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

NCT02324855 | Completed DMC

• 1 other identifier: Exacerb_BQnoFQ
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiectasis

Keywords

Autogenic drainage; Positive expiratory pressure; Airway clearance technique; Quality of life; Exacerbations; Chest physiotherapy

Outcome Measures

Primary Outcomes (1)

• Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)

  Auto-administered questionnaire: Leicester Cough Questionnaire

  1 year

Secondary Outcomes (5)

• Quality of life (Quality of life-Bronchiectasis questionnaire)

  1 year

• Exacerbation frequency

  1 year

• Exercise capacity (Incremental field test: shuttle test)

  1 year

• Lung function

  1 year

• Airway inflammation as assessed by spontaneous sputum analysis

  1 year

Study Arms (2)

Usual care

NO INTERVENTION

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

Subjects will introduce chest physiotherapy as part of their daily treatment

Other: Chest physiotherapy plus usual care

Interventions

Chest physiotherapy plus usual care OTHER

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).

Chest physiotherapy plus usual care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad San Jorge: lead
• Hospital Clinic of Barcelona: collaborator

Study Sites (1)

Universidad San Jorge

Zaragoza, 50830, Spain

Location

Related Publications (1)

• 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.

  PMID: 19541717 BACKGROUND

MeSH Terms

Conditions

Bronchiectasis

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Beatriz Herrero, Msc

  Universidad San Jorge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2014
• First Posted: December 24, 2014
• Study Start: October 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: May 18, 2021

Record last verified: 2021-05

Locations

ES (1)