Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 2
- Primary Endpoint
- Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Study Overview
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.
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Time Frame: 1 year
Auto-administered questionnaire: Leicester Cough Questionnaire
Secondary Outcomes
- Quality of life (Quality of life-Bronchiectasis questionnaire)(1 year)
- Lung function(1 year)
- Airway inflammation as assessed by spontaneous sputum analysis(1 year)
- Exercise capacity (Incremental field test: shuttle test)(1 year)
- Exacerbation frequency(1 year)