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Completed

NCT Number: NCT01854788

3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

Study design: a randomized, crossover trial. Each patient performed three different airway clearance techniques (Autogenic drainage, slow expiratory with glottis opened in lateral posture [ELTGOL], temporary- positive expiratory pressure [T-PEP] with not similar autonomy degree in a randomized order. Each technique were applied in 3 sessions during one week at alternate days (Monday /Wednesday/Friday or Tuesday/Thursday/Saturday). The time spent in each bronchial session was 40 minutes. Seven days were the wash-out time period between the different techniques.

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Key information

Conditions

Bronchiectasis Bronchial Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital CLinic

Barcelona, 08029, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • - Non Cystic Fibrosis bronchiectasis diagnosed by High Resolution Computed Tomographic
  • - Mean sputum production ≥ 15 ml /24h
  • - Clinical stability in the last 6 weeks
  • - Not carrying out regular chest physiotherapy
  • - Forced expiratory volume in 1 second ≥ 30% pred. ; Forced Vital Capacity ≥ 45% pred. and peak expiratory flow >270 L/s

Exclusion criteria

  • - Smoker or non-smoker form less than 2 years
  • - Cystic fibrosis
  • - Active tuberculosis or sarcoidosis

Treatment and study plan

Autogenic drainage

Other

It was performed following J. Chevallier recommendations.In this trial it was considered a self-administrated technique because physiotherapist only gave oral advice in order to ensure a correct performance of the technique.

Slow expiration with glottis opened in lateral posture

Other

It was performed following Postiaux´s recommendations. In this trial the technique was considered active-assisted because the physiotherapy played a role important in their execution.

Other names: Slow expiratory with glotis opened in lateral position

Temporary-positive expiratory pressure

Other

The diaphragmatic breathing was required for this technique whereas patients remain seated in front of the device with a nose clip. The inspiratory /expiratory ratio was 1:2.It was taken into account as a device-administrated technique for this trial.

Primary outcomes

  1. Weight of sputum expectorated during each airway clearance therapy session

    Time frame: 40 minutes

    Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.

  2. Weight of sputum expectorated 24 hours post each bronchial session

    Time frame: 24 hours

    Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams.

Secondary outcomes

  1. Saint George Respiratory Questionnaire (SGRQ)

    Time frame: Change from baseline at 5 weeks

    Saint George Respiratory Questionnaire (SGRQ) is a self-completed health-related quality of life questionnaire.It was validated in bronchiectasis. It was administrated at the start and at the end of trial.

  2. Leicester Cough Questionnaire (LCQ)

    Time frame: Changes from baseline arm to 1 week

    Leicester Cough Questionnaire is a self-completed quality of life measure of the impact of cough severity. It was validated in bronchiectasis. It was administrated at the start and at the end of each technique.

Other outcomes

  1. Lung function measured by simple spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75

    Time frame: Change from baseline arm to 1 week

  2. Likert test

    Time frame: Change from baseline arm to 1 week

    It is a patient´s preferences measure. The questionnaire consists of a package of simple questions about the airway clearance techniques.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
May 16, 2013
Registry last updated
May 16, 2013

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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