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

Bronchiectasis Clinical Trial

Official title:

Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02324855
• Other study ID #: Exacerb_BQnoFQ
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: June 2020

Study information

• Verified date: May 2021
• Source: Universidad San Jorge
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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).

Locations

Country	Name	City	State
Spain	Universidad San Jorge	Zaragoza

Sponsors (2)

Lead Sponsor	Collaborator
Universidad San Jorge	Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)	Auto-administered questionnaire: Leicester Cough Questionnaire	1 year
Secondary	Quality of life (Quality of life-Bronchiectasis questionnaire)	Auto-administered questionaire: Quality of Life- Bronchiectasis	1 year
Secondary	Exacerbation frequency	Number of exacerbation	1 year
Secondary	Exercise capacity (Incremental field test: shuttle test)	Incremental field test: shuttle test	1 year
Secondary	Lung function	Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75	1 year
Secondary	Airway inflammation as assessed by spontaneous sputum analysis	Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)	1 year