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

U

Universidad San Jorge

Status

Completed

Conditions

Bronchiectasis

Treatments

Other: Chest physiotherapy plus usual care

Study type

Interventional

Funder types

Other

Identifiers

NCT02324855
Exacerb_BQnoFQ

Details and patient eligibility

About

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.

Full 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

Enrollment

26 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

26 participants in 2 patient groups

Usual care
No Intervention group
Description:
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.
Chest physiotherapy plus usual care
Experimental group
Description:
Subjects will introduce chest physiotherapy as part of their daily treatment
Treatment:
Other: Chest physiotherapy plus usual care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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