Clinical trial NCT02324855: Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis
Official title: Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiectasis
Keywords: Autogenic drainage
Positive expiratory pressure
Airway clearance technique
Quality of life
Exacerbations
Chest physiotherapy
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
First posted: 2014-12-24
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life (Quality of life-Bronchiectasis questionnaire)
timeFrame: 1 year
measure: Exacerbation frequency
timeFrame: 1 year
measure: Exercise capacity (Incremental field test: shuttle test)
timeFrame: 1 year
measure: Lung function
timeFrame: 1 year
measure: Airway inflammation as assessed by spontaneous sputum analysis
timeFrame: 1 year
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad San Jorge
Study officials:
affiliation: Universidad San Jorge
name: Beatriz Herrero, Msc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray MP, Pentland JL, Hill AT. A randomised crossover trial of chest physiotherapy in non-cystic fibrosis bronchiectasis. Eur Respir J. 2009 Nov;34(5):1086-92. doi: 10.1183/09031936.00055509. Epub 2009 Jun 18.