ELTGOL and Bronchiectasis. Respiratory Therapy (ELTGOLBQ)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2012 by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Sponsor:
Collaborators:
Spanish Clinical Research Network - CAIBER
Sociedad Española de Neumología y Cirugía Torácica
Information provided by (Responsible Party):
Dr. Montserrat Vendrell Relat, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier:
NCT01578681
First received: April 13, 2012
Last updated: April 16, 2012
Last verified: April 2012
  Purpose

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.

Condition Intervention
Respiratory; Complications, Therapy
Bronchiectasis
Procedure: Low Expiration Open glottis inferolateral (ELTGOL)
Procedure: Stretching

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Placebo-controlled Trial to Evaluate the Efficacy of the ELTGOL Technique in the Drainage of Secretions in Patients With Bronchiectasis

Further study details as provided by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:

Primary Outcome Measures:
  • To evaluate the efficacy of ELTGOL in stable state patients with bronchiectasis compared to placebo [ Time Frame: 1 year ] [ Designated as safety issue: No ]

    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:
  • Side effects, knowledge [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    • 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.


Estimated Enrollment: 154
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Airway clearance, bronchiectasis

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.

Procedure: Low Expiration Open glottis inferolateral (ELTGOL)
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.
Other Name: airway clearance
Placebo Comparator: bronchiectasis, stretching

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.

Procedure: Stretching
Patient will be instructed to do muscle stretching of the thorax
Other Name: stretching

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

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01578681

Contacts
Contact: Montserrat V Relat, Doctor 0034972940200 ext 2605 mvendrellrelat@gmail.com
Contact: Gerard M Castro, Phy 0034972940200 ext 2413 munoz.gerard@gmail.com

Locations
Spain
Hospital Universitari Dr. Josep Trueta Recruiting
Girona, Spain, 17007
Contact: Montserrat V Relat, Doctor    0034972940200 ext 2605    mvendrellrelat@gmail.com   
Contact: Gerard M Castro, Phy    0034972940200 ext 2413    munoz.gerard@gmail.com   
Sponsors and Collaborators
Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Spanish Clinical Research Network - CAIBER
Sociedad Española de Neumología y Cirugía Torácica
Investigators
Principal Investigator: Montserrat V Relat, Doctor Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
  More Information

No publications provided

Responsible Party: Dr. Montserrat Vendrell Relat, Pneumology Doctor, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
ClinicalTrials.gov Identifier: NCT01578681     History of Changes
Other Study ID Numbers: 08/10
Study First Received: April 13, 2012
Last Updated: April 16, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta:
bronchiectasis
respiratory therapy
airway clearance

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 14, 2014