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

May 17, 2021 updated by: Universidad San Jorge

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Zaragoza, Spain, 50830
        • Universidad San Jorge

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough severity (Auto-administered questionnaire: Leicester Cough Questionnaire)
Time Frame: 1 year
Auto-administered questionnaire: Leicester Cough Questionnaire
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad San Jorge

Collaborators

Hospital Clinic of Barcelona

Investigators

  • Principal Investigator: Beatriz Herrero, Msc, Universidad San Jorge

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

June 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 1, 2014

First Submitted That Met QC Criteria

December 18, 2014

First Posted (Estimate)

December 24, 2014

Study Record Updates

Last Update Posted (Actual)

May 18, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Exacerb_BQnoFQ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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