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| Name | Class |
|---|---|
| University Hospital of Girona Dr. Josep Trueta | NETWORK |
| Germans Trias i Pujol Hospital | OTHER |
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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.
Bronchiectasis is a prevalent chronic infectious disease with impaired mucociliary clearance. The persistence of high bacterial loads in the bronchi is associated with airway and systemic inflammation. Management is based on treatment of bronchial infection and on removal of secretions by airway clearance techniques (ACTs) although no therapy has been approved due to low quality of evidence. Inhalation of hypertonic saline (HS) could be useful in facilitate mucus removal especially if it is administer prior an effective ACT.Our hypothesis is that the long-term combination of HS and the ELTGOL technique will facilitate secretion removal in bronchiectasis and this will be associated with changes in mucus composition and better control of the disease.
Study design: A 12-month parallel-group, multicentre, double-blind randomised-controlled trial. Patients will be randomly assigned to receiving HS, isotonic saline (IS) or no inhalation before practicing ELTGOL technique.
The main objective is to evaluate the effect of the combination of once-daily inhaled HS and twice daily ELTGOL technique in mucus clearance in bronchiectasis. Secondary aims: to determine its effect on mucus properties, the impact of cough,exacerbations, quality of life, microbiology and pulmonary function; to evaluate adverse effects and adherence.
Study population: adult patients with non-cystic fibrosis bronchiectasis in stable state with chronic mucopurulent or purulent sputum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ELTGOL group | Other | Control group. Patients will do twice-daily ELTGOL technique |
|
| ELTGOL + isotonic saline solution (0,9%) | Placebo Comparator | 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 |
|
| ELTGOL + hypertonic saline solution (7%) | Experimental | Experimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hypertonic saline | Other | Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique |
|
| Measure | Description | Time Frame |
|---|---|---|
| The change in the sputum weight in grams during intervention | Sputum weight will be measured with a precision balance after the intervention | Baseline and 12 months later |
| Measure | Description | Time Frame |
|---|---|---|
| Change in sputum properties 1 | Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa) | Changes between Month 1 and Month 12 |
| Change in sputum properties 2 | Sputum properties will be evaluated analyzing solids in sputum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerard Muñoz, PhD PT | Contact | 0034-972940294 | munoz.gerard@gmail.com | |
| Neus Puigdevall, PT | Contact | 0034-972940294 | neuspuigde@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Montserrat Vendrell, PhD MD | University Hospital of Girona Dr. Josep Trueta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Girona Dr. Josep Trueta | Recruiting | Girona | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29326318 | Background | Munoz G, de Gracia J, Buxo M, Alvarez A, Vendrell M. Long-term benefits of airway clearance in bronchiectasis: a randomised placebo-controlled trial. Eur Respir J. 2018 Jan 11;51(1):1701926. doi: 10.1183/13993003.01926-2017. Print 2018 Jan. | |
| 26902541 | Background | Munoz G, Buxo M, de Gracia J, Olveira C, Martinez-Garcia MA, Giron R, Polverino E, Alvarez A, Birring SS, Vendrell M. Validation of a Spanish version of the Leicester Cough Questionnaire in non-cystic fibrosis bronchiectasis. Chron Respir Dis. 2016 May;13(2):128-36. doi: 10.1177/1479972316632005. Epub 2016 Feb 22. |
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All IPD collected data can be shared as long as it is for research collaboration
Once the manuscript is accepted for publication
Study data access will be provided for collaborative purposes
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| ID | Term |
|---|---|
| D012462 | Saline Solution, Hypertonic |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D006982 | Hypertonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
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| Isotonic saline | Drug | Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique |
|
|
| ELTGOL | Other | Patients from control group will perform the ELTGOL technique twice-daily |
|
| Changes between Month 1 and Month 12 |
| Change from baseline in the 24hours sputum volume in milliliters | Sputum volume will be measured with a calibrated container | Over the 12-month treatment period. |
| Change from baseline in the 24hours sputum weight | Sputum weight will be measured with a precision balance | Over the 12-month treatment period. |
| Change in cough | Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough) | Over the 12-month treatment period. |
| Number of exacerbations | Based on clinical history | Over the 12-month treatment period. |
| Time to the first exacerbation | Based on clinical history | Over the 12-month treatment period. |
| Change in quality of life | Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life) | Over the 12-month treatment period |
| Change in post-bronchodilator ( forced expiratory volume at one second) FEV1 | Assessed with a forced spirometry | Over the 12-month treatment period in ml |
| Treatment adherence 1 | Assessed through vial counting. | Over the 12-month treatment period |
| Treatment adherence 2 | Assessed through the diary card. | Over the 12-month treatment period |
| Treatment adherence 3 | Assessed through Morisky-Green test. Score from 0 to 4 (0 best and 4 worse adherence) | Over the 12-month treatment period |
| Adverse events 1 | Assessed by Borg scale at the end of interventions. Score 0-10 (0 best and 10 worse breathlessness) | Over the 12-month treatment period |
| Adverse events 2 | Assessed by oxygen desaturation | Over the 12-month treatment period |
| Adverse events 3 | Assessed by Visual Analogue Scale (VAS) scale (pain assessment) | Over the 12-month treatment period |
| Change in sputum weight during intervention | Sputum weight will be measured with a precision balance after the intervention | Between Month 12 and Month 13 |
| Change in sputum volume in 24h sputum volume | Sputum volume will be measured with a calibrated container | Between Month 12 and Month 13 |
| Change in cough | Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough) | Between Month 12 and Month 13 |
| Change in post-bronchodilator FEV1 | Assessed with a forced spirometry | Between Month 12 and Month 13 |
| Change in quality of life | Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life) | Between Month 12 and Month 13 |
| D006851 |
| Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |