | Recruiting |
| Started | June 1, 2024 |
| Main results expected | February 2027 |
| Study ends | December 2027 |
| Registry record updated | July 3, 2024 |
| Trial ID | NCT06443658 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with stable non-cystic fibrosis bronchiectasis who experience chronic mucopurulent or purulent sputum.
✕Probably not a fit
Patients with asthma, cystic fibrosis, or those who have recently undergone mucoactive treatment may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates the effects of inhaling hypertonic saline solution prior to the ELTGOL physiotherapy technique in adults with bronchiectasis. The study aims to determine if this combination can enhance mucus clearance, improve mucus properties, and ultimately lead to better disease management. It is a 12-month, multicenter, double-blind, randomized controlled trial where participants will be assigned to receive either hypertonic saline, isotonic saline, or no inhalation before physiotherapy. The primary focus is on evaluating the effectiveness of this approach in improving respiratory function and quality of life for patients.
Why it matters
Potential benefit: If successful, this approach could significantly improve mucus clearance and overall management of bronchiectasis, leading to better patient outcomes.
How similar studies have gone: Previous studies have shown promise in using hypertonic saline for mucus clearance, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University Hospital of Girona Dr. Josep Trueta
Girona, Spain Recruiting
Study contacts
- Principal investigator: Montserrat Vendrell, PhD MD — University Hospital of Girona Dr. Josep Trueta
- Study coordinator: Gerard Muñoz, PhD PT
- Email: munoz.gerard@gmail.com
- Phone: 0034-972940294
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.