ELTGOL and Bronchiectasis. Respiratory Therapy

Not Applicable

Completed

• Conditions: Respiratory; Complications, Therapy; Bronchiectasis

• Registration Number: NCT01578681
• Lead Sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Brief 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.

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 Timeline

• Study Start: 2011-09
• Primary Completion: 2011-09
• Study First Submitted: 2012-04-13
• Study First Submitted QC: 2012-04-16
• Study First Posted: 2012-04-17
• Study Completion: 2017-03
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-13
• Last Update Posted: 2017-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo	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.

Secondary Outcome Measures

Name	Time	Method
Side effects, knowledge	1 year	* 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.

Trial Locations

Locations (1)

Hospital Universitari Dr. Josep Trueta; 🇪🇸 Girona, Spain