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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Chest physiotherapy plus usual care
Sponsored by
Universidad San Jorge
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Autogenic drainage, Positive expiratory pressure, Airway clearance technique, Quality of life, Exacerbations, Chest physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universidad San Jorge

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Chest physiotherapy plus usual care

Arm 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.

Subjects will introduce chest physiotherapy as part of their daily treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of life (Quality of life-Bronchiectasis questionnaire)
Auto-administered questionaire: Quality of Life- Bronchiectasis
Exacerbation frequency
Number of exacerbation
Exercise capacity (Incremental field test: shuttle test)
Incremental field test: shuttle test
Lung function
Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Airway inflammation as assessed by spontaneous sputum analysis
Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)

Full Information

First Posted
December 1, 2014
Last Updated
May 17, 2021
Sponsor
Universidad San Jorge
Collaborators
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT02324855
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad San Jorge
Collaborators
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Autogenic drainage, Positive expiratory pressure, Airway clearance technique, Quality of life, Exacerbations, Chest physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm 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.
Arm Title
Chest physiotherapy plus usual care
Arm Type
Experimental
Arm Description
Subjects will introduce chest physiotherapy as part of their daily treatment
Intervention Type
Other
Intervention Name(s)
Chest physiotherapy plus usual care
Intervention Description
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).
Primary Outcome Measure Information:
Title
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Description
Auto-administered questionnaire: Leicester Cough Questionnaire
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of life (Quality of life-Bronchiectasis questionnaire)
Description
Auto-administered questionaire: Quality of Life- Bronchiectasis
Time Frame
1 year
Title
Exacerbation frequency
Description
Number of exacerbation
Time Frame
1 year
Title
Exercise capacity (Incremental field test: shuttle test)
Description
Incremental field test: shuttle test
Time Frame
1 year
Title
Lung function
Description
Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75
Time Frame
1 year
Title
Airway inflammation as assessed by spontaneous sputum analysis
Description
Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beatriz Herrero, Msc
Organizational Affiliation
Universidad San Jorge
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidad San Jorge
City
Zaragoza
ZIP/Postal Code
50830
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
19541717
Citation
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.
Results Reference
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Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis

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