Inhalation of hypertonic saline before physiotherapy for bronchiectasis
Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis
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 |
| Enrollment | 57 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta Academic / other |
| Locations | 1 site (Girona) |
| Trial ID | NCT06443658 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults with stable non-cystic fibrosis bronchiectasis who experience chronic mucopurulent or purulent sputum.
Not a fit: Patients with asthma, cystic fibrosis, or those who have recently undergone mucoactive treatment may not benefit from this study.
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 performed: Previous studies have shown promise in using hypertonic saline for mucus clearance, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Girona
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.