Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis
|ClinicalTrials.gov Identifier: NCT02324855|
Recruitment Status : Active, not recruiting
First Posted : December 24, 2014
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Other: Chest physiotherapy plus usual care||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||26 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Long Term Airway Clearance Therapy in Non Cystic Fibrosis Bronchiectasis: a Randomized Controlled Trial|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
No Intervention: 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.
Experimental: Chest physiotherapy plus usual care
Subjects will introduce chest physiotherapy as part of their daily treatment
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).
- Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire) [ Time Frame: 1 year ]Auto-administered questionnaire: Leicester Cough Questionnaire
- Quality of life (Quality of life-Bronchiectasis questionnaire) [ Time Frame: 1 year ]Auto-administered questionaire: Quality of Life- Bronchiectasis
- Exacerbation frequency [ Time Frame: 1 year ]Number of exacerbation
- Exercise capacity (Incremental field test: shuttle test) [ Time Frame: 1 year ]Incremental field test: shuttle test
- Lung function [ Time Frame: 1 year ]Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
- Airway inflammation as assessed by spontaneous sputum analysis [ Time Frame: 1 year ]Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02324855
|Universidad San Jorge|
|Zaragoza, Spain, 50830|
|Principal Investigator:||Beatriz Herrero, Msc||Universidad San Jorge|