A Phase 3 interventional study of Hypertonic saline and Isotonic saline in Bronchiectasis Adult, sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-03.
Sponsored by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Phase 3, Interventional, and Treatment
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.
404 studies on the registry are indexed under Bronchiectasis; 125 are open to participants now.
This study's planned enrollment of 57 is close to the median of 60 across 263 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta is the lead sponsor of 31 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control group. Patients will do twice-daily ELTGOL technique
Other: ELTGOL
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
Drug: Isotonic saline · Other: ELTGOL
Experimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning
Other: Hypertonic saline · Other: ELTGOL
Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique
Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique
Also known as: Physiologic saline
Patients from control group will perform the ELTGOL technique twice-daily
The change in the sputum weight in grams during intervention
Sputum weight will be measured with a precision balance after the intervention
Time frame: Baseline and 12 months later
Change in sputum properties 1
Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)
Time frame: Changes between Month 1 and Month 12
Change in sputum properties 2
Sputum properties will be evaluated analyzing solids in sputum
Time frame: 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
Time frame: Over the 12-month treatment period.
Change from baseline in the 24hours sputum weight
Sputum weight will be measured with a precision balance
Time frame: 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)
Time frame: Over the 12-month treatment period.
Number of exacerbations
Based on clinical history
Time frame: Over the 12-month treatment period.
Time to the first exacerbation
Based on clinical history
Time frame: 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)
Time frame: Over the 12-month treatment period
Change in post-bronchodilator ( forced expiratory volume at one second) FEV1
Assessed with a forced spirometry
Time frame: Over the 12-month treatment period in ml
Treatment adherence 1
Assessed through vial counting.
Time frame: Over the 12-month treatment period
Treatment adherence 2
Assessed through the diary card.
Time frame: 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)
Time frame: 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)
Time frame: Over the 12-month treatment period
Adverse events 2
Assessed by oxygen desaturation
Time frame: Over the 12-month treatment period
Adverse events 3
Assessed by Visual Analogue Scale (VAS) scale (pain assessment)
Time frame: Over the 12-month treatment period
Change in sputum weight during intervention
Sputum weight will be measured with a precision balance after the intervention
Time frame: Between Month 12 and Month 13
Change in sputum volume in 24h sputum volume
Sputum volume will be measured with a calibrated container
Time frame: 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)
Time frame: Between Month 12 and Month 13
Change in post-bronchodilator FEV1
Assessed with a forced spirometry
Time frame: 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)
Time frame: Between Month 12 and Month 13
Plan to share: Yes — All IPD collected data can be shared as long as it is for research collaboration
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Once the manuscript is accepted for publication
Access criteria: Study data access will be provided for collaborative purposes
Started Jun 2024 (actual). Primary completion is estimated for Feb 2027, 32 months after the start.
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Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta