Clinical trial NCT01578681: ELTGOL and Bronchiectasis. Respiratory Therapy
Official title: Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory; Complications, Therapy
Bronchiectasis
Keywords: bronchiectasis
respiratory therapy
airway clearance
Lead sponsor: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor class: OTHER
Collaborators: name: Spanish Clinical Research Network - SCReN
name: Sociedad Española de Neumología y Cirugía Torácica
First posted: 2012-04-17
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo
timeFrame: 1 year
Secondary outcomes:
measure: Side effects, knowledge
timeFrame: 1 year
Other outcomes:
Locations:
city: Girona
country: Spain
facility: Hospital Universitari Dr. Josep Trueta
Study officials:
affiliation: Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
name: Montserrat V Relat, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.