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Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis

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ClinicalTrials.gov Identifier: NCT02324855
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : May 30, 2019
Sponsor:
Collaborator:
Hospital Clinic of Barcelona
Information provided by (Responsible Party):
Universidad San Jorge

Brief Summary:
The main aim is to analyze whether the routine use of chest physiotherapy in non cystic fibrosis bronchiectasis (NCFB) improves the cough severity and the quality of life in this population. In addition, the secondary end-points include incidences of exacerbations, changes in lung function, exercise capacity, airways inflammation, sputum analysis and eventual adverse events.

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Chest physiotherapy plus usual care Not Applicable

Detailed Description:

The present project will be a single-blind , randomized, controlled trial of 12-month daily performing chest physiotherapy compared with usual care, followed by a 3-month intervention-free in non-cystic fibrosis bronchiectasis.

Intervention group will perform daily autonomous airway clearance techniques (positive expiratory pressure technique through Acapella device and autogenic drainage technique). Patients will receive professional sessions once a month.

Control group will receive their usual care and educational sessions about their disease. Physiotherapist will call them once a month.

During the study period the patients' pharmacological treatment remained unchanged


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial
Study Start Date : October 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
No Intervention: Usual care
Subjects will receive the usual medical care in accordance with Spanish non cystic fibrosis bronchiectasis guidelines. In addition they will receive educational sessions about their disease and their pharmacology treatment.
Experimental: Chest physiotherapy plus usual care
Subjects will introduce chest physiotherapy as part of their daily treatment
Other: Chest physiotherapy plus usual care
Subjects will perform daily chest physiotherapy during at least 30 minutes. Patients will perform a slow expiratory airway clearance technique combined with positive expiratory pressure device (Acapella device, Murray et al.) Each patient will receive 12 supervised professional sessions (once a month).




Primary Outcome Measures :
  1. Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire) [ Time Frame: 1 year ]
    Auto-administered questionnaire: Leicester Cough Questionnaire


Secondary Outcome Measures :
  1. Quality of life (Quality of life-Bronchiectasis questionnaire) [ Time Frame: 1 year ]
    Auto-administered questionaire: Quality of Life- Bronchiectasis

  2. Exacerbation frequency [ Time Frame: 1 year ]
    Number of exacerbation

  3. Exercise capacity (Incremental field test: shuttle test) [ Time Frame: 1 year ]
    Incremental field test: shuttle test

  4. Lung function [ Time Frame: 1 year ]
    Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75

  5. Airway inflammation as assessed by spontaneous sputum analysis [ Time Frame: 1 year ]
    Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Chronic sputum production during at least 3 months previous enrolment
  • At least two confirmed exacerbations during the last year
  • Patients able to understand how to perform the airway clearance techniques
  • Clinically stable at time of study entry (defined as no requirement for antibiotics or change in respiratory medication in the preceding 4 wk)
  • To be able to provide written, informed consent

Exclusion Criteria:

  • Cystic Fibrosis
  • Carry out regular chest physiotherapy.
  • Active haemoptysis during the previous month or recurrent hemoptysis during the last year (more than 4 episodes)
  • Waiting a pulmonary transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324855


Locations
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Spain
Universidad San Jorge
Zaragoza, Spain, 50830
Sponsors and Collaborators
Universidad San Jorge
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Beatriz Herrero, Msc Universidad San Jorge

Publications:
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Responsible Party: Universidad San Jorge
ClinicalTrials.gov Identifier: NCT02324855     History of Changes
Other Study ID Numbers: Exacerb_BQnoFQ
First Posted: December 24, 2014    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019

Keywords provided by Universidad San Jorge:
Autogenic drainage
Positive expiratory pressure
Airway clearance technique
Quality of life
Exacerbations
Chest physiotherapy

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases