ELTGOL and Bronchiectasis. Respiratory Therapy
This trial is active, not recruiting.
|Conditions||respiratory; complications, therapy, bronchiectasis|
|Treatments||low expiration open glottis inferolateral (eltgol), stretching|
|Sponsor||Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta|
|Collaborator||Spanish Clinical Research Network - CAIBER|
|Start date||September 2011|
|End date||September 2011|
|Trial size||154 participants|
|Trial identifier||NCT01578681, 08/10|
The ELTGOL technique improves mucociliary clearance in adult patients with bronchiectasis.
-To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo.
- 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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
time frame: 1 year
Side effects, knowledge
time frame: 1 year
Male or female participants from 18 years up to 95 years old.
- 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.
- 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.
|Official title||Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis|
|Principal investigator||Montserrat V Relat, Doctor|
|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.|
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