3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

Study Overview
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Brief Summary
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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.

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

Conditions
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Bronchiectasis

Intervention / Treatment
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* Other: Autogenic drainage
* Other: Slow expiration with glottis opened in lateral posture
* Other: Temporary-positive expiratory pressure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autogenic drainage<br>All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes | Other: Autogenic drainage<br>* 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.<br>|
| Active Comparator: Slow expiration with glottis opened in lateral posture<br>All patients performed all interventions in a randomized order.Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes | Other: Slow expiration with glottis opened in lateral posture<br>* 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.<br>* Other names: Slow expiratory with glotis opened in lateral position;|
| Active Comparator: Temporary-Positive Expiratory Pressure<br>All patients performed all interventions in a randomized order. Each technique was applied in 3 non consecutively sessions during one week. The time spent during the session was 40 minutes | Other: Temporary-positive expiratory pressure<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight of sputum expectorated during each airway clearance therapy session | Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams. | 40 minutes | 
| Weight of sputum expectorated 24 hours post each bronchial session | Wet weight sputum production were recollected in one pre-weighted containers. It was measured in grams. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saint George Respiratory Questionnaire (SGRQ) | 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. | Change from baseline at 5 weeks | 
| Leicester Cough Questionnaire (LCQ) | 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. | Changes from baseline arm to 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway clearance techniques, Mucus clearance, Chest physiotherapy, Autogenic drainage, Slow expiration with glottis opened in lateral posture(ELTGOL), Temporary-positive expiratory pressure (T-PEP), Non cystic fibrosis bronchiectasis