Bronchiectasis AdultPhase 3NCT06443658
Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis
A Phase 3 study testing Hypertonic saline, Isotonic saline and ELTGOL in people with Bronchiectasis Adult, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis Adult
- What is being tested?
- Hypertonic saline, Isotonic saline and ELTGOL
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2024to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
University Hospital of Girona Dr. Josep Trueta
Girona
Montse Vendrell, PhD MD
Gerard Muñoz, PhD PT
About this study
Official title: Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis
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.
Read the detailed description
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.
- Conditions
- Bronchiectasis Adult
- Being tested
- Hypertonic saline, Isotonic saline, ELTGOL
- Keywords
- airway clearance, hypertonic saline, respiratory physiotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic salineOther
Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique
Isotonic salineDrug
Also called Physiologic saline
Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique
ELTGOLOther
Patients from control group will perform the ELTGOL technique twice-daily
| Study group | Role | What they receive |
|---|---|---|
| ELTGOL group | Other | Control group. Patients will do twice-daily ELTGOL technique Receives: Other: ELTGOL |
| 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 Receives: Drug: Isotonic saline; Other: ELTGOL |
| 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 Receives: Other: Hypertonic saline; Other: ELTGOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the sputum weight in grams during intervention
Sputum weight will be measured with a precision balance after the intervention
Measured: Baseline and 12 months later
Secondary outcomes (20)
Change in sputum properties 1
Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)
Measured: Changes between Month 1 and Month 12
Change in sputum properties 2
Sputum properties will be evaluated analyzing solids in sputum
Measured: 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
Measured: Over the 12-month treatment period.
Change from baseline in the 24hours sputum weight
Sputum weight will be measured with a precision balance
Measured: 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)
Measured: Over the 12-month treatment period.
Number of exacerbations
Based on clinical history
Measured: Over the 12-month treatment period.
Time to the first exacerbation
Based on clinical history
Measured: 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)
Measured: Over the 12-month treatment period
Change in post-bronchodilator ( forced expiratory volume at one second) FEV1
Assessed with a forced spirometry
Measured: Over the 12-month treatment period in ml
Treatment adherence 1
Assessed through vial counting.
Measured: Over the 12-month treatment period
Treatment adherence 2
Assessed through the diary card.
Measured: 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)
Measured: 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)
Measured: Over the 12-month treatment period
Adverse events 2
Assessed by oxygen desaturation
Measured: Over the 12-month treatment period
Adverse events 3
Assessed by Visual Analogue Scale (VAS) scale (pain assessment)
Measured: Over the 12-month treatment period
Change in sputum weight during intervention
Sputum weight will be measured with a precision balance after the intervention
Measured: Between Month 12 and Month 13
Change in sputum volume in 24h sputum volume
Sputum volume will be measured with a calibrated container
Measured: 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)
Measured: Between Month 12 and Month 13
Change in post-bronchodilator FEV1
Assessed with a forced spirometry
Measured: 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)
Measured: Between Month 12 and Month 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2024
- Primary completionFeb 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Girona Dr. Josep Trueta, Germans Trias i Pujol Hospital
- Responsible party
- Sponsor
- Investigators
- Montserrat Vendrell, PhD MD, Principal investigator, University Hospital of Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443658
- Sponsor's protocol ID
- FISHT2021
- Status last verified
- Jul 2024
- First submitted
- 23 Jan 2024
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected data can be shared as long as it is for research collaboration
Publications
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.
PubMed 29326318Munoz 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.
PubMed 26902541
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Inhalation of Hypertonic Saline Solution Prior to ELTGOL Physiotherapy in Bronchiectasis
- ClinicalTrials.gov ID
- NCT06443658
- Acronym / sponsor ID
- FISHT2021
- Conditions
- Bronchiectasis Adult
- Keywords
- airway clearance, hypertonic saline, respiratory physiotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Collaborators
- University Hospital of Girona Dr. Josep Trueta, Germans Trias i Pujol Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ELTGOL group | Other | Other: ELTGOLControl group. Patients will do twice-daily ELTGOL technique |
| ELTGOL + isotonic saline solution (0,9%) | Placebo comparator | Drug: Isotonic saline, Other: ELTGOLPlacebo 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 | Other: Hypertonic saline, Other: ELTGOLExperimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic salinePatients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique | Other | ELTGOL + hypertonic saline solution (7%) |
| Isotonic salineAlso: Physiologic salinePatients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique | Drug | ELTGOL + isotonic saline solution (0,9%) |
| ELTGOLPatients from control group will perform the ELTGOL technique twice-daily | Other | ELTGOL + hypertonic saline solution (7%), ELTGOL + isotonic saline solution (0,9%), ELTGOL group |
Primary outcome
The change in the sputum weight in grams during intervention
Time frame: Baseline and 12 months later
Sputum weight will be measured with a precision balance after the intervention
20 secondary outcomes
Change in sputum properties 1
Time frame: Changes between Month 1 and Month 12
Change in sputum properties 2
Time frame: Changes between Month 1 and Month 12
Change from baseline in the 24hours sputum volume in milliliters
Time frame: Over the 12-month treatment period.
Change from baseline in the 24hours sputum weight
Time frame: Over the 12-month treatment period.
Change in cough
Time frame: Over the 12-month treatment period.
Number of exacerbations
Time frame: Over the 12-month treatment period.
Time to the first exacerbation
Time frame: Over the 12-month treatment period.
Change in quality of life
Time frame: Over the 12-month treatment period
Change in post-bronchodilator ( forced expiratory volume at one second) FEV1
Time frame: Over the 12-month treatment period in ml
Treatment adherence 1
Time frame: Over the 12-month treatment period
Treatment adherence 2
Time frame: Over the 12-month treatment period
Treatment adherence 3
Time frame: Over the 12-month treatment period
Adverse events 1
Time frame: Over the 12-month treatment period
Adverse events 2
Time frame: Over the 12-month treatment period
Adverse events 3
Time frame: Over the 12-month treatment period
Change in sputum weight during intervention
Time frame: Between Month 12 and Month 13
Change in sputum volume in 24h sputum volume
Time frame: Between Month 12 and Month 13
Change in cough
Time frame: Between Month 12 and Month 13
Change in post-bronchodilator FEV1
Time frame: Between Month 12 and Month 13
Change in quality of life
Time frame: Between Month 12 and Month 13
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 29326318Munoz 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.
- Background: PubMed 26902541Munoz 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.
- Individual participant dataSharing planned: Yes. All IPD collected data can be shared as long as it is for research collaboration
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Montserrat Vendrell, PhD MD principal investigator
University Hospital of Girona Dr. Josep Trueta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hypertonic saline, Isotonic saline and ELTGOL in people with Bronchiectasis Adult, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gerard Muñoz, PhD PT (0034-972940294, munoz.gerard@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change in the sputum weight in grams during intervention (time frame: Baseline and 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06443658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2024.