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

NCT ID: NCT02324855

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2020-06-30

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

Conditions

Bronchiectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Usual care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Chest physiotherapy plus usual care

Subjects will introduce chest physiotherapy as part of their daily treatment

Group Type: EXPERIMENTAL

Chest physiotherapy plus usual care

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Clinic of Barcelona

OTHER

Sponsor Role: collaborator

Universidad San Jorge

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Herrero, Msc

Role: PRINCIPAL_INVESTIGATOR

Universidad San Jorge

Locations

Universidad San Jorge

Zaragoza, , Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 19541717 (View on PubMed)

Other Identifiers

Exacerb_BQnoFQ

Identifier Type: -

Identifier Source: org_study_id