3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01854788
• Other study ID #: Uniko2010.01
• Status: Completed
• Phase: N/A
• First received: August 8, 2012
• Last updated: May 13, 2013
• Start date: September 2010
• Est. completion date: August 2012

Study information

• Verified date: May 2013
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital CLinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung function measured by simple spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75		Change from baseline arm to 1 week	No
Other	Likert test	It is a patient´s preferences measure. The questionnaire consists of a package of simple questions about the airway clearance techniques.	Change from baseline arm to 1 week	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No