Respiratory; Complications, TherapyELTGOLBQNCT01578681
ELTGOL and Bronchiectasis. Respiratory Therapy
A study testing Low Expiration Open glottis inferolateral (ELTGOL) and Stretching in people with Respiratory; Complications, Therapy and Bronchiectasis, run by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta at 1 site in Spain.
Trial summary
The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis. Primary objective: -To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Respiratory; Complications, Therapy, Bronchiectasis
- What is being tested?
- Low Expiration Open glottis inferolateral (ELTGOL) and Stretching
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2011to Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects ≥ 18 years old.
- Diagnosis of bronchiectasis using a high-resolution computed tomography (HRCT) chest scan performed in the last 2 years.
- Clinically stable disease (defined as no requirement for antibiotics for exacerbation in the 4 weeks preceding study entry.
- Chronic sputum expectoration >10ml/24h.
Who cannot join
- Bronchiectasis secondary to cystic fibrosis.
- Inability to perform physiotherapy techniques.
- Inability to attend the following controls.
- Treatment with mucolytics, DNase or hypertonic saline during the study.
- Smokers and ex-smokers ≥ 10 pack/year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis
The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.
Primary objective:
-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.
Secondary objectives:
- To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
- To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.
Read the detailed description
The incidence of bronchiectasis has increased in recent years resulting in greater costs, including periods of hospitalisation and the prescription of drugs.
The mucociliary clearance mechanism is impaired in these patients, and chest physiotherapy has been recommended for patients with bronchiectasis and chronic productive cough and/or evidence of mucus plugging on HRCT.
However, to date, there is insufficient evidence of benefits of chest physiotherapy through randomised controlled trials. Furthermore it rests unclear the most effective technique, the frequency and optimum duration of the RP and the most suitable variables to monitor.
A multicenter clinical trial into the efficacy of one chest physiotherapy technique in airway clearance will fill this important "gap" in the scientific evidence.
- Being tested
- Low Expiration Open glottis inferolateral (ELTGOL), Stretching
- Keywords
- bronchiectasis, respiratory therapy, airway clearance
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Expiration Open glottis inferolateral (ELTGOL)Procedure or surgery
Also called airway clearance
Place the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite.
StretchingProcedure or surgery
Patient will be instructed to do muscle stretching of the thorax
| Study group | Role | What they receive |
|---|---|---|
| Airway clearance, bronchiectasis | Active comparator | The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.
Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary. Receives: Procedure: Low Expiration Open glottis inferolateral (ELTGOL) |
| bronchiectasis, stretching | Placebo comparator | The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist.
Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary. Receives: Procedure: Stretching |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
The primary endpoint for the study is:
•Sputum volume during the procedure in the second visit and 24h post treatment which is defined as the volume of mucus expectorated during the physiotherapy procedure and 24h post treatment measured by ml.
Measured: 1 year
Secondary outcomes (1)
Side effects, knowledge
- To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
- To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2011
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory; Complications, TherapyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN, Sociedad Española de Neumología y Cirugía Torácica
- Responsible party
- Principal investigator, Dr. Montserrat Vendrell Relat, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Investigators
- Montserrat V Relat, Doctor, Principal investigator, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01578681
- Sponsor's protocol ID
- 08/10
- Acronym
- ELTGOLBQ
- Status last verified
- Nov 2017
- First submitted
- 13 Apr 2012
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
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 29326318
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis
- ClinicalTrials.gov ID
- NCT01578681
- Acronym / sponsor ID
- ELTGOLBQ / 08/10
- Keywords
- bronchiectasis, respiratory therapy, airway clearance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institut d'Investigació Biomèdica de Girona Dr. Josep TruetaUniversity, hospital or other
- Collaborators
- Spanish Clinical Research Network - SCReN, Sociedad Española de Neumología y Cirugía Torácica
- Study start
- Sep 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 17 Apr 2012 (estimated)
- 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.
The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.
Primary objective:
-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.
Secondary objectives:
- To evaluate the level of knowledge of airway clearance techniques and adherence to them in patients with bronchiectasis.
- To assess the side effects during the procedure: oxygen desaturation, increased dyspnea and hemoptysis.
Detailed description
The incidence of bronchiectasis has increased in recent years resulting in greater costs, including periods of hospitalisation and the prescription of drugs.
The mucociliary clearance mechanism is impaired in these patients, and chest physiotherapy has been recommended for patients with bronchiectasis and chronic productive cough and/or evidence of mucus plugging on HRCT.
However, to date, there is insufficient evidence of benefits of chest physiotherapy through randomised controlled trials. Furthermore it rests unclear the most effective technique, the frequency and optimum duration of the RP and the most suitable variables to monitor.
A multicenter clinical trial into the efficacy of one chest physiotherapy technique in airway clearance will fill this important "gap" in the scientific evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Airway clearance, bronchiectasis | Active comparator | Procedure: Low Expiration Open glottis inferolateral (ELTGOL)The patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist. Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary. |
| bronchiectasis, stretching | Placebo comparator | Procedure: StretchingThe patient would be selected randomly to one of the two groups (intervention or placebo). And follow up for one year with regular visits with the physician and the respiratory therapist. Each patient will be visited 7 times. At each visit all the variable will be registered. Patient will have also a personal registration diary. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- All subjects ≥ 18 years old.
- Diagnosis of bronchiectasis using a high-resolution computed tomography (HRCT) chest scan performed in the last 2 years.
- Clinically stable disease (defined as no requirement for antibiotics for exacerbation in the 4 weeks preceding study entry.
- Chronic sputum expectoration >10ml/24h.
Key exclusion criteria (5 listed)
- Bronchiectasis secondary to cystic fibrosis.
- Inability to perform physiotherapy techniques.
- Inability to attend the following controls.
- Treatment with mucolytics, DNase or hypertonic saline during the study.
- Smokers and ex-smokers ≥ 10 pack/year.
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 |
|---|---|---|
| Low Expiration Open glottis inferolateral (ELTGOL)Also: airway clearancePlace the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite. | Procedure or surgery | Airway clearance, bronchiectasis |
| StretchingPatient will be instructed to do muscle stretching of the thorax | Procedure or surgery | bronchiectasis, stretching |
Primary outcome
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
Time frame: 1 year
The primary endpoint for the study is: •Sputum volume during the procedure in the second visit and 24h post treatment which is defined as the volume of mucus expectorated during the physiotherapy procedure and 24h post treatment measured by ml.
1 secondary outcome
Side effects, knowledge
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
- Derived from this study: 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.
Related trials for Respiratory; Complications, Therapy
RecruitingObservational study
Real World Treatment Experience of Patients With Breast, Lung, Ovarian, Multiple Myeloma, or Acute Myelogenous Leukemia Using Remote Symptom Monitoring
Breast Cancer, Lung Cancer
RecruitingPhase 2
Administration of Autologous T-Cells Genetically Engineered to Express T-Cell Receptors Reactive Against Neoantigens in People With Metastatic Cancer
Endocrine Tumors, Non-Small Cell Lung Cancer
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Recruiting
A Study of a Side Effects and Resource Navigation Program for People With Cancer
Kidney Cancer, Bladder Cancer
RecruitingPhase 1
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
Gastric Cancer, Breast Cancer
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. This study is not recruiting at the moment.
Montserrat V Relat, Doctor principal investigator
Institut d'Investigació Biomèdica de 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 study testing Low Expiration Open glottis inferolateral (ELTGOL) and Stretching in people with Respiratory; Complications, Therapy and Bronchiectasis, 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 14 Nov 2017. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo (time frame: 1 year). 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 NCT01578681, which also lists 1 linked publication.
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 14 Nov 2017.