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OpenTrials
Completed

NCT Number: NCT02324855

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad San Jorge

Zaragoza, 50830, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chest physiotherapy plus usual care

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).

Primary outcomes

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

    Time frame: 1 year

    Auto-administered questionnaire: Leicester Cough Questionnaire

Secondary outcomes

  1. Quality of life (Quality of life-Bronchiectasis questionnaire)

    Time frame: 1 year

    Auto-administered questionaire: Quality of Life- Bronchiectasis

  2. Exacerbation frequency

    Time frame: 1 year

    Number of exacerbation

  3. Exercise capacity (Incremental field test: shuttle test)

    Time frame: 1 year

    Incremental field test: shuttle test

  4. Lung function

    Time frame: 1 year

    Simple spirometry: Forced expiratory volume at 1 second, Forced vital capacity, Forced expiratory flow 25-75

  5. Airway inflammation as assessed by spontaneous sputum analysis

    Time frame: 1 year

    Inflammatory sputum markers: Myeloperoxidase (MPO) and Cytokines (IL-8)

Sponsors and collaborators

Lead sponsor

Universidad San Jorge

Other

Collaborators

  • Hospital Clinic of Barcelona

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2014
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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