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

Not Applicable

Completed

• Conditions: Bronchiectasis
• Interventions: Other: Chest physiotherapy plus usual care

• Registration Number: NCT02324855
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2014-12-01
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-24
• Study Start: 2015-10
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-17
• Last Update Posted: 2021-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chest physiotherapy plus usual care	Chest physiotherapy plus usual care	Subjects will introduce chest physiotherapy as part of their daily treatment

Primary Outcome Measures

Name	Time	Method
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)	1 year	Auto-administered questionnaire: Leicester Cough Questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of life (Quality of life-Bronchiectasis questionnaire)	1 year	Auto-administered questionaire: Quality of Life- Bronchiectasis
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)
Exercise capacity (Incremental field test: shuttle test)	1 year	Incremental field test: shuttle test
Exacerbation frequency	1 year	Number of exacerbation

Trial Locations

Locations (1)

Universidad San Jorge; 🇪🇸 Zaragoza, Spain