ELTGOL and Bronchiectasis. Respiratory Therapy (ELTGOLBQ)

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status: Completed

Conditions: Bronchiectasis; Respiratory; Complications, Therapy

Treatments: Procedure: Low Expiration Open glottis inferolateral (ELTGOL); Procedure: Stretching

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT01578681

08/10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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44 participants in 2 patient groups, including a placebo group

Airway clearance, bronchiectasis

Active Comparator group

Description:

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.

Treatment:

Procedure: Low Expiration Open glottis inferolateral (ELTGOL)

bronchiectasis, stretching

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Stretching