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

Sponsor

Universidad San Jorge (Other)

Overall Status

Completed

CT.gov ID

NCT02324855

Collaborator

Hospital Clinic of Barcelona (Other)

Enrollment

Location

Arms

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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

Actual 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 :

Oct 1, 2015

Actual Primary Completion Date :

Jun 1, 2020

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

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).

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).

Outcome Measures

Primary Outcome Measures

Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire) [1 year]
Auto-administered questionnaire: Leicester Cough Questionnaire

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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