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3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

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ClinicalTrials.gov Identifier: NCT01854788
Recruitment Status : Completed
First Posted : May 16, 2013
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Beatriz Herrero, Hospital Clinic of Barcelona

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Autogenic drainage Other: Slow expiration with glottis opened in lateral posture Other: Temporary-positive expiratory pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Comparative Study of Three Airway Clearance Techniques With Different Autonomy Degrees in Non Cystic Fibrosis Bronchiectasis: Randomized Cross-over Trial.
Study Start Date : September 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

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Arm Intervention/treatment
Active Comparator: Autogenic drainage
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
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.

Active Comparator: Slow expiration with glottis opened in lateral posture
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
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 Name: Slow expiratory with glotis opened in lateral position

Active Comparator: Temporary-Positive Expiratory Pressure
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
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 Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. - Smoker or non-smoker form less than 2 years
  2. - Cystic fibrosis
  3. - Active tuberculosis or sarcoidosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01854788


Locations
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Spain
Hospital CLinic
Barcelona, Spain, 08029
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Beatriz Herrero, Phy Hospital Clinic of Barcelona
Study Director: Eva Polverino, Doctor Hospital Clinic of Barcelona
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Beatriz Herrero, Physiotherapist, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01854788    
Other Study ID Numbers: Uniko2010.01
First Posted: May 16, 2013    Key Record Dates
Last Update Posted: May 16, 2013
Last Verified: May 2013
Keywords provided by Beatriz Herrero, Hospital Clinic of Barcelona:
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
Additional relevant MeSH terms:
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Bronchiectasis
Fibrosis
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases