Brief Title
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
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
Study Type
Interventional
Primary Outcome
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Secondary Outcome
Quality of life (Quality of life-Bronchiectasis questionnaire)
Condition
Bronchiectasis
Intervention
Chest physiotherapy plus usual care
Study Arms / Comparison Groups
Usual care
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
26
Start Date
October 2015
Completion Date
June 2020
Primary Completion Date
June 2020
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Beatriz Herrero, Msc, ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02324855
Organization ID
Exacerb_BQnoFQ
Responsible Party
Sponsor
Study Sponsor
Universidad San Jorge
Collaborators
Hospital Clinic of Barcelona
Study Sponsor
Beatriz Herrero, Msc, Principal Investigator, Universidad San Jorge
Verification Date
May 2019