3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis

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

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.

Study Overview

• Status: Completed
• Conditions: Bronchiectasis
• Intervention / Treatment: Other: Autogenic drainage; Other: Slow expiration with glottis opened in lateral posture; Other: Temporary-positive expiratory pressure

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08029
    • Hospital Clínic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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 Names: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Hospital Clinic of Barcelona
• Investigators: Principal Investigator: Beatriz Herrero, Phy, Hospital Clinic of Barcelona; Study Director: Eva Polverino, Doctor, Hospital Clinic of Barcelona

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: August 8, 2012
• First Submitted That Met QC Criteria: May 13, 2013
• First Posted (Estimate): May 16, 2013

Study Record Updates

• Last Update Posted (Estimate): May 16, 2013
• Last Update Submitted That Met QC Criteria: May 13, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: Airway clearance techniques; Autogenic drainage; Chest physiotherapy; Non cystic fibrosis bronchiectasis; Mucus clearance; Slow expiration with glottis opened in lateral posture(ELTGOL); Temporary-positive expiratory pressure (T-PEP)
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Bronchial Diseases; Fibrosis; Bronchiectasis
• Other Study ID Numbers: Uniko2010.01