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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial

Conditions
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Bronchiectasis

Intervention / Treatment
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* Other: Chest physiotherapy plus usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual care<br>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<br>Subjects will introduce chest physiotherapy as part of their daily treatment | Other: Chest physiotherapy plus usual care<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire) | Auto-administered questionnaire: Leicester Cough Questionnaire | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (Quality of life-Bronchiectasis questionnaire) | Auto-administered questionaire: Quality of Life- Bronchiectasis | 1 year | 
| Exacerbation frequency | Number of exacerbation | 1 year | 
| Exercise capacity (Incremental field test: shuttle test) | Incremental field test: shuttle test | 1 year | 
| Lung function | Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75 | 1 year | 
| Airway inflammation as assessed by spontaneous sputum analysis | Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8) | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autogenic drainage, Positive expiratory pressure, Airway clearance technique, Quality of life, Exacerbations, Chest physiotherapy