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3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

Primary Purpose

Bronchiectasis

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Autogenic drainage

Slow expiration with glottis opened in lateral posture

Temporary-positive expiratory pressure

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital CLinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Autogenic drainage

Slow expiration with glottis opened in lateral posture

Temporary-Positive Expiratory Pressure

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

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.

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01854788

First Posted

August 8, 2012

Last Updated

May 13, 2013

Sponsor

Hospital Clinic of Barcelona

1. Study Identification

Unique Protocol Identification Number

NCT01854788

Brief Title

3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2013

Overall Recruitment Status

Completed

Study Start Date

September 2010 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bronchiectasis

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Autogenic drainage

Arm Type

Active Comparator

Arm Description

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

Arm Title

Slow expiration with glottis opened in lateral posture

Arm Type

Active Comparator

Arm Description

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

Arm Title

Temporary-Positive Expiratory Pressure

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Autogenic drainage

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Slow expiration with glottis opened in lateral posture

Other Intervention Name(s)

Slow expiratory with glotis opened in lateral position

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Temporary-positive expiratory pressure

Intervention Description

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 Measure Information:

Title

Weight of sputum expectorated during each airway clearance therapy session

Description

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

Time Frame

40 minutes

Title

Weight of sputum expectorated 24 hours post each bronchial session

Description

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

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Saint George Respiratory Questionnaire (SGRQ)

Description

Time Frame

Change from baseline at 5 weeks

Title

Leicester Cough Questionnaire (LCQ)

Description

Time Frame

Changes from baseline arm to 1 week

Other Pre-specified Outcome Measures:

Title

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

Title

Likert test

Description

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

Time Frame

Change from baseline arm to 1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beatriz Herrero, Phy

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Eva Polverino, Doctor

Organizational Affiliation

Hospital Clinic of Barcelona

Official's Role

Study Director

Facility Information:

Facility Name

Hospital CLinic

City

Barcelona

ZIP/Postal Code

08029

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

32071136

Citation

Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.

Results Reference

derived

PubMed Identifier

26712530

Citation

Herrero-Cortina B, Vilaro J, Marti D, Torres A, San Miguel-Pagola M, Alcaraz V, Polverino E. Short-term effects of three slow expiratory airway clearance techniques in patients with bronchiectasis: a randomised crossover trial. Physiotherapy. 2016 Dec;102(4):357-364. doi: 10.1016/j.physio.2015.07.005. Epub 2015 Dec 1.

Results Reference

derived

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3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

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